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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]

It is considered successful treatment a repigmentation of greater than or equal to 50% of the affected area assessed by VASI (vitiligo area scoring index).


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