Efficacy and Safety of ACH24 in the Treatment of Vitiligo (NCT01419964) | Clinical Trial Compass
WithdrawnPhase 3
Efficacy and Safety of ACH24 in the Treatment of Vitiligo
Stopped: The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.
Brazil0Started 2012-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
Timeframe: Baseline compared to the end of 18 months of treatment