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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

Page last updated: August 23, 2015

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