Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study

Phase 2

Completed

• Conditions: Melasma
• Interventions: Drug: Eflornithine hydrochloride cream; Drug: Hydroquinone cream

• Registration Number: NCT06957834
• Lead Sponsor: National Skin Centre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-06
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-05
• Last Update Posted: 2025-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face	Eflornithine hydrochloride cream	-
Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face	Hydroquinone cream	-
Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face	Eflornithine hydrochloride cream	-
Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face	Hydroquinone cream	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Mexameter erythema score	At 8 and 12 weeks	Mexameter device (Courage + Khazaka Electronic GmbH, Germany)

Trial Locations

Locations (1)

National Skin Centre; 🇸🇬 Singapore, Singapore