Safety and Efficacy Study to Test Topical AS101 for External Genital Warts

NCT01555112 | Completed Phase 1 DMC

• 1 other identifier: AS101-IL#001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.

Conditions

Wart; External Genital Organs; Condyloma Acuminata

Outcome Measures

Primary Outcomes (1)

• The number of patients with Adverse Events and their severity

  up to 16 weeks

Secondary Outcomes (5)

• Number of patients with complete and partial clearance of external genital warts

  16 weeks

• Number of warts that were completely or partially cleared

  16 weeks

• Time to complete clearance

  16 weeks

• Recurrence rate in treatment area

  3 months follow up

• Time to recurrence

  3 months follow up

Study Arms (1)

Topical AS101

EXPERIMENTAL

15% AS101 ointment applied twice a day for treatment of external genital warts.

Drug: Topical AS101

Interventions

Topical AS101 DRUG

AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.

Topical AS101

Eligibility Criteria

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

You may qualify if:

• Women 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 ointment is on their skin;
• All study participants who are sexually active must use a barrier protection method of contraception such as condom in addition to another birth control measure such as oral contraceptives, intrauterine device, spermicide or surgical sterilization during treatment and for 60 days after completion of treatment;
• Patients with first 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;
• A minimum of one lesion and a maximum of 10 lesions identified at study entry, and the maximum diameter of the largest wart is no larger than 10 mm;
• Papanicolaou smears must be obtained in all females within 12 months of Day 1 and be negative for evidence of high grade intraepithelial neoplasia. Women with high grade intraepithelial neoplasia on cytology will be eligible if subsequent colposcopy with biopsy of suspicious area is negative for high grade squamous intraepithelial lesions (Grade 2 or 3). Atypia, HPV effect, and low grade intraepithelial lesions (Grade 1) are acceptable.

You may not qualify if:

• Participation in an investigational trial within 30 days prior to Day 1;
• Use of systemic steroids within 30 days of Day 1;
• Previous participation in a trial investigating AS101 for any indication.
• Any prior treatment for genital warts prior to participation;
• Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior Day 1, and while on study;
• Known history of HIV, HBV and HCV viral infection.
• Current active infection with herpes genitalis or history of herpes genitalis infection within the last 30 days prior to Day 1 (patients on long-term suppressive antiviral therapy are eligible);
• Current and/or recurrent pathologically relevant genital infections other than genital warts;
• Diagnosis of high-grade cervical dysplasia;
• Internal anogenital, vaginal, urethral and cervical warts requiring treatment;
• Chronic or acute skin condition that might interfere with the evaluation of the treatment or study drug effect;
• Cutaneous surgery, including cryosurgery, to genital area within 30 days of Day 1;
• Screening laboratory tests results from a complete blood count (CBC), chemistry panel, urine pregnancy test and urinalysis obtained during screening (Day -14 to Day 0):
• 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;

Sponsors & Collaborators

• BioMAS Ltd: lead

Study Sites (1)

Gynecology department, Haemek MC

Afula, Israel

Location

MeSH Terms

Conditions

Warts

Interventions

ammonium trichloro(dioxoethylene-O,O'-)tellurate

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shabtai Romano, MD

  Ha'Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

IL (1)