A Phase 2 interventional study of Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream and Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream in Melasma and Melasma (Facial Melasma), sponsored by National Skin Centre. Completed at 1 site in Singapore. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by National Skin Centre · Phase 2, Interventional, and Treatment
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.
159 studies on the registry are indexed under Melanosis; 42 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 149 interventional studies indexed under Melanosis.
Browse Melanosis studies →National Skin Centre is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Every subject receives both interventions at the same time, just on different randomized sides of the face. Each subject will be randomized to apply eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% cream to one side of face and tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream on the other side. The study creams will be packaged in identical containers so that the identity of the cream is not known. Subjects and outcomes assessors were blinded to the treatment allocations.
Drug: Eflornithine 9.58% + Hydroquinone 4% + Fluocinolone 0.01% cream · Drug: Tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01% cream
Drug page: Eflornithine
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 page: Tretinoin
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.
modified Melasma Area and Severity Index (mMASI) score
Calculated by assessing the area of involvement and the darkness of melasma across four facial regions. It yields a total score from 0 (clear) to 24 (severe)
Time frame: From enrolment to the end of treatment at 12 weeks
Change from baseline in Melanin Index (M) measured using the SkinColorCatch®
Melanin Index (M) will be measured objectively using the SkinColorCatch® colorimeter on each side of the face. The change in Melanin Index from baseline to month 3 will be calculated for each treatment side. The change from baseline will be compared between the side treated with eflornithine 9.58% + hydroquinone 4% + fluocinolone 0.01% and the side treated with tretinoin 0.05% + hydroquinone 4% + fluocinolone 0.01%. Lower Melanin Index values indicate lower skin pigmentation.
Time frame: From enrolment to the end of treatment at 12 weeks
Physician Global Assessment
Obtained through a clinician's visual evaluation of the patient's facial hyperpigmentation, grading the overall severity on a standardized scale
Time frame: From enrolment to the end of treatment at 12 weeks
Patient Global Assessment
Obtained through patient's visual evaluation of their facial hyperpigmentation, grading the overall severity on a standardized scale
Time frame: From enrolment to the end of treatment at 12 weeks
Adverse events (AEs) and serious adverse events (SAEs)
AE include contact dermatitis, SAE include severe allergy reactions with contact dermatitis with secondary spread and lymph node enlargement, ochronosis and skin atrophy.
Time frame: From enrolment to the end of treatment at 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2023 to primary completion in Jul 2024, 13 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Eflornithine · Tretinoin
National Skin Centre