We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melanil in the Treatment of Melasma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001624
First Posted: October 26, 2009
Last Update Posted: May 4, 2012
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.
Information provided by (Responsible Party):
Catalysis SL
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Melanil in the Treatment of Melasma

Resource links provided by NLM:


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 ]

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

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

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
  Contacts and Locations
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
  More Information

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01001624     History of Changes
Other Study ID Numbers: CAT-0914-CU
First Submitted: October 23, 2009
First Posted: October 26, 2009
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