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OpenTrials
Completed

NCT Number: NCT01001624

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melanil facial cream

Other

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.

Hydroquinone 2% cream

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Efficacy of Melanil in the Treatment of Melasma

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2009
Registry last updated
May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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