Overview
A topical anti-inflammatory glucocorticoid used in dermatoses, skin allergies, psoriasis, etc.
Indication
For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Associated Conditions
- Allergic Contact Dermatitis
- Atopic Dermatitis
- Psoriasis
- Psoriasis Vulgaris (Plaque Psoriasis)
- Corticosteroid-responsive dermatoses
Research Report
Comprehensive Monograph: Desoximetasone (DB00547)
Executive Summary
Desoximetasone is a synthetic, high-potency, fluorinated topical corticosteroid engineered for its pronounced anti-inflammatory, anti-pruritic, and vasoconstrictive properties.[1] Classified pharmacologically as a Corticosteroid Hormone Receptor Agonist, its primary clinical application is in the management of corticosteroid-responsive dermatoses, including moderate-to-severe plaque psoriasis, atopic dermatitis, and eczema.[1] It is available in various formulations such as cream, ointment, gel, and spray, typically in strengths of 0.05% and 0.25%, allowing for therapeutic flexibility based on lesion type and location.[4]
The therapeutic efficacy of Desoximetasone is well-established, with clinical studies demonstrating its superiority over other corticosteroids like betamethasone valerate for certain indications.[6] However, its high potency necessitates a cautious approach to its use, as the therapeutic benefits are intrinsically linked to a significant risk profile. The principal safety concern is the potential for systemic absorption, particularly with use over large surface areas, on compromised skin barriers, for prolonged durations, or under occlusive dressings. Such absorption can lead to clinically significant systemic adverse effects, most notably reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and ocular complications such as glaucoma and cataracts.[7] Consequently, clinical guidelines strictly limit the duration of therapy, typically to four weeks or less, and emphasize careful patient selection and monitoring, especially in pediatric populations who are more susceptible to systemic toxicity.[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/02/10 | Phase 4 | Completed | |||
2016/12/07 | Phase 4 | Completed | Psoriasis Treatment Center of Central New Jersey | ||
2016/12/06 | Phase 4 | Completed | Psoriasis Treatment Center of Central New Jersey | ||
2016/10/13 | Phase 3 | Completed | |||
2016/04/25 | Phase 3 | UNKNOWN | |||
2015/12/01 | Phase 3 | Completed | |||
2015/11/10 | Phase 2 | Completed | |||
2015/11/03 | Phase 3 | Completed | |||
2015/11/03 | Phase 2 | Completed | |||
2015/01/16 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-2829 | TOPICAL | 0.5 mg in 1 g | 1/12/2011 | |
| Sincerus Florida, LLC | 72934-5069 | TOPICAL | 0.05 g in 100 g | 5/22/2019 | |
| Zydus Lifesciences Limited | 70771-1437 | TOPICAL | 2.5 mg in 1 g | 11/5/2022 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-496 | TOPICAL | 2.5 mg in 1 g | 7/8/2019 | |
| Sincerus Florida, LLC | 72934-6067 | TOPICAL | 0.05 g in 100 g | 5/20/2019 | |
| Padagis Israel Pharmaceuticals Ltd | 45802-495 | TOPICAL | 2.5 mg in 1 g | 1/11/2017 | |
| Actavis Pharma, Inc. | 0472-0479 | TOPICAL | 2.5 mg in 1 g | 1/31/2020 | |
| GROUPE PARIMA INC | 65179-501 | TOPICAL | 0.5 mg in 1 g | 8/25/2016 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-531 | TOPICAL