ClinicalTrials.gov
ClinicalTrials.gov Menu

Melanil in the Treatment of Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01001624
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : May 4, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melasma Other: Melanil facial cream Other: Hydroquinone 2% cream Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Melanil in the Treatment of Melasma
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Measures :
  1. Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52. [ Time Frame: 52 weeks ]
  2. Photographs, at the beginning of the study and at weeks 8, 12 and 52. [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01001624     History of Changes
Other Study ID Numbers: CAT-0914-CU
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Catalysis SL:
Cosmetic
Facial cream
Melasma
Melanil

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