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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroquinone | Drug |
| ||
| Placebo |
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess patients' satisfaction regarding Melanoderm 4% Crema. | 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. | Week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susana Puig, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| C031927 | hydroquinone |
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