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The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face | Active Comparator |
| |
| Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eflornithine hydrochloride cream | Drug | Eflornithine hydrochloride cream at 11.5% applied twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Melasma Area and Severity Index (mMASI) | At 8 weeks and 12 weeks | |
| Mexameter melanin score | Mexameter device (Courage + Khazaka Electronic GmbH, Germany) | At 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mexameter erythema score | Mexameter device (Courage + Khazaka Electronic GmbH, Germany) | At 8 and 12 weeks |
| Patient Satisfaction Score | For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Skin Centre | Singapore | Singapore |
all IPD that underlie results in publication
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Beginning 6 months and ending 2 years after publication
Upon reasonable request to corresponding author
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.
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| Hydroquinone cream | Drug | Hydroquinone 2% cream, applied twice daily |
|
| At 8 and 12 weeks |
| Physician Global Assessment | For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe) | At 8 and 12 weeks |