Efficacy and Safety of a 4% Hydroquinone Cream for the Treatment of Melasma

Phase 3CompletedNCT02095990

Mesoestetic Pharma Group S.L.17 enrolled

Overview

To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face, using a split-face randomization design, evaluating the MASI Score from baseline to week 4 and week 8, in both half-faces receiving active treatment vs. placebo. To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face. To assess patients' satisfaction regarding Melanoderm 4% Crema after 8 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Facial Melasma

Interventions

HydroquinoneDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult women aged between 18-65 years old. * Fitzpatrick phototypes I to IV. * Presenting moderate to severe facial melasma facial, with a basal Melasma Area and Severity Index (MASI Index) between 10 and 20. * Women of childbearing potential must use an adequate 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. 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 procedures. * Participation in other clinical trial simultaneously or in the previous 3 months.

Locations (1)

Hospital Clinic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.

Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).

Time frame: Baseline, week 4, week 8.

Secondary Outcomes

To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.

Adverse events will be recorded throughout the study and 30 days after the end of treatment.

Time frame: Week 4, Week 8, Follow-up period (Week 12)

Data from ClinicalTrials.gov

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