Efficacy and Safety of ACH24 in the Treatment of Vitiligo

NCT ID: NCT01419964

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31

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.

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 01

ACH24

Group Type: EXPERIMENTAL

Group 01

Intervention Type: DRUG

ACH24

Group 02

Placebo

Group Type: PLACEBO_COMPARATOR

Group 02

Intervention Type: DRUG

Placebo

Interventions

Group 01

ACH24

Intervention Type: DRUG

Group 02

Placebo

Intervention Type: DRUG

Other Intervention Names

ACH24; PLACEBO

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CAIO CASTRO, PHYSICIAN

Role: PRINCIPAL_INVESTIGATOR

PUNTIFÍCIA UNIVERSIDADE CATÓLICA

Locations

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, Brazil

Countries

Brazil

Other Identifiers

ACH-VTL-03(09/11)

Identifier Type: -

Identifier Source: org_study_id