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

Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study

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 Overview

• Status: Completed
• Conditions: Facial Melasma
• Intervention / Treatment: Drug: Placebo; Drug: Hydroquinone

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroquinone; Hydroquinone 4% Cream will be applied in one side of the face while the other side of the face receives placebo. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks.	Drug: Hydroquinone
Placebo Comparator: Placebo; Placebo cream (vehicle of Hydroquinone 4% cream), will be applied in one side of the face, while the other side receives the active treatment. Half of the patients will receive Hydroquinone on the right side of the face and the other half on the left side. It will be applied daily, at night, during 8 weeks.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, week 4, week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4, Week 8, Follow-up period (Week 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess patients' satisfaction regarding Melanoderm 4% Crema.	Patients' satisfaction in terms of efficacy and safety will be evaluated by a Visual Analogic Scale at week 8, which will be completed for each side of the face independently.	Week 8

Collaborators and Investigators

• Sponsor: Mesoestetic Pharma Group S.L.
• Investigators: Principal Investigator: Susana Puig, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Facial Melasma
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Radiation-Protective Agents; Hydroquinone
• Other Study ID Numbers: ECM2013