Safety and Efficacy Double Blind Vehicle Controlled Study of 15% AS101 Gel to Treat External Genital Warts

NCT01943630 | Unknown Phase 2

• 1 other identifier: AS101-IL#002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this double blind study is to determine whether topical 15% AS101 gel is effective and safe as compared to vehicle in the treatment of external genital warts in women.

Conditions

External Genital Warts

Keywords

HPV condyloma acuminata

Outcome Measures

Primary Outcomes (1)

• Change in number of warts and infected area size (absolute and percent) as compared to Day 1.

  within 14 weeks of treatment

Secondary Outcomes (5)

• Assessment of safety of AS101 15% gel as expressed by the occurence of local topical reactions such as erythema and edema and systemic reactions to the treatment

  within 14 weeks of treatment and 3 months of follow up

• In complete responders assessment of time to complete clearance of warts.

  within 14 weeks of treatment

• In complete responders assessment of recurrence rate and time to recurrence.

  Within 3 months of follow up post treatment

• Collection of patient's satisfaction data from treatment etc.

  within 14 weeks of treatment

• Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports.

  within 14 weeks of treatment

Study Arms (2)

AS101

ACTIVE COMPARATOR

Topical 15% AS101 gel, once a day (overnight)

Drug: 15% AS101 gel

Vehicle

PLACEBO COMPARATOR

Vehicle, Once a day topical application (Overnight)

Drug: Vehicle

Interventions

15% AS101 gel DRUG

Administration of Topical 15% AS101 once a day (overnight)

AS101

Vehicle DRUG

Administration of Vehicle once a day (overnight)

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at least 18 years of age and in good health;
• Must sign an ethics committee approved informed consent form and be able to adhere to study visits and protocol requirements;
• Women must agree to avoid sexual contact while the gel is on their skin;
• All study participants who are sexually active must use a protection method of contraception during treatment and for 60 days after completion of treatment;
• Patients with clinical diagnosis of external genital warts, in the external genitalia including vulva (labia minora and majora), inguinal folds, pubic area, perineum, perianal, or buttocks areas; two or more distinct external genital warts, and wart area to be treated that is equal to or less than 10 cm2.

You may not qualify if:

• Participation in an investigational trial within 30 days prior to screening;
• Previous participation in a trial investigating AS101 for any indication;
• Topical treatment for genital warts within 14 days of screening;
• Cutaneous surgery, including cryosurgery or laser, to genital area within 30 days of screening;
• Skin irritations of other clinical signs or symptoms associated with prior therapy.
• Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior to screening, and while on study;
• Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days prior to screening (patients on long-term suppressive antiviral therapy are eligible);
• Diagnosis of high-grade cervical dysplasia;
• Internal anogenital, vaginal, cervical warts or urethral meatal warts requiring treatment;
• Chronic or acute skin condition that might interfere with the treatment or evaluation of study drug effect;
• Screening laboratory tests results from a complete blood count (CBC), chemistry panel and urine pregnancy test obtained during screening:
• Must be within the site laboratory's defined normal reference ranges, and/or according to the Investigator's decision;
• Urine pregnancy test in females of childbearing potential must be negative;
• Inadequate renal function: Serum Creatinine \>2.0mg/dL (\>2.0 ULN);
• Inadequate liver function: Serum (total) Bilirubin \>2 mg/dl or ALT and/or AST greater than two times the upper limit of the reference range.

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (4)

Ha'Emek Medical Center, Department of Gynecology and obstetrics

Afula, 1834111, Israel

RECRUITING

Kaplan Medical Center, Department of Gynecology

Rehovot, 76100, Israel

RECRUITING

Ziv Medical Center, Department of Gynecology and obstetrics

Safed, 13100, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center, Department of Gynecology

Tel Aviv, 64239, Israel

RECRUITING

Study Officials

• Shabtai Romano, MD

  Ha'Emek Medical center, Department of Gynecology & obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BioMas Ltd

CONTACT

+972-72-2204004; papillomatrial@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 17, 2013
• Study Start: January 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

IL (4)