Efficacy and Safety of ACH24 in the Treatment of Vitiligo

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01419964
• Other study ID #: ACH-VTL-03(09/11)
• Status: Withdrawn
• Phase: Phase 3
• First received: August 17, 2011
• Last updated: March 15, 2016
• Start date: January 2012

Study information

• Verified date: March 2016
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Group 01
ACH24
• Group 02
Placebo

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa de Misericórdia de Curitiba	Curitiba	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of life questionnaire	Dermatology Life Quality Index (DLQI)	Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)	No
Secondary	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	Yes