Melanil in the Treatment of Melasma

Phase 3

Completed

• Conditions: Melasma
• Interventions: Other: Melanil facial cream; Other: Hydroquinone 2% cream

• Registration Number: NCT01001624
• Lead Sponsor: Catalysis SL

Brief Summary

The purpose of the study is to assess the efficacy of Melanil facial cream in the treatment of melasma. The duration of this double-blind phase 3 clinical trial will be 54 weeks. The control group will receive treatment with Hydroquinone (2%). The estimated number of subjects to be recruited and randomized for the study is 150. The primary outcome measure: Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, 12 and 54. Photographs taken at the beginning of the study and at weeks 8, 12 and 54 will be evaluated by two independent dermatologists. Occurrence of adverse effects will also be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Clinical diagnosis of Melasma
• Fitzpatrick's skin types I to IV
• Signed informed consent
• Given verbal agreement on protection from UV light during treatment by the usage of physical barriers (umbrellas, caps, hats, etc).

Exclusion Criteria

• Fitzpatrick's skin types V and VI
• Treatment with steroids within the duration of the clinical trial.
• Oral contraception within the duration of the clinical trial
• Usage of other cosmetics within the duration of the clinical trial
• Treatment with Clofazimine within the duration of the clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Melanil facial cream	Melanil facial cream
B	Hydroquinone 2% cream	Hydroquinone 2% cream

Primary Outcome Measures

Name	Time	Method
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.	52 weeks

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.	52 weeks
Photographs, at the beginning of the study and at weeks 8, 12 and 52.	52 weeks

Trial Locations

Locations (1)

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital; 🇨🇺 Havana City, Havana, Cuba