Clinical trial NCT01419964: Efficacy and Safety of ACH24 in the Treatment of Vitiligo
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Vitiligo
Keywords: Vitiligo
Macular depigmentation
Stachytarpheta cayensensis
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
timeFrame: Baseline compared to the end of 18 months of treatment
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)
measure: Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
timeFrame: Will be evaluated during whole study, at the baseline and after 18 months of treatment
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Curitiba
state: Paraná
Study officials:
affiliation: PUNTIFÍCIA UNIVERSIDADE CATÓLICA
name: CAIO CASTRO, PHYSICIAN
role: PRINCIPAL_INVESTIGATOR
References: