NCT01419964

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

August 17, 2011

Last Update Submit

March 15, 2016

Conditions

Vitiligo

Keywords

VitiligoMacular depigmentationStachytarpheta cayensensis

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline compared to the end of 18 months of treatment

Secondary Outcomes (2)

  • Quality of life questionnaire

    Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)

  • Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.

    Will be evaluated during whole study, at the baseline and after 18 months of treatment

Study Arms (2)

Group 01

EXPERIMENTAL

ACH24

Drug: Group 01

Group 02

PLACEBO COMPARATOR

Placebo

Drug: Group 02

Interventions

Group 01DRUG

ACH24

Also known as: ACH24
Group 01
Group 02DRUG

Placebo

Also known as: PLACEBO
Group 02

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, 80010-030, Brazil

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • CAIO CASTRO, PHYSICIAN

    PUNTIFÍCIA UNIVERSIDADE CATÓLICA

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 19, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

BR(1)