Efficacy and Safety of ACH24 in the Treatment of Vitiligo

This study has been withdrawn prior to enrollment.

(The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.)

Sponsor:

Information provided by (Responsible Party):

Ache Laboratorios Farmaceuticos S.A.

ClinicalTrials.gov Identifier:

NCT01419964

First received: August 17, 2011

Last updated: March 15, 2016

Last verified: March 2016

History of Changes

Purpose

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	Intervention	Phase
Vitiligo	Drug: Group 01 Drug: Group 02	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: vitiligo

MedlinePlus related topics: Vitiligo

Genetic and Rare Diseases Information Center resources: Hypomelanotic Disorder

U.S. FDA Resources

Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:

Repigmentation of the affected area assessed by VASI (vitiligo area scoring index). [ Time Frame: Baseline compared to the end of 18 months of treatment ] [ Designated as safety issue: No ]
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:

Quality of life questionnaire [ Time Frame: Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18) ] [ Designated as safety issue: No ]
Dermatology Life Quality Index (DLQI)
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 ] [ Designated as safety issue: Yes ]
Collection of safety data throughout the whole study period


Enrollment:	0
Study Start Date:	January 2012
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 01 ACH24	Drug: Group 01 ACH24 Other Name: ACH24
Placebo Comparator: Group 02 Placebo	Drug: Group 02 Placebo Other Name: PLACEBO

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


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419964

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


Responsible Party:	Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:	NCT01419964 History of Changes
Other Study ID Numbers:	ACH-VTL-03(09/11)
Study First Received:	August 17, 2011
Last Updated:	March 15, 2016
Health Authority:	Brazil: Ethics Committee Brazil: Ministry of Health

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:


Vitiligo Macular depigmentation Stachytarpheta cayensensis

Additional relevant MeSH terms:


Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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