CLOBEX (clobetasol propionate)
Clobex (clobetasol propionate) Lotion, 0.05%, is a super-high potency topical corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. Treatment is typically limited to two consecutive weeks. For localized moderate to severe plaque psoriasis (less than 10% body surface area), treatment may be extended for an additional two weeks if initial results are insufficient. Due to the risk of HPA axis suppression and skin atrophy, it should not be used on the face, axillae (armpits), or groin, nor should it be used to treat rosacea or perioral dermatitis. Total dosage should not exceed 50 g/week.
How CLOBEX Works
Clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. While the exact mechanism of its anti-inflammatory activity is not fully established, it is thought to act by inducing phospholipase A2 inhibitory proteins, collectively known as lipocortins. These proteins are postulated to control the biosynthesis of potent inflammatory mediators, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid, from cell membranes.
Details
- Status
- Prescription
- First Approved
- 2003-07-24
- Routes
- TOPICAL
- Dosage Forms
- LOTION, SPRAY, SHAMPOO
CLOBEX Approval History
What CLOBEX Treats
4 indicationsCLOBEX is approved for 4 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
- Plaque Psoriasis
- Rosacea
- Perioral Dermatitis
CLOBEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02368886 results posted | RU021407I NCI-2015-00011, RU021407I | Ph 2 | completed | Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer |
| NCT05364515 PRGF | BTIIMD-01-EC/217LIQUEN | Ph 3 | withdrawn | Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva |
| NCT04364555 | LIKLO-1 | Ph 2, Ph 3 | active not recruiting | Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus. |
| NCT05724446 CLOSE-3 | CLOBOF3-17IA03 | Ph 3 | recruiting | Clobetasol Propionate Ophthalmic Nanoemulsion, 0.05% in the Treatment of Inflammation After Cataract Surgery in Pediatric Population |
| NCT04246801 CLOSE-1 results posted | CLOBOF3-16IA01 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1) |
| NCT04249076 CLOSE-2 results posted | CLOBOF3-16IA02 | Ph 3 | completed | Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2) |
| NCT03592342 | DT-001-R-004 | Ph 2 | completed | Intra-oral Treatment of OLP With Rivelin®-CLO Patches |
| NCT03535233 | AA22 | Ph 4 | completed | Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata |
| NCT02936492 | 17014 | Ph 1 | terminated | BAY1003803 Single and Multiple Dose Escalation, Safety, Tolerability and Pharmacokinetics Study |
| NCT01381445 | 113435 | Ph 1 | completed | A Study Assessing GW870086's Potential to Cause Skin Thinning |
| NCT02940002 | 17012 2016-000962-47 | Ph 1 | completed | BAY1003803 Formulation Comparison in Open Psoriasis Plaque Test |
| NCT00828464 results posted | U0280-401 | Ph 4 | completed | Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis |
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.
CLOBEX FDA Label Details
Indications & Usage
FDA Label (PDF)CLOBEX is indicated for the treatment of Dermatoses; Plaque Psoriasis; Rosacea; Perioral Dermatitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.