Phase 2Completed
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 (Research network)
- Enrolment
- 30 enrolled
- Conditions
- Melasma; Melasma (Facial Melasma)
- Interventions
- Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream; Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream
- Ages
- adults, older adults
- Registry
- NCT07876323
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- modified Melasma Area and Severity Index (mMASI) score
- Change from baseline in Melanin Index (M) measured using the SkinColorCatch®
- Physician Global Assessment
- Patient Global Assessment
History
Registered
Primary completion
Started