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 |
|---|---|---|---|---|---|
2008/04/15 | Phase 3 | Completed | |||
2007/05/07 | Not Applicable | Terminated | |||
2007/02/19 | Phase 4 | Completed | |||
2007/02/19 | N/A | Completed | |||
2007/02/19 | Phase 4 | Completed | |||
2006/11/17 | Phase 3 | Completed | |||
2006/10/27 | Phase 2 | Completed | Center for Vulvovaginal Disorders |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-9460 | TOPICAL | 0.5 mg in 1 g | 10/31/2022 | |
| Novel Laboratories, Inc. | 40032-028 | TOPICAL | 0.5 mg in 1 mL | 4/28/2016 | |
| Galderma Laboratories, L.P. | 0299-3849 | TOPICAL | 0.05 g in 1 mL | 5/9/2023 | |
| Akorn | 50383-266 | TOPICAL | 0.4625 mg in 1 mL | 3/11/2022 | |
| Akorn | 50383-978 | TOPICAL | .05 g in 100 mL | 3/9/2022 | |
| Galderma Laboratories, L.P. | 0299-3847 | TOPICAL | 0.05 g in 100 mL | 2/21/2023 | |
| A-S Medication Solutions | 50090-3820 | TOPICAL | 0.5 mg in 1 g | 8/27/2019 | |
| Physicians Total Care, Inc. | 54868-5421 | TOPICAL | 0.5 mg in 1 g | 5/2/2012 | |
| Encube Ethicals Private Limited | 21922-017 | TOPICAL | 0.5 mg in 1 g | 12/22/2023 | |
| Teligent Pharma, Inc. | 52565-051 | TOPICAL | 0.5 mg in 1 g | 8/27/2019 |
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 |
|---|---|---|---|---|---|
| ZINDIK CREAM | N/A | N/A | N/A | 3/21/2003 | |
| NYCLOMYCIN CREAM | N/A | N/A | N/A | 5/30/2001 | |
| FUKOLIX CREAM | N/A | N/A | N/A | 9/18/1998 | |
| COTACOMB II CREAM | N/A | N/A | N/A | 2/12/2000 | |
| KABANSONE CR | N/A | N/A | N/A | 8/23/1999 | |
| CLOFULIN CREAM | N/A | N/A | N/A | 11/16/2009 | |
| MARCLOMINE CREAM | N/A | N/A | N/A | 1/12/2009 | |
| DERMOKING CREAM | N/A | N/A | N/A | 3/23/2009 | |
| VIDA-CLOBETASOL CREAM 0.05% | N/A | N/A | N/A | 9/18/1995 | |
| EURINE 200 CREAM | N/A | N/A | N/A | 11/16/2009 |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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