Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo
Overview
- Phase
- Phase 3
- Intervention
- Group 01
- Conditions
- Vitiligo
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Locations
- 1
- Primary Endpoint
- Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
- •Presence of generalized vitiligo;
- •Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.
Exclusion Criteria
- •Patients with:
- •Inflammatory diseases;
- •Alopecia Areata;
- •Diabetes Type I;
- •Collagen disease;
- •Atopic dermatitis;
- •Psoriasis;
- •Autoimmune thyroid disease (self reported). ¬ Thyroid problems (represents 15% of people with vitiligo), exclude only those who need to do treatment with corticosteroid or immunosuppressive.
- •Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
- •Woman in pregnancy or lactation period;
Arms & Interventions
Group 01
ACH24
Intervention: Group 01
Group 02
Placebo
Intervention: Group 02
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Quality of life questionnaire(Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18))
- Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.(Will be evaluated during whole study, at the baseline and after 18 months of treatment)