External Genital Warts Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02147353 -
Treatment of External Genital Warts With Cryotherapy and Sinecatechins 15% Ointment
|
N/A | |
| Completed |
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Phase 2 |