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

October 31, 2016 updated by: BioMAS Ltd

A Phase II, Multicenter, Randomized, Double Blind, Vehicle Controlled Study Evaluating the Efficacy and Tolerability of AS101 15% Gel for External Genital Warts.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Females with external genital warts who meet the eligibility criteria will be randomly allocated in a blinded manner in 1:1 ratio to one of the 2 following study arms: (1) AS101 15% gel or (2) Vehicle. The patients will apply the study drug at home once daily (overnight) until complete clearance of external genital warts or for up to 14 weeks (98 days).

During therapy all patients will return to the clinic every 2 weeks plus/minus 3 days of the treatment visit for clinical assessments of the treated area.

At week 6 of treatment the investigator will evaluate the treated area for all patients. If the investigator determines that there is no change in the disease spread area or lesion number compared to Day 1, study therapy is to be discontinued prior to 14 weeks (98 days) of treatment and the patient will be considered as not cleared. Last observation carried forward (LOCF) method will be used to analyze such patients.

Patients who at week 6 were evaluated by the investigator to have a change in the disease spread area or lesion number compared to Day 1, will continue treatment until complete clearance of warts or up to a maximum of 14 weeks (98 days).

Patients who were evaluated during any of the treatment visits with complete clearance will stop to apply the study therapy, continue to be followed once per 4 weeks for 84 days (12 weeks) for safety and recurrence evaluation. Patients who completed treatment with partial clearance or patients who discontinued for reasons of other than complete clearance will be followed 28 days after discontinuation for disease progression and reference to other therapy if was recommended.

Should significant irritation or any other skin adverse reaction occur during the treatment period, study therapy may be held for up to 7 consecutive days on up to two separate occasions.

Unblinding: Patients will be revealed as to the nature of their treatment only after all patients have completed study.

In case of pregnancy or related serious adverse event the nature of the treatment will be revealed to the patient prior to end of study.

If the investigator determines that there is a disease progression in total lesion number or infected wart area size of the Day 1 treated area, study therapy is to be discontinued prior to 98 days of treatment.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • Ha'Emek Medical Center, Department of Gynecology and obstetrics
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Moshe Bustan, MD
      • Rehovot, Israel, 76100
        • Recruiting
        • Kaplan Medical Center, Department of Gynecology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alon Ben-Arie, MD
        • Sub-Investigator:
          • Dora Milman, MD
      • Safed, Israel, 13100
        • Recruiting
        • Ziv Medical Center, Department of Gynecology and obstetrics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Inbar Ben-Shachar, MD
        • Sub-Investigator:
          • David Peleg, MD
      • Tel-Aviv, Israel, 64239
        • Recruiting
        • Tel-Aviv Sourasky Medical Center, Department of Gynecology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dan Grisaru, MD PhD Prof
        • Sub-Investigator:
          • Jacob Niv, MD
        • Sub-Investigator:
          • Yifat Oxhorn, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AS101
Topical 15% AS101 gel, once a day (overnight)
Drug: 15% AS101 gel
Administration of Topical 15% AS101 once a day (overnight)
Placebo Comparator: Vehicle
Vehicle, Once a day topical application (Overnight)
Drug: Vehicle
Administration of Vehicle once a day (overnight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of warts and infected area size (absolute and percent) as compared to Day 1.
Time Frame: within 14 weeks of treatment
within 14 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: within 14 weeks of treatment and 3 months of follow up
within 14 weeks of treatment and 3 months of follow up
In complete responders assessment of time to complete clearance of warts.
Time Frame: within 14 weeks of treatment
within 14 weeks of treatment
In complete responders assessment of recurrence rate and time to recurrence.
Time Frame: Within 3 months of follow up post treatment
Within 3 months of follow up post treatment
Collection of patient's satisfaction data from treatment etc.
Time Frame: within 14 weeks of treatment
within 14 weeks of treatment
Assessment of tolerability to the 15% AS101 gel as expressed by patient's itching and burning reports.
Time Frame: within 14 weeks of treatment
within 14 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioMAS Ltd

Investigators

  • Principal Investigator: Shabtai Romano, MD, Ha'Emek Medical center, Department of Gynecology & obstetrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS101-IL#002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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