CompletedNCT02147353Updated Jun 14, 2019Results posted

Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment

An interventional study of Sinecatechins 15% Ointment and Cryotherapy alone in External Genital Warts, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-14.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 42
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

External Genital Warts (EGW) are the most common sexually transmitted disease associated with more than 30 types of the Human Papillomavirus (HPV). Cryotherapy is an effective method of EGW treatment. However, multiple sessions may be required with reported clearance rates ranging between 27-88%. Sinecatechins 15% ointment is Food and Drug Administration approved for three times daily application in immunocompetent subjects 18 years and older for the treatment of EGW and perianal warts. Treatment of EGW with cryotherapy followed by sinecatechins appears to be logical. Cryotherapy has direct cytodestructive effects with immediate short-term efficacy on treated EGW, while sinecatechins provide field therapy, treating both clinical and sub-clinical lesions. For this study, the investigators used sinecatechins 15% ointment twice daily regimen and anticipated that the synergistic effect with cryotherapy will provide better efficacy that cryotherapy alone. The investigators also anticipated that the sequential therapy with be safe.

Read the detailed description

A total of 42 subjects received standardized cryotherapy to all lesions, using two cycles of five seconds each, separated by a five second interval rest (Week 0/Baseline). One week following cryotherapy, subjects were randomized 1:1 to either additional treatment with sinecatechins 15% ointment twice daily or no additional treatment. Those subjects randomized to additional treatment received sinecatechins 15% ointment BID for up to sixteen weeks, or until complete clearance of all EGW, whichever occurred first. Additionally, subjects were advised to maintain safe sexual practices and have all recent sexual partners examined for EGW. Subjects were followed every 8 weeks for a total of 16 weeks (Table 1). EGW lesion counts were conducted at all study visits by the same qualified blinded evaluator. Additionally, at each visit local skin reactions, change in concomitant medications, and adverse events were assessed. Any subjects who received sinecatechins 15% ointment and discontinued prematurely were asked to return for an End of Study Visit. Females of childbearing potential underwent a urine pregnant test at all visits during study treatment period. Subjects that met complete responder criteria as above, were additionally followed and assessed at Visit5/Week 41 and Visit 6/Week 65 to assess for wart recurrence.

Conditions studied

External Genital Warts

Keywords

External Genital Warts
Sinecatechins
Cryotherapy

In context

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 772 studies on the registry; 175 are open to participants now.

Of its 124 completed or terminated interventional studies of FDA-regulated products, 83 (67%) have results posted.

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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

Adults at least 18 years old with at least two visible EGWs.
Subject must be in good general health as confirmed by the medical history.
Subject must be able to read, sign, and understand the informed consent.
Subject must be willing to forego any other treatments for his/her EGW lesions.
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 including concomitant medication and other treatment restrictions.
If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion criteria

Exclusion Criteria:

Subject with any evidence of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B or Hepatitis C.
Subject with an unstable medical condition as deemed by the clinical investigator.
Subject with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of EGW lesions.
Subject who has previously been treated in an EGW clinical trial, had treatment of anogenital warts or had systemic intake of virostatics or immunosuppressive medication within 30 days prior to Baseline Visit.
Women who are pregnant, lactating, or planning to become pregnant during the study period.
Subject who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
Subject who have active chemical dependency or alcoholism as assessed by the investigator.
Subject who have known allergies to any component of the study ointment.
Subject who have organ allograft, skin conditions that may interfere with study ointment, or having internal (vaginal or rectal) warts that have required treatment.
Subject who has received any of the following within 90 days prior to study treatment initiation:
- interferon or interferon inducers
- cytotoxic drugs
- immunomodulators or immunosuppressive therapies (inhaled/ intranasal corticosteroids are permitted)
- oral or parenteral corticosteroids
- topical corticosteroids if greater than 2 gm/day
- any dermatologic procedures or surgeries on the study area (including any EGW treatments)
Subject who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 42 participants (actual)

Study arms

Active comparator
Sinecatechins 15% Ointment & Cryotherapy
Cryotherapy and then Sinecatechins 15% Ointment 1 week later.
Drug: Sinecatechins 15% Ointment · Drug: Cryotherapy alone
Placebo comparator
Cryotherapy Alone
Cryotherapy will be standardized in all subjects and for all treated lesions: EGW lesions will be treated with 2 sprays, 5 seconds each, with a 5 second interval. All subjects will be treated with the same cryo-spray regimen.
Drug: Cryotherapy alone

Interventions

DrugSinecatechins 15% Ointment
Following cryotherapy, half of the subjects will be randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy (Week 1).
Also known as: Veregen
DrugCryotherapy alone
Cryotherapy will be standardized in all subjects and for all treated lesions.
Also known as: Cryosurgery

What researchers measure

Primary outcomes

Number of Participants With Complete Clearance,
Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.
Time frame: at week 1, week 9, and week 17

Secondary outcomes

Number of Participants With Recurrence of Previously Treated EGW Lesions
To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 24 week post-treatment period.
Time frame: at 24 week post-treatment period
Number of Participants With Recurrence of Previously Treated EGW Lesions
To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 48 week post-treatment period.
Time frame: at 48 week post-treatment period
Local Skin Reactions
To evaluate the safety of cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone as a regimen for EGW by evaluating for local skin reactions and adverse events. Number of participants with local skin reactions.
Time frame: at 16 week treatment period
Subjects With Partial Clearance of Lesions
Partial clearance is described as at least 50% reduction from baseline
Time frame: At week 1, week 9, and week 17
Mean Change in Number of Lesions
Mean change in number of lesions after 1 weeks, 9 weeks and 17 weeks post treatment as compared to baseline
Time frame: Week 1, week 9 and week 17
Mean Change in Number of Lesions
Mean change in number of lesions as compared to baseline at Week 1, Week 9 and Week 17 for the intent-to-treat population
Time frame: At week 1, week 9, and week 17

Results

Posted Jun 14, 2019

Participant flow

All patients were enrolled from September 2011 to December 2012.

