Efficacy and Safety of ACH24 in the Treatment of Vitiligo

March 15, 2016 updated by: Ache Laboratorios Farmaceuticos S.A.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80010-030
        • Irmandade da Santa Casa de Misericordia de Curitiba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 01
ACH24
Drug: Group 01
ACH24
Other Names:
  • ACH24
Placebo Comparator: Group 02
Placebo
Drug: Group 02
Placebo
Other Names:
  • PLACEBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline compared to the end of 18 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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
Will be evaluated during whole study, at the baseline and after 18 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Investigators

  • Principal Investigator: CAIO CASTRO, PHYSICIAN, PUNTIFÍCIA UNIVERSIDADE CATÓLICA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACH-VTL-03(09/11)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitiligo

Clinical Trials on Group 01

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe