Melanil in the Treatment of Melasma

NCT01001624 | Completed Phase 3 DMC

• 1 other identifier: CAT-0914-CU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

Cosmetic; Facial cream; Melasma; Melanil

Outcome Measures

Primary Outcomes (1)

• MASI score, at the beginning of the study and at weeks 4, 8 (end of the treatment), 12 and 52.

  52 weeks

Secondary Outcomes (2)

• Occurrence of adverse effects within the 8 week treatment period and at weeks 12,24 and 52.

  52 weeks

• Photographs, at the beginning of the study and at weeks 8, 12 and 52.

  52 weeks

Study Arms (2)

A

EXPERIMENTAL

Melanil facial cream

Other: Melanil facial cream

B

ACTIVE COMPARATOR

Hydroquinone 2% cream

Other: Hydroquinone 2% cream

Interventions

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.

A

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.

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

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

Havana, La Habana, 10400, Cuba

Location

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alfredo Abreu Daniel, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 4, 2012

Record last verified: 2012-05

Locations

CU (1)