DERMA-SMOOTHE/FS (fluocinolone acetonide)
Derma-Smoothe/FS is a topical oil used for adults who have psoriasis affecting the scalp. As a corticosteroid, it helps manage this chronic skin condition by addressing the underlying symptoms. It is specifically formulated for application to the scalp to provide relief for patients dealing with these localized flare-ups.
How DERMA-SMOOTHE/FS Works
This medication works by influencing cellular signaling, immune function, and protein regulation within the body. While the exact process for how it addresses scalp psoriasis is not fully known, it plays a role in managing inflammation.
Details
- Status
- Prescription
- First Approved
- 1988-02-03
- Routes
- TOPICAL
- Dosage Forms
- OIL
DERMA-SMOOTHE/FS Approval History
What DERMA-SMOOTHE/FS Treats
1 indicationsDERMA-SMOOTHE/FS is approved for 1 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Psoriasis
DERMA-SMOOTHE/FS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
DERMA-SMOOTHE/FS FDA Label Details
Indications & Usage
FDA Label (PDF)DERMA-SMOOTHE/FS is indicated for the treatment of Psoriasis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.