Overview
Clobetasol propionate is a prednisolone derivative with higher specificity for glucocorticoid receptors than mineralocorticoid receptors. It has demonstrated superior activity compared to fluocinonide and was first described in the literature in 1974. Clobetasol Propionate was granted FDA approval on 27 December 1985.
Indication
Clobetasol propionate is indicated to treat moderate to severe plaque psoriasis as well as inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Associated Conditions
- Alopecia
- Severe Plaque psoriasis
- Corticosteroid responsive, Inflammatory Dermatosis
- Corticosteroid responsive, pruritic Dermatosis
- Moderate Plaque psoriasis
- Moderate Scalp Psoriasis
- Severe Scalp Psoriasis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/12/18 | Phase 1 | Withdrawn | |||
2014/12/10 | Phase 3 | Completed | |||
2014/05/06 | Phase 2 | Completed | |||
2013/11/19 | Not Applicable | UNKNOWN | |||
2013/09/19 | Phase 1 | Completed | |||
2013/07/09 | Phase 4 | Completed | |||
2012/10/03 | Phase 3 | Completed | |||
2012/03/19 | Phase 2 | Completed | |||
2011/10/18 | Phase 3 | Completed | |||
2011/08/02 | Phase 2 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-5488 | TOPICAL | 0.5 mg in 1 g | 5/31/2021 | |
| IPG PHARMACEUTICALS, INC. | 71085-007 | TOPICAL | 0.5 mg in 1 g | 2/13/2017 | |
| The J. Molner Company LLC | 83148-064 | TOPICAL | 0.5 mg in 1 g | 6/10/2025 | |
| A-S Medication Solutions | 50090-0548 | TOPICAL | 0.5 mg in 1 g | 5/3/2018 | |
| Direct RX | 61919-329 | Topical | .05 mg in 1 g | 6/23/2015 | |
| Aleor Dermaceuticals Limited | 71589-006 | TOPICAL | 0.5 mg in 1 g | 11/30/2021 | |
| Bryant Ranch Prepack | 63629-2392 | TOPICAL | 0.5 mg in 1 g | 4/7/2022 | |
| Bryant Ranch Prepack | 72162-1961 | TOPICAL | 0.5 mg in 1 g | 1/31/2024 | |
| A-S Medication Solutions | 50090-2405 | TOPICAL | 0.5 mg in 1 g | 5/3/2018 | |
| Rebel Distributors Corp | 42254-174 | TOPICAL | 0.5 mg in 1 g | 3/19/2010 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| THEOMOSONE CREAM | N/A | N/A | N/A | 2/19/1999 | |
| KETOCOMP CREAM | N/A | N/A | N/A | 3/21/2003 | |
| THERAPEUTIC-B CREAM | N/A | N/A | N/A | 9/18/1998 | |
| MARSOCINE CREAM | N/A | N/A | N/A | 7/14/2011 | |
| XINAZONE CR | N/A | N/A | N/A | 7/28/2001 | |
| KETASOMYCIN CREAM | N/A | N/A | N/A | 3/21/2003 | |
| DERMOCOMB CREAM | N/A | N/A | N/A | 5/10/2001 | |
| MEGACIN CREAM | N/A | N/A | N/A | 3/21/2003 | |
| DERMAFULIN CREAM | N/A | N/A | N/A | 1/12/2009 | |
| ZINEROL CREAM | N/A | N/A | N/A | 3/21/2003 |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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