TRI-LUMA (fluocinolone acetonide)
TRI-LUMA Cream is a triple-combination product containing fluocinolone acetonide (corticosteroid), hydroquinone (melanin synthesis inhibitor), and tretinoin (retinoid). It is indicated for the short-term treatment of moderate to severe melasma of the face and must be used in conjunction with sun avoidance measures, such as sunscreen. It is not indicated for maintenance therapy, as melasma typically recurs after treatment is discontinued. Safety and efficacy have not been established in patients with Fitzpatrick Skin Types V and VI, or in pregnant and nursing women.
How TRI-LUMA Works
The exact mechanism of action of the active ingredients in TRI-LUMA Cream for the treatment of melasma is unknown. The formulation combines the anti-inflammatory effects of a corticosteroid (fluocinolone acetonide), the depigmenting effects of a melanin synthesis inhibitor (hydroquinone), and the keratolytic effects of a retinoid (tretinoin).
Details
- Status
- Prescription
- First Approved
- 2002-01-18
- Routes
- TOPICAL
- Dosage Forms
- CREAM
Companies
TRI-LUMA Approval History
What TRI-LUMA Treats
1 indicationsTRI-LUMA is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melasma
GALDERMA LABS LP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05844982 AL | Protocol AL UG1EY014231 | Ph 3 | recruiting | Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy |
| NCT01781936 Iluvien | Pro00033019 | Ph 1 | completed | Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis |
| NCT00695318 results posted | C-01-08-004 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy |
| NCT00770770 FAVOR results posted | C-01-08-006 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina |
| NCT01304706 results posted | C-01-11-008 | Ph 3 | completed | Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRI-LUMA FDA Label Details
Indications & Usage
FDA Label (PDF)TRI-LUMA is indicated for the treatment of Melasma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.