Melanil in the Treatment of Melasma

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Melasma

Treatments: Other: Hydroquinone 2% cream; Other: Melanil facial cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001624

CAT-0914-CU

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

A

Experimental group

Description:

Melanil facial cream

Treatment:

Other: Melanil facial cream

B

Active Comparator group

Description:

Hydroquinone 2% cream

Treatment:

Other: Hydroquinone 2% cream