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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

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ClinicalTrials.gov Identifier: NCT02095990
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Mesoestetic Pharma Group S.L.

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.


Condition or disease Intervention/treatment Phase
Facial Melasma Drug: Hydroquinone Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a 4% Hydroquinone Cream (Melanoderm 4%) for the Treatment of Melasma: a Randomized Controlled Split-face Study
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. To assess the ability of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) to reduce melasma on the face. [ Time Frame: Baseline, week 4, week 8. ]
    Efficacy assessments will be measured by the Melasma Area and Severity Index (MASI Index) at baseline, week 4 and week 8 (end of treatment).


Secondary Outcome Measures :
  1. To assess the tolerance of a new 4% Hydroquinone formulation (Melanoderm 4% Crema) on the face. [ Time Frame: Week 4, Week 8, Follow-up period (Week 12) ]
    Adverse events will be recorded throughout the study and 30 days after the end of treatment.


Other Outcome Measures:
  1. To assess patients' satisfaction regarding Melanoderm 4% Crema. [ Time Frame: Week 8 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095990


Locations
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Mesoestetic Pharma Group S.L.
Investigators
Principal Investigator: Susana Puig, MD Hospital Clinic of Barcelona

Responsible Party: Mesoestetic Pharma Group S.L.
ClinicalTrials.gov Identifier: NCT02095990     History of Changes
Other Study ID Numbers: ECM2013
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Mesoestetic Pharma Group S.L.:
Facial Melasma

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Hydroquinone
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents