Melanil in the Treatment of Melasma

Efficacy of Melanil in the Treatment of Melasma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01001624

Enrollment

150

Registered

2009-10-26

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

Cosmetic, Facial cream, Melasma, Melanil

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.

Interventions

OTHERMelanil 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.

OTHERHydroquinone 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026