Clinical trial NCT02147353: 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
Overall status: COMPLETED
Phase: NA
Conditions: External Genital Warts
Keywords: External Genital Warts
Sinecatechins
Cryotherapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Fougera Pharmaceuticals Inc.
First posted: 2014-05-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Complete Clearance,
timeFrame: at week 1, week 9, and week 17
Secondary outcomes:
measure: Number of Participants With Recurrence of Previously Treated EGW Lesions
timeFrame: at 24 week post-treatment period
measure: Number of Participants With Recurrence of Previously Treated EGW Lesions
timeFrame: at 48 week post-treatment period
measure: Local Skin Reactions
timeFrame: at 16 week treatment period
measure: Subjects With Partial Clearance of Lesions
timeFrame: At week 1, week 9, and week 17
measure: Mean Change in Number of Lesions
timeFrame: Week 1, week 9 and week 17
measure: Mean Change in Number of Lesions
timeFrame: At week 1, week 9, and week 17
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Gary Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.