Efficacy and Safety of ACH24 in the Treatment of Vitiligo
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ClinicalTrials.gov 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Withdrawn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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitiligo | Drug: Group 01 Drug: Group 02 | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 01
ACH24
|
Drug: Group 01
ACH24
Other Name: ACH24
|
Placebo Comparator: Group 02
Placebo
|
Drug: Group 02
Placebo
Other Name: PLACEBO
|
- 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).
- 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)
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (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.

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 ClinicalTrials.gov identifier (NCT number): NCT01419964
Brazil | |
Irmandade da Santa Casa de Misericórdia de Curitiba | |
Curitiba, Paraná, Brazil, 80010-030 |
Principal Investigator: | CAIO CASTRO, PHYSICIAN | PUNTIFÍCIA UNIVERSIDADE CATÓLICA |
Responsible Party: | Ache Laboratorios Farmaceuticos S.A. |
ClinicalTrials.gov Identifier: | NCT01419964 History of Changes |
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.:
Vitiligo Macular depigmentation Stachytarpheta cayensensis |
Additional relevant MeSH terms:
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |