Efficacy and Safety of ACH24 in the Treatment of Vitiligo

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: Group 01
* Drug: Group 02


Participation Criteria
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Eligibility Criteria
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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; Asthma; 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; Known allergic reaction against the phytomedicine as assessed by medical history; Patient that is taking any prohibited medication (Item 9.3); Participation in last one year of clinical protocols, unless it can be direct benefit to subject; Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 01<br>ACH24 | Drug: Group 01<br>* ACH24<br>* Other names: ACH24;|
| Placebo Comparator: Group 02<br>Placebo | Drug: Group 02<br>* Placebo<br>* Other names: PLACEBO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repigmentation of the affected area assessed by VASI (vitiligo area scoring index). | 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). | Baseline compared to the end of 18 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire | Dermatology Life Quality Index (DLQI) | 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. | Collection of safety data throughout the whole study period | Will be evaluated during whole study, at the baseline and after 18 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo, Macular depigmentation, Stachytarpheta cayensensis