- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01001624
Melanil in the Treatment of Melasma
May 2, 2012 updated by: Catalysis SL
Efficacy of Melanil in the Treatment of Melasma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Havana
-
Havana City, Havana, Cuba, 10400
- "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Melanil facial cream
|
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.
|
Active Comparator: B
Hydroquinone 2% cream
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.
Time Frame: 52 weeks
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.
Time Frame: 52 weeks
|
52 weeks
|
Photographs, at the beginning of the study and at weeks 8, 12 and 52.
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alfredo Abreu Daniel, PhD, "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
October 23, 2009
First Submitted That Met QC Criteria
October 23, 2009
First Posted (Estimate)
October 26, 2009
Study Record Updates
Last Update Posted (Estimate)
May 4, 2012
Last Update Submitted That Met QC Criteria
May 2, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAT-0914-CU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melasma
-
Mesoestetic Pharma Group S.L.Completed
-
ConBio, a Cynosure CompanyCompleted
-
University of Nove de JulhoRecruiting
-
Jinnah Postgraduate Medical CentreActive, not recruiting
-
China Medical University HospitalCompleted
-
VIST - Faculty of Applied SciencesActive, not recruiting
-
China Medical University HospitalApollo Medical Optics, LtdCompleted
-
Combined Military Hospital AbbottabadCompleted
-
Northwestern UniversityCompleted
-
Centre Hospitalier Universitaire de NiceCompleted
Clinical Trials on Melanil facial cream
-
Integrative Skin Science and ResearchArbonneActive, not recruiting
-
Facial Concepts, Inc.CompletedSleep Apnea | Primary SnoringUnited States
-
Universiti Sains MalaysiaMalaysia Palm Oil Board; Avantsar Sdn. Bhd.Terminated
-
Kasr El Aini HospitalRecruiting
-
San Diego State UniversityCompletedSkin Cancer | Basal Cell Carcinoma | Squamous Cell Carcinoma | Skin Cancer MelanomaUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownBlepharospasm
-
Brigham and Women's HospitalUnited States Department of DefenseCompleted
-
AllerganCompleted
-
Assistance Publique Hopitaux De MarseilleUnknownQuality of Life | Peripheral Facial ParalysisFrance
-
Indonesia UniversityCompleted