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Efficacy and Safety of ACH24 in the Treatment of Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419964
Recruitment Status : Withdrawn (The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.)
First Posted : August 19, 2011
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: Group 01
Drug: Group 01
Other Name: ACH24

Placebo Comparator: Group 02
Drug: Group 02
Other Name: PLACEBO

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

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419964

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Irmandade da Santa Casa de Misericórdia de Curitiba
Curitiba, Paraná, Brazil, 80010-030
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
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Responsible Party: Ache Laboratorios Farmaceuticos S.A. Identifier: NCT01419964    
Other Study ID Numbers: ACH-VTL-03(09/11)
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Macular depigmentation
Stachytarpheta cayensensis
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases