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CompletedNCT03487549COVE-1Updated Nov 27, 2024Results posted

Cantharidin and Occlusion in Verruca Epithelium

A Phase 2 interventional study of VP-102 Cantharidin topical film forming solution and VP-102 Cantharidin, topical film forming solution in Common Wart, Warts Hand and Warts, sponsored by Verrica Pharmaceuticals Inc.. Completed at 5 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Verrica Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
2 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Warts with a site in United States — 7 open to participants now, 10 under way, 4 of them phase 3. Warts · United States.

Enrollment
36th of 58
56 · median 80
Started
2018
with 3 others
Phase 2
23 of 59
1 open now
Registered
37th of 59
by date
Lead sponsor
6 of 59
Verrica Pharmaceuticals Inc.

Among the 59 studies in Warts with a site in United States, this one is the 36th largest by enrollment of the 58 interventional ones that give a count, is one of 4 that started in 2018, is one of 23 in phase 2, and was the 37th registered.

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

Browse Warts studies →

Open to participants now

7 of the 59 studies in Warts with a site in United States are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 18 Warts studies recruiting now, 10 (56%) set no upper age limit and 8 (44%) stop at 75 or younger; 12 take children under 18; 1 take healthy volunteers.

This study: 2 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.

Read the detailed description

The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.

The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.

03

Conditions studied

  • Common Wart
  • Warts Hand
  • Warts
  • Papillomavirus Infections
  • DNA Virus Infections
  • Skin Diseases, Viral
  • Skin Diseases, Infectious
  • Skin Diseases
  • Virus Diseases
  • Tumor Virus Infections
  • Verruca Vulgaris
  • Verruca
04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Be healthy, immunocompetent males or females at least 2 years of age and older for Cohort 1 and 12 years of age and older for Cohort 2.
  2. Present with 1-6 common warts (verruca vulgaris) located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, palms of the hands, volar surface of the fingers or toes, under the finger nails (near and on the sides of the nails is allowed for Cohort 1, but warts near and on the sides of the nail (e.g., periungual) are not allowed in Cohort 2), soles of the feet, or the anogenital area. (Warts within 10 mm of a mucosal surface should not be treated).
  3. Have warts that are ≤10 mm in diameter and ≤3 mm in height. (Subjects with warts that are adjacent, touching or clustered may be included so long as the combined diameter in the longest direction does not exceed 10 mm. Individual lesions that are adjacent, touching or clustered should be counted as distinct lesions for the purposes of tracking, inclusion and clearance)(subjects in Cohort 2 can be pared, when necessary and appropriate, prior to evaluating height eligibility) .
  4. Have warts that have been present for at least 4 weeks at the time of the baseline visit.
  5. Consent to having all warts treated (the physician must also be willing to treat all warts initially present).
  6. Be otherwise medically healthy with no medical history, physical examination or vital signs as determined by the investigator.
  7. Be free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Aes.
  8. Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
  9. Have the ability, or have a guardian with the ability, to follow study instructions and be likely to complete all study requirements.
  10. Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the Study drug during the course of the study.
  11. Provide written or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
  12. Provide written authorization for use and disclosure of protected health information.
  13. If participating in the optional photographic portion of the study, agree to allow photographs of warts to be taken at each Treatment Visit by the research team and agree to share photos taken at home with the research team via text, email or in-person upload.

Exclusion criteria

Exclusion Criteria:

  1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
  2. Are systemically or have required, or will require, systemic immunosuppressive or immunomodulatory medication (including oral or parenteral ) within 30 days prior to enrollment or during the course of the study. (Routine use of inhaled or intranasal corticosteroids during the study is allowed)
  3. Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk. (e.g., , systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes). NOTE: Immunizations and flu shots may be administered throughout the study, but not within 5 days before or after treatment.
  4. Have more than 6 common warts at baseline.
  5. Present with any verruca plana, mosaiform, filiform, subungual (under the nail), genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded.
  6. Have any warts present at baseline in an anatomic location that the subject, parent/guardian or the physician is unwilling to treat or are located in an area that cannot be easily occluded with tape.
  7. Have had any previous treatment of common warts including, but not limited to, the use of cantharidin, antivirals, retinoids, salicylic acid, lactic acid, hydrogen peroxide, candida antigen, diphencyprone, dinitrochlorobenzene, sandalwood oil, thuja oil, squaric acid dibutyl ester, povidone iodine, nitric oxide, curettage or freezing of warts in the past 14 days. In addition, these treatments or any other over-the-counter wart treatment should not be implemented during the course of the study.
  8. Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
  9. Have received another product as part of a clinical trial within 30 days prior to the first application of the Study drug.
  10. Currently have or have a history of epidermodysplasia verruciformis.
  11. Have a history of illness or any dermatologic disorder, which, in the opinion of the investigator, will interfere with accurate assessment of the warts or increase the risk of adverse events.
  12. Have an active or are undergoing treatment for any malignancy.
  13. Have a history or presence of medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
  14. Have a history or presence of or an idiosyncratic reaction to the Study drug or related compounds, or drug product (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
  15. Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
  16. Are sexually active or may become sexually active and are unwilling to practice responsible methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
  17. Are pregnant or breastfeeding.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    VP-102

    Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

    Combination Product: VP-102 Cantharidin topical film forming solution · Combination Product: VP-102 Cantharidin, topical film forming solution

Interventions

  • Combination productVP-102 Cantharidin topical film forming solution

    VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.

    Also known as: VP-102-Cantharidin, film forming solution, VP-102 - Cohort 1

  • Combination productVP-102 Cantharidin, topical film forming solution

    VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.

    Also known as: VP-102 Cantharidin, film forming solution, VP-102 - Cohort 2

06

What researchers measure

Primary outcomes

  1. Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

    Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).

    Time frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.

  2. Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

    Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).

    Time frame: Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)

Secondary outcomes

  1. Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

    Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).

    Time frame: Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).

  2. Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).

    Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).

    Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).

  3. Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

    Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.

    Time frame: Baseline, Day 14, 28, 42 and 84 (EOS)

  4. Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)

    Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).

    Time frame: Baseline, Day 84 (EOS)

  5. Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

    Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).

    Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).

  6. Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

    Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.

    Time frame: Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147

Other outcomes

  1. Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.

    Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  2. Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit

    Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  3. Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline

    Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.

    Time frame: Compare Treatment Visit 1 (Baseline) to End of Study (Day 84).

  4. Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline

    Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  5. Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)

    Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  6. Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.

    Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.

    Time frame: Baseline to Treatment Visits 2 (Day 21), 3 (Day 42), 4 (Day 63) through the End of Treatment (Day 84).

  7. Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)

    Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  8. Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline

    Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.

    Time frame: Baseline to Day 84 (EOT)

  9. Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline

    Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.

    Time frame: Baseline to EOT (Day 84)

  10. Cohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)

    Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).

    Time frame: Baseline, Day 14, 28, 42, and 84 (EOS)

  11. Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

    Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

    Time frame: Treatment Visit 1 (Baseline) to each follow-up visit Day 105, Day 126 and Day 147.

  12. Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147

    Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.

    Time frame: Baseline to follow-up visits on Day 105, Day 126 and Day 147

  13. Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

    Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

    Time frame: baseline to Day 105, Day 126 and Day 147

07

Results

Posted Sep 1, 2021

Participant flow

The protocol was originally designed with one- cohort, it was later modified to include two cohorts. Subjects in Cohort 1 completed enrollment prior to beginning enrollment of new Subjects into Cohort 2.

Participant flow — Overall Study
MilestoneCohort 1Cohort 2
Started2135
Completed1733
Not completed42
Withdrew: Protocol violation01
Withdrew: Lost to follow-up21
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryCohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).

Time frame:
Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Reported as:
Count of participants · Participants
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
ParticipantsCohort 1
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)4
PrimaryCohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).

Time frame:
Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
ParticipantsVP-102 - Cohort 2
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)18
SecondaryCohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).

Time frame:
Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).
Reported as:
Mean · Number of warts
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Number of wartsCohort 1
Baseline2.19 ± 1.569
End of Treatment Visit-0.95 ± 1.658
SecondaryCohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).

Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).

Time frame:
Baseline (Visit 1) to End of Treatment Visit (Day 84).
Reported as:
Mean · Percent change
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
Percent changeCohort 1
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).-31.19 ± 42.776
SecondaryCohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Time frame:
Baseline, Day 14, 28, 42 and 84 (EOS)
Reported as:
Count of participants · Participants
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
ParticipantsCohort 1
Complete Clearance Reported at any Visit?5
Complete Clearance Reported at Day 140
Complete Clearance Reported at Day 282
Complete Clearance Reported at Day 425
Complete Clearance Reported at Day 84 (EOS)4
SecondaryCohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).

