Efficacy and Safety of ACH24 in the Treatment of Vitiligo

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Vitiligo	Drug: Group 01; Drug: Group 02	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Study Start Date :	January 2012
Estimated Primary Completion Date :	December 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Group 01; ACH24	Drug: Group 01; ACH24; Other Name: ACH24
Placebo Comparator: Group 02; Placebo	Drug: Group 02; Placebo; Other Name: PLACEBO

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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)
2. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Ache Laboratorios Farmaceuticos S.A.

Investigators

Principal Investigator:	CAIO CASTRO, PHYSICIAN	PUNTIFÍCIA UNIVERSIDADE CATÓLICA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:	NCT01419964 History of Changes
Other Study ID Numbers:	ACH-VTL-03(09/11)
First Posted:	August 19, 2011
Last Update Posted:	March 16, 2016
Last Verified:	March 2016

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:

Vitiligo; Macular depigmentation; Stachytarpheta cayensensis

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases