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

Primary Purpose

External Genital Warts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sinecatechins 15% Ointment

Cryotherapy alone

About this trial

This is an interventional treatment trial for External Genital Warts focused on measuring External Genital Warts, Sinecatechins, Cryotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sinecatechins 15% Ointment & Cryotherapy

Cryotherapy Alone

Arm Description

Cryotherapy and then Sinecatechins 15% Ointment 1 week later.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of Participants With Recurrence of Previously Treated EGW Lesions

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.

Subjects With Partial Clearance of Lesions

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

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

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

Full Information

NCT ID

NCT02147353

First Posted

May 22, 2014

Last Updated

June 12, 2019

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Fougera Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02147353

Brief Title

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

Official Title

An Investigator-Initiated Study to Assess the Safety and Efficacy of Sinecatechins 15% Ointment When Used in Conjunction With Cryotherapy in the Treatment of External Genital Warts

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Fougera Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

External Genital Warts

Keywords

External Genital Warts, Sinecatechins, Cryotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sinecatechins 15% Ointment & Cryotherapy

Arm Type

Active Comparator

Arm Description

Cryotherapy and then Sinecatechins 15% Ointment 1 week later.

Arm Title

Cryotherapy Alone

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sinecatechins 15% Ointment

Other Intervention Name(s)

Veregen

Intervention Description

Following cryotherapy, half of the subjects will be randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy (Week 1).

Intervention Type

Drug

Intervention Name(s)

Cryotherapy alone

Other Intervention Name(s)

Cryosurgery

Intervention Description

Cryotherapy will be standardized in all subjects and for all treated lesions.

Primary Outcome Measure Information:

Title

Number of Participants With Complete Clearance,

Description

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 Outcome Measure Information:

Title

Number of Participants With Recurrence of Previously Treated EGW Lesions

Description

Time Frame

at 24 week post-treatment period

Title

Number of Participants With Recurrence of Previously Treated EGW Lesions

Description

Time Frame

at 48 week post-treatment period

Title

Local Skin Reactions

Description

Time Frame

at 16 week treatment period

Title

Subjects With Partial Clearance of Lesions

Description

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

Time Frame

At week 1, week 9, and week 17

Title

Mean Change in Number of Lesions

Description

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

Title

Mean Change in Number of Lesions

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Goldenberg, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25607709

Citation

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.

Results Reference

result

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

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