ClinicalTrials.gg
WithdrawnNCT03336372Updated Apr 1, 2022

Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients

An Early Phase 1 interventional study of Picato in Molluscum Contagiosum, sponsored by Center for Clinical Studies, Texas. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.

Sponsored by Center for Clinical Studies, Texas · Early Phase 1, Interventional, and Treatment

Why this study was withdrawn
Sponsor discontinued study on 8Sep2018
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

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

Among 15 studies in Molluscum Contagiosum with a site in United States — none open to participants now, none under way, none of them phase 3. Molluscum Contagiosum · United States.

Enrollment
14th of 15
0 · median 100
Started
2017
with 2 others
Phase 1
Only one
of the 15
Registered
7th of 15
by date
Lead sponsor
1 of 15
Center for Clinical Studies, Texas

Among the 15 studies in Molluscum Contagiosum with a site in United States, this one is the 14th largest by enrollment, is one of 3 that started in 2017, is the only one in phase 1, and was the 7th registered.

Molluscum Contagiosum

22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.

Browse Molluscum Contagiosum studies →

Open to participants now

None of the 15 studies in Molluscum Contagiosum with a site in United States is open now. The open studies under Molluscum Contagiosum, anywhere →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 15 studies in Molluscum Contagiosum with a site in United States as a file.
02

Study summary

Patients at least 18 years of age will be enrolled in the study to assess the efficacy and tolerability of Picato gel in the treatment of molluscum contagiosum. Patients must have an immunocompromised condition due to taking immunosuppressive drugs or having an inherited disease affecting the immune system.

03

Conditions studied

  • Molluscum Contagiosum

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04

Who can participate

Ages eligible
18 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

  • Male or non-pregnant female at least 18 years of age.
  • Subject must have an condition due to use of immunosuppressive therapies for cancer or disease treatment or prevention of organ transplant rejection or due to an inherited condition that affects the immune system.
  • Subject has at least 10 clinically typical, visible and discrete MCs within a treatment area on either the face and/or trunk. Treatment area is defined as either:

    • One contiguous treatment area of at most 100 cm2
    • Two non-contiguous treatment areas totaling at most 100 cm2
  • Subject must be willing to forego any other treatments of MC on the face and/or trunk, including tanning bed use and excessive sun exposure, throughout the duration of the trial.
  • Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods, and to comply with all study requirements.
  • Female subjects of must have a negative urine pregnancy test prior to trial treatment.
  • Female subjects of childbearing potential must be willing to use effective at trial entry and until the last follow-up visit at Week 24.

Exclusion criteria

Exclusion Criteria:

  • Location of the treatment area

    • on the periorbital skin
    • within 5 cm of an incompletely healed wound
    • within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
  • Previous participation in an ingenol mebutate trial.
  • Treatment with ingenol mebutate gel in the treatment area within 6 months or outside of the treatment area within 30 days prior to study treatment initiation.
  • Receipt of the following within 90 days prior to study treatment initiation:

    • interferons or interferon inducers
    • any dermatologic procedures or surgeries within the treatment area
  • Receipt of any topical prescription medications in the treatment area within 30 days prior to study treatment initiation.
  • Lesions in the treatment area have atypical clinical appearance (e.g. giant lesions greater than 5 mm, eczematous lesions, or folliculocentric lesions).
  • Active dermatologic conditions that may confound the diagnosis of MC or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, or psoriasis.
  • Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a severe AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the (sub)investigator's clinical judgment.
  • Known history of infection with (HIV).
  • History of melanoma.
  • History of chronic alcohol or drug abuse within 12 months prior to screening, or any condition associated with poor compliance as judged by the (sub)investigator.
  • Known or suspected allergy or reaction to any component of the IMP formulation.
  • Patients who have experienced a medical event within 90 days prior to study treatment initiation (e.g., stroke, myocardial infarction, etc).
  • Pregnant, breastfeeding, or lactating women.
  • Participation in any another interventional clinical trial within 30 days prior to study treatment initiation.
Terms in these criteria, in plain language(6)

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

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.

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.

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.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Picato topical gel

    Drug: Picato

Interventions

  • DrugPicato

    Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights

06

What researchers measure

Primary outcomes

  1. Complete clearance at Week 4

    Complete clearance is defined as no clinically visible MCs in the treatment area/

    Time frame: 4 weeks

Secondary outcomes

  1. Partial clearance at Week 4

    Partial clearance defined as at least 50% reduction in the number of clinically visible MCs in the treatment area.

    Time frame: 4 weeks

  2. Percentage of subjects who sustain complete clearance of MCs in the treatment area at Week 24

    Time frame: 24 weeks

  3. Percentage of subjects who clear MCs outside of the treatment area at Week 24

    Time frame: 24 weeks

Other outcomes

  1. Treatment Satisfaction Questionnaire for Medication

    Scale range from "extremely satisfied" to "extremely dissatisfied".

    Time frame: 24 weeks

  2. EQ-5D-5L Index and Health Status

    Scale range from 0 (worst health) to 100 (best health).

    Time frame: 24 weeks

07

Study locations

1 site
  • Center for Clinical Studies
    Houston, Texas 77004, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Sep 2018, 8 months.

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

Registered
Nov 6, 2017
First posted
Nov 8, 2017
StartActual
Dec 20, 2017
Primary completionActual
Sep 8, 2018
CompletionActual
Oct 16, 2018
Last update
Apr 1, 2022
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 Apr 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03336372
Lead sponsor
Center for Clinical Studies, Texas
Collaborators
LEO Pharma
Responsible party
Sponsor
First posted
Nov 8, 2017
Start date
Dec 20, 2017
Primary completion
Sep 8, 2018
Completion
Oct 16, 2018
Last update
Apr 1, 2022

Study contacts

Stephen K Tyring, MD, PhD
study director · Center for Clinical Studies

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ingenol mebutate

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