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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Facial Melasma

Intervention / Treatment
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* Drug: Hydroquinone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroquinone<br>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<br> <br> |
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Facial Melasma