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COMPLETED
NCT07876323
PHASE2

Randomized Split-Face Controlled Study to Evaluate the Effectiveness of Topical Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% as Compared to Topical Tretinoin 0.05% + Hydroquinone 4% + Fluocinolone 0.01% for the Treatment of Melasma

Sponsor: National Skin Centre

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether a new combination cream containing eflornithine, hydroquinone, and fluocinolone works better and causes fewer side effects than Tri-Luma® (tretinoin, hydroquinone, and fluocinolone), a commonly used treatment for melasma. The main question is whether replacing tretinoin in Tri-Luma® with eflornithine leads to greater improvement in melasma and less skin irritation over a 12-week period.

Key Details

Gender

All

Age Range

25 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-06-06

Completion Date

2024-07-11

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream

Each subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face.

DRUG

Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream

Each subject receives both interventions ( eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream) simultaneously, one on each randomized side of the face.

Locations (1)

National Skin Centre

Singapore, Singapore, Singapore