Efficacy and safety of a 4% hydroquinone cream (Melanoderm 4%) for the treatment of melasma.

• Conditions: Facial melasma; MedDRA version: 16.1Level: LLTClassification code 10027161Term: MelasmaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-003501-25-ES
• Lead Sponsor: Mesoestetic Pharma group S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-12
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Adult women aged between 18-75 years old.
Fitzpatrick phototypes I to IV.
Presenting noderate to severe facial melasma facial, with a basal MASI Index between 10 and 20.
Women of childbearing potential must use an adecuate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
Breastfeeding women will not be included in the study.
Having given freely and expressly her informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
Fitzpatrick phototype V.
Skin pigmentation diseases different to melasma.
Evidence of active cancer disease or diagnosis of cancer in the last year.
Those receiving any topical or oral treatment that could interfere with melasma.
Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
Evidence or suspicion of low compliance with the study visits and proecedures.
Participation in other clinical trial simultaneously or in the previous 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified