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

NCT02095990 | Completed Phase 3

• 1 other identifier: ECM2013
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Melasma

Keywords

Facial Melasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Week 4, Week 8, Follow-up period (Week 12)

Other Outcomes (1)

• To assess patients' satisfaction regarding Melanoderm 4% Crema.

  Week 8

Study Arms (2)

Hydroquinone

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Hydroquinone DRUG

Hydroquinone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

hydroquinone

Study Officials

• Susana Puig, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 26, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 30, 2019

Record last verified: 2015-04

Locations

ES (1)