Melasma
Conditions
Keywords
Melasma, Dermatology, Eflornithine
Brief summary
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: * Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream? * What side effects might patients get while using Eflornithine hydrochloride cream? Participants will: * Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months. * Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.
Interventions
DRUGEflornithine hydrochloride cream
Eflornithine hydrochloride cream at 11.5% applied twice daily
Hydroquinone 2% cream, applied twice daily
Sponsors
National Skin Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of melasma * Fitzpatrick Type III or IV * Able to provide informed consent
Exclusion criteria
* Pregnant or lactating patients * Patients with difficulty adhering to regular topical treatments * Patients with known contact allergies to any of the ingredients in the topical medications used in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Melasma Area and Severity Index (mMASI) | At 8 weeks and 12 weeks | — |
| Mexameter melanin score | At 8 and 12 weeks | Mexameter device (Courage + Khazaka Electronic GmbH, Germany) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mexameter erythema score | At 8 and 12 weeks | Mexameter device (Courage + Khazaka Electronic GmbH, Germany) |
| Patient Satisfaction Score | At 8 and 12 weeks | 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) |
| Physician Global Assessment | At 8 and 12 weeks | 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) |
Countries
Singapore
Outcome results
None listed