Back to resultsMelanil in the Treatment of Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Melanil facial cream
Hydroquinone 2% cream
Sponsored by
About this trial
This is an interventional treatment trial for Melasma focused on measuring Cosmetic, Facial cream, Melasma, Melanil
Eligibility Criteria
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
Sites / Locations
- "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Melanil facial cream
Hydroquinone 2% cream
Outcomes
Primary Outcome Measures
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Secondary Outcome Measures
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01001624
Brief Title
Melanil in the Treatment of Melasma
Official Title
Efficacy of Melanil in the Treatment of Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Cosmetic, Facial cream, Melasma, Melanil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Melanil facial cream
Arm Title
B
Arm Type
Active Comparator
Arm Description
Hydroquinone 2% cream
Intervention Type
Other
Intervention Name(s)
Melanil facial cream
Intervention Description
Dosage commensurate with surface to be treated, Melanil facial cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Melanil facial cream.
Intervention Type
Other
Intervention Name(s)
Hydroquinone 2% cream
Intervention Description
Dosage commensurate with surface to be treated, Hydroquinone 2% cream (Topical use), twice a day, for 8 weeks. The affected surface will be washed and dried before application with a thin layer of Hydroquinone 2% cream.
Primary Outcome Measure Information:
Title
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Time Frame
52 weeks
Title
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfredo Abreu Daniel, PhD
Organizational Affiliation
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
City
Havana City
State/Province
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Learn more about this trial
Melanil in the Treatment of Melasma
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