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Efficacy and Safety of ACH24 in the Treatment of Vitiligo

Primary Purpose

Vitiligo

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Group 01
Group 02
Sponsored by
Ache Laboratorios Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Macular depigmentation, Stachytarpheta cayensensis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Irmandade da Santa Casa de Misericórdia de Curitiba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 01

Group 02

Arm Description

ACH24

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Quality of life questionnaire
Dermatology Life Quality Index (DLQI)
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Collection of safety data throughout the whole study period

Full Information

First Posted
August 17, 2011
Last Updated
March 15, 2016
Sponsor
Ache Laboratorios Farmaceuticos S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01419964
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ache Laboratorios Farmaceuticos S.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, Macular depigmentation, Stachytarpheta cayensensis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 01
Arm Type
Experimental
Arm Description
ACH24
Arm Title
Group 02
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Group 01
Other Intervention Name(s)
ACH24
Intervention Description
ACH24
Intervention Type
Drug
Intervention Name(s)
Group 02
Other Intervention Name(s)
PLACEBO
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
Description
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).
Time Frame
Baseline compared to the end of 18 months of treatment
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
Dermatology Life Quality Index (DLQI)
Time Frame
Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)
Title
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Description
Collection of safety data throughout the whole study period
Time Frame
Will be evaluated during whole study, at the baseline and after 18 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAIO CASTRO, PHYSICIAN
Organizational Affiliation
PUNTIFÍCIA UNIVERSIDADE CATÓLICA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irmandade da Santa Casa de Misericórdia de Curitiba
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80010-030
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of ACH24 in the Treatment of Vitiligo

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