Time frame:
Baseline, Day 84 (EOS)
Reported as:
Mean · change in wart count
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
change in wart countVP-102 - Cohort 2
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)-0.85 ± 1.064
SecondaryCohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)

Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).

Time frame:
Baseline (Visit 1) to End of Treatment Visit (Day 84).
Reported as:
Mean · percentage of change in wart count
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
percentage of change in wart countVP-102 - Cohort 2
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)-53.79 ± 55.241
SecondaryCohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Time frame:
Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
ParticipantsVP-102 - Cohort 2
Complete Clearance Reported at Day 21 (Treatment Visit 2)5
Complete Clearance Reported at Day 42 (Treatment Visit 3)7
Complete Clearance Reported at Day 63 (Treatment Visit 4)12
Complete Clearance Reported at Day 84 (EOT)18
Complete Clearance Reported at Day 10516
Complete Clearance Reported at Day 12613
Complete Clearance Reported at Day 14713
Other pre-specifiedCohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.

Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Mean · Percent change in number of warts
Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.
Percent change in number of wartsCohort 1
Treatment Visit 2 Day 14-0.79 ± 3.637
Treatment Visit 3 Day 28-12.30 ± 30.462
Treatment Visit 4 Day 42-29.29 ± 42.845
EOS Day 84-31.19 ± 42.776
Other pre-specifiedCohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit

Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Mean · change in wart count
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit
change in wart countCohort 1
Treatment Visit 2-0.5 ± 0.218
Treatment Visit 3-0.43 ± 1.326
Treatment Visit 4-0.76 ± 1.446
End of Study-0.95 ± 1.658
Other pre-specifiedCohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline

Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.

Time frame:
Compare Treatment Visit 1 (Baseline) to End of Study (Day 84).
Reported as:
Count of participants · Participants
Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline
ParticipantsCohort 1
Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline7
Other pre-specifiedCohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline

Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Count of participants · Participants
Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline
ParticipantsCohort 1
Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline9
Other pre-specifiedCohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)

Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Count of participants · Participants
Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)
ParticipantsCohort 1
Reduction of >= 1 Wart from Baseline at any visit?9
Wart Reduction >= 1 Reported at Day 14 (Visit 2)1
Wart Reduction >= 1 Reported at Day 28 (Visit 3)4
Wart Reduction >= 1 Reported at Day 42 (Visit 4)8
Wart Reduction >= 1 Reported at Day 84 (EOS)7
Other pre-specifiedCohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.

Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.

Time frame:
Baseline to Treatment Visits 2 (Day 21), 3 (Day 42), 4 (Day 63) through the End of Treatment (Day 84).
Reported as:
Mean · percentage of change in wart count
Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.
percentage of change in wart countVP-102 - Cohort 2
Day 21 (Treatment Visit 2)-18.18 ± 37.119
Day 42 (Treatment Visit 3)-29.85 ± 41.392
Day 63 (Treatment Visit 4)-37.12 ± 53.078
Day 84 (End of Treatment Visit)-53.79 ± 55.241
Other pre-specifiedCohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Mean · change in wart count
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)
change in wart countVP-102 - Cohort 2
Day 21 (Treatment Visit 2)-0.39 ± 0.998
Day 42 (Treatment Visit 3)-0.48 ± 0.712
Day 63 (Treatment Visit 4)-0.52 ± 0.712
Day 84 (End of Treatment Visit)-0.85 ± 1.064
Other pre-specifiedCohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline

Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.

Time frame:
Baseline to Day 84 (EOT)
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline
ParticipantsVP-102 - Cohort 2
Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline19
Other pre-specifiedCohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline

Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.

Time frame:
Baseline to EOT (Day 84)
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline
ParticipantsVP-102 - Cohort 2
Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline23
Other pre-specifiedCohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)

Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).

Time frame:
Baseline, Day 14, 28, 42, and 84 (EOS)
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)
ParticipantsVP-102 - Cohort 2
Day 21 (Treatment Visit 2)7
Day 42 (Treatment Visit 3)13
Day 63 (Treatment Visit 4)15
Day 84 (End of Treatment Visit)20
Other pre-specifiedCohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Time frame:
Treatment Visit 1 (Baseline) to each follow-up visit Day 105, Day 126 and Day 147.
Reported as:
Count of participants · Participants
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147
ParticipantsVP-102 - Cohort 2
Complete Clearance Reported at Day 10516
Complete Clearance Reported at Day 12613
Complete Clearance Reported at Day 14713
Other pre-specifiedCohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.

Time frame:
Baseline to follow-up visits on Day 105, Day 126 and Day 147
Reported as:
Mean · percentage change from Baseline
Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147
percentage change from BaselineVP-102 - Cohort 2
Day 105-50.91 ± 54.736
Day 126-45.61 ± 52.556
Day 147-45.61 ± 52.556
Other pre-specifiedCohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147

Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.

Time frame:
baseline to Day 105, Day 126 and Day 147
Reported as:
Mean · change in wart count
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147
change in wart countVP-102 - Cohort 2
Day 105-0.82 ± 0.983
Day 126-0.73 ± 0.911
Day 147-0.73 ± 0.911

Adverse events

Collected over Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 10/21 (0%)0/21 (0%)20/21 (95.2%)
Cohort 20/34 (0%)0/35 (0%)32/34 (94.1%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventCohort 1Cohort 2
Application site vesiclesGeneral disorders20/2127/34
Application site painGeneral disorders20/2126/34
Application site erythemaGeneral disorders13/2119/34
Application site scabGeneral disorders8/2120/34
Application site pruritusGeneral disorders9/2116/34
Application site drynessGeneral disorders6/2113/34
Application site discolourationGeneral disorders1/218/34
Application site oedemaGeneral disorders4/216/34
Application site exfoliationGeneral disorders0/214/34
Application site erosionGeneral disorders0/213/34

Baseline characteristics

Study participants enrolled into Cohort 1 were not included in Cohort 2. New subjects were enrolled into Cohort 2.

Age, Categorical
Age, Categorical(Participants)VP-102 - Cohort 1VP-102 - Cohort 2Total
<=18 years5813
Between 18 and 65 years82634
>=65 years819
Age, Continuous
Age, Continuous(years)VP-102 - Cohort 1VP-102 - Cohort 2Total
Mean37.86 ± 21.24737.66 ± 16.43537.75 ± 18.212
Sex: Female, Male
Sex: Female, Male(Participants)VP-102 - Cohort 1VP-102 - Cohort 2Total
Female112233
Male101323
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VP-102 - Cohort 1VP-102 - Cohort 2Total
Hispanic or Latino112
Not Hispanic or Latino203454
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VP-102 - Cohort 1VP-102 - Cohort 2Total
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American505
White163450
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)VP-102 - Cohort 1VP-102 - Cohort 2Total
United States213556
Baseline wart count
Baseline wart count(Baseline wart count)VP-102 - Cohort 1VP-102 - Cohort 2Total
Mean2.19 ± 1.5691.65 ± 1.0981.85 ± 1.311
08

Study locations

5 sites
  • Cohort 2: Applied Research Center of Arkansas
    Little Rock, Arkansas 72212, United States
  • Cohort 2: Solutions Through Advanced Research
    Jacksonville, Florida 32256, United States
  • Cohort 2: The Indiana Clinical Trials Center
    Plainfield, Indiana 46168, United States
  • Cohort 2: Clarkston Skin Research
    Clarkston, Michigan 48346, United States
  • Cohort 1-Wake Research Associates
    Raleigh, North Carolina 27612, United States
09

References and documents

Publications

  • Guenthner S, McFalda W, Kwong P, Eads K, McCafferty M, Rieger J, Glover DK, Willson C, Burnett P, Olivadoti M. COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21. PubMed 34286459 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in May 2019, 13 months.

Results were first posted in Sep 2021, 2 years 3 months after primary completion.

Of 18 phase 2 interventional studies under Warts, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 13 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2018
First posted
Apr 4, 2018
StartActual
Mar 27, 2018
Primary completionActual
May 16, 2019
CompletionActual
Jul 15, 2019
Results first posted
Sep 1, 2021
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03487549
Lead sponsor
Verrica Pharmaceuticals Inc.
Collaborators
Instat Consulting, Inc., Paidion Research, Inc., BioClinica, Inc., ALMAC Clinical Services
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Mar 27, 2018
Primary completion
May 16, 2019
Completion
Jul 15, 2019
Results posted
Sep 1, 2021
Last update
Nov 27, 2024

Study contacts

Adnan Nasir, MD
principal investigator · Cohort 1: Wake Dermatology
Scott Guenthner, MD
principal investigator · Cohort 2: Indiana Clinical Trials Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: VP-102

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Verrica Pharmaceuticals Inc.

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