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

• Status: Unknown status
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BioMAS Ltd
• Treatments: Ammonium trichloro(dioxoethylene-O,O'-)tellurate

Criteria

Inclusion Criteria:

1. Women at least 18 years of age and in good health;

2. Must sign an ethics committee approved informed consent form and be able to adhere to study visits and protocol requirements;

3. Women must agree to avoid sexual contact while the gel is on their skin;

4. All study participants who are sexually active must use a protection method of contraception during treatment and for 60 days after completion of treatment;

5. 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.

Exclusion criteria:

1. Participation in an investigational trial within 30 days prior to screening;

2. Previous participation in a trial investigating AS101 for any indication;

3. Topical treatment for genital warts within 14 days of screening;

4. Cutaneous surgery, including cryosurgery or laser, to genital area within 30 days of screening;

5. Skin irritations of other clinical signs or symptoms associated with prior therapy.

6. Topical and systemic immunosuppressive or immunomodulatory medications (including corticosteroids) within 30 days prior to screening, and while on study;

7. 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);

8. Diagnosis of high-grade cervical dysplasia;

9. Internal anogenital, vaginal, cervical warts or urethral meatal warts requiring treatment;

10. Chronic or acute skin condition that might interfere with the treatment or evaluation of study drug effect;

11. Screening laboratory tests results from a complete blood count (CBC), chemistry panel and urine pregnancy test obtained during screening:

1. Must be within the site laboratory's defined normal reference ranges, and/or according to the Investigator's decision;

2. Urine pregnancy test in females of childbearing potential must be negative;

3. Inadequate renal function: Serum Creatinine >2.0mg/dL (>2.0 ULN);

4. 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.

12. Uncontrolled infection or acute severe febrile illness;

13. Diagnosed as having uncontrolled cardiovascular, hematological, hepatic, neurological, renal, endocrine, vascular, autoimmune, or gastrointestinal abnormalities or disease;

14. Pregnant or lactating;

15. Known allergy to AS101 or any component of the investigational formulation; or

16. Subjects with any other clinically significant medical condition, psychiatric condition or laboratory abnormality which would, in the judgment of the Investigator, interfere with the subject's ability to participate and comply with the trial.