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

NCT06957834 | Completed Phase 2

• 1 other identifier: 2019/00399
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Keywords

Melasma; Dermatology; Eflornithine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Mexameter erythema score

  At 8 and 12 weeks

• Patient Satisfaction Score

  At 8 and 12 weeks

• Physician Global Assessment

  At 8 and 12 weeks

Study Arms (2)

Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face

ACTIVE COMPARATOR

Drug: Eflornithine hydrochloride cream; Drug: Hydroquinone cream

Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face

ACTIVE COMPARATOR

Drug: Eflornithine hydrochloride cream; Drug: Hydroquinone cream

Interventions

Eflornithine hydrochloride cream DRUG

Eflornithine hydrochloride cream at 11.5% applied twice daily

Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face; Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face

Hydroquinone cream DRUG

Hydroquinone 2% cream, applied twice daily

Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face; Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of melasma
• Fitzpatrick Type III or IV
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Skin Centre: lead

Study Sites (1)

National Skin Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director and Senior Consultant

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 5, 2025
• Study Start: June 6, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: May 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months and ending 2 years after publication
• Access Criteria: Upon reasonable request to corresponding author

Locations

SG (1)