Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
Information source: Mesoestetic Pharma Group S.L.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Facial Melasma
Intervention: Hydroquinone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Mesoestetic Pharma Group S.L. Official(s) and/or principal investigator(s): Susana Puig, MD, Principal Investigator, Affiliation: Hospital Clinic de Barcelona
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.
Clinical Details
Official title: Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face.
Secondary outcome: To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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 and Contacts
Hospital Clinic de Barcelona, Barcelona 08036, Spain
Additional Information
Starting date: March 2014
Last updated: April 9, 2015
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