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Melanil in the Treatment of Melasma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT01001624
First received: October 23, 2009
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Melasma
 Other: Melanil facial cream
Other: Hydroquinone 2% cream
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Melanil in the Treatment of Melasma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Photographs, at the beginning of the study and at weeks 8, 12 and 52. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Melanil facial cream
 Other: 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
 Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001624

Locations
Cuba
"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
Havana City, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Alfredo Abreu Daniel, PhD "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
  More Information

No publications provided

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01001624     History of Changes
Other Study ID Numbers: CAT-0914-CU
Study First Received: October 23, 2009
Last Updated: May 2, 2012
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Cosmetic
Facial cream
Melasma
Melanil

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
Radiation-Protective Agents
 Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013