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

NCT02147353 | Completed Results

• 1 other identifier: GCO 11-0860
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

External Genital Warts

Keywords

External Genital Warts; Sinecatechins; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 1, week 9, and week 17

Secondary Outcomes (6)

• Number of Participants With Recurrence of Previously Treated EGW Lesions

  at 24 week post-treatment period

• Number of Participants With Recurrence of Previously Treated EGW Lesions

  at 48 week post-treatment period

• Local Skin Reactions

  at 16 week treatment period

• Subjects With Partial Clearance of Lesions

  At week 1, week 9, and week 17

• Mean Change in Number of Lesions

  Week 1, week 9 and week 17

Study Arms (2)

Sinecatechins 15% Ointment & Cryotherapy

ACTIVE COMPARATOR

Cryotherapy and then Sinecatechins 15% Ointment 1 week later.

Drug: Sinecatechins 15% Ointment; Drug: Cryotherapy alone

Cryotherapy Alone

PLACEBO COMPARATOR

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

Sinecatechins 15% Ointment DRUG

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

Sinecatechins 15% Ointment & Cryotherapy

Cryotherapy alone DRUG

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

Also known as: Cryosurgery

Cryotherapy Alone; Sinecatechins 15% Ointment & Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Fougera Pharmaceuticals Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 25607709 RESULT

MeSH Terms

Interventions

green tea extract polyphenone E; Ointments; Cryotherapy; Cryosurgery

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Shelbi C. Jim On
• Organization: Icahn School of Medicine at Mount Sinai

shelbi.jimon@mountsinai.org

212-241-6500

Study Officials

• Gary Goldenberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 26, 2014
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (1)