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

Facial Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095990
• Other study ID #: ECM2013
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Mesoestetic Pharma Group S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Melasma
• Melanosis

Intervention

Drug:
• Hydroquinone

• Placebo

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Mesoestetic Pharma Group S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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)