Clinical Trial: Efficacy and Safety of ACH24 in the Treatment of Vitiligo
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo
Brief Summary: This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo.
Detailed Summary: To evaluate the efficacy and safety of ACH24 compared to placebo in the treatment of vitiligo.The present study aims to register a new product in the country, the ACH24 for the treatment of vitiligo.
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Current Primary Outcome: Repigmentation of the affected area assessed by VASI (vitiligo area scoring index). [ Time Frame: Baseline compared to the end of 18 months of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of life questionnaire [ Time Frame: Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18) ]Dermatology Life Quality Index (DLQI)
- Safety descriptive about occurence of adverse events, evaluation of results of general physical examination. [ Time Frame: Will be evaluated during whole study, at the baseline and after 18 months of treatment ]Collection of safety data throughout the whole study period
Original Secondary Outcome: Same as current
Information By: Ache Laboratorios Farmaceuticos S.A.
Dates:
Date Received: August 17, 2011
Date Started: January 2012
Date Completion:
Last Updated: March 15, 2016
Last Verified: March 2016