Melanil in the Treatment of Melasma

Melasma Clinical Trial

Official title:

Efficacy of Melanil in the Treatment of Melasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001624
• Other study ID #: CAT-0914-CU
• Status: Completed
• Phase: Phase 3
• First received: October 23, 2009
• Last updated: May 2, 2012
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melasma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Cuba	"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.		52 weeks	No
Secondary	Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.		52 weeks	Yes
Secondary	Photographs, at the beginning of the study and at weeks 8, 12 and 52.		52 weeks	No