Participant flow — Overall Study
Milestone	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Started	21	21
Completed	12	21
Not completed	9	0
Withdrew: Lost to follow-up	2	0
Withdrew: Unable to make visits	4	0
Withdrew: Medication noncompliance	3	0

Outcome measures

PrimaryNumber of Participants With Complete Clearance,

Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.

Time frame:: at week 1, week 9, and week 17
Reported as:: Number · participants

Number of Participants With Complete Clearance,
participants	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
at week 1	0	0
at week 9	3	5
at week 17	6	6

SecondaryNumber of Participants With Recurrence of Previously Treated EGW Lesions

To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 24 week post-treatment period.

Time frame:: at 24 week post-treatment period
Reported as:: Count of participants · Participants

Number of Participants With Recurrence of Previously Treated EGW Lesions
Participants	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Number of Participants With Recurrence of Previously Treated EGW Lesions	1	5

SecondaryNumber of Participants With Recurrence of Previously Treated EGW Lesions

Time frame:: at 48 week post-treatment period
Reported as:: Count of participants · Participants

Number of Participants With Recurrence of Previously Treated EGW Lesions
Participants	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Number of Participants With Recurrence of Previously Treated EGW Lesions	2	6

SecondaryLocal Skin Reactions

To evaluate the safety of cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone as a regimen for EGW by evaluating for local skin reactions and adverse events. Number of participants with local skin reactions.

Time frame:: at 16 week treatment period
Reported as:: Count of participants · Participants

Local Skin Reactions
Participants	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Local Skin Reactions	21	21

SecondarySubjects With Partial Clearance of Lesions

Partial clearance is described as at least 50% reduction from baseline

Time frame:: At week 1, week 9, and week 17
Reported as:: Number · participants

Subjects With Partial Clearance of Lesions
participants	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
at week 1	7	6
at week 9	15	9
at week 17	15	11

SecondaryMean Change in Number of Lesions

Mean change in number of lesions after 1 weeks, 9 weeks and 17 weeks post treatment as compared to baseline

Time frame:: Week 1, week 9 and week 17
Reported as:: Mean · number of lesions

Mean Change in Number of Lesions
number of lesions	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Week 1	-2.2 ± 3.93	-2.1 ± 3.83
Week 9	-5.4 ± 5.71	-2.7 ± 3.68
Week 17	-4.8 ± 7.87	-3.8 ± 5.49

SecondaryMean Change in Number of Lesions

Mean change in number of lesions as compared to baseline at Week 1, Week 9 and Week 17 for the intent-to-treat population

Time frame:: At week 1, week 9, and week 17
Reported as:: Mean · lesions

Mean Change in Number of Lesions
lesions	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
Week 1	-2.2 ± 3.93	-2.1 ± 3.83
Week 9	-5.0 ± 5.74	-2.1 ± 3.75
Week 17	-5.0 ± 6.90	-2.1 ± 4.73

Adverse events

Collected over Adverse event data were collected over 65 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sinecatechins 15% Ointment & Cryotherapy	0/21 (0%)	0/21 (0%)	21/21 (100%)
Cryotherapy Alone	0/21 (0%)	0/21 (0%)	21/21 (100%)

Most frequent other events

Most frequent other events
Event	Sinecatechins 15% Ointment & Cryotherapy	Cryotherapy Alone
local site reactionsSkin and subcutaneous tissue disorders	21/21	21/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Sinecatechins 15% Ointment and Cryotherapy	Cryotherapy Alone	Total
Mean	38.8 ± 5.2	35.8 ± 4.4	37.3 ± 4.8

Sex: Female, Male
Sex: Female, Male(Participants)	Sinecatechins 15% Ointment and Cryotherapy	Cryotherapy Alone	Total
Female	4	3	7
Male	17	18	35

Study locations

1 site

Icahn School of Medicine at Mount Sinai
New York, New York 10029, United States

References and documents

Publications

On SC, Linkner RV, Haddican M, Yaroshinsky A, Gagliotti M, Singer G, Goldenberg G. A single-blinded randomized controlled study to assess the efficacy of twice daily application of sinecatechins 15% ointment when used sequentially with cryotherapy in the treatment of external genital warts. J Drugs Dermatol. 2014 Nov;13(11):1400-5. PubMed 25607709 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02147353
Lead sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Fougera Pharmaceuticals Inc.
Responsible party: Gary Goldenberg (Assistant Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted: May 26, 2014
Start date: Sep 2011
Primary completion: Dec 2012
Completion: Dec 2012
Results posted: Jun 14, 2019
Last update: Jun 14, 2019

Study contacts

Gary Goldenberg, MD

principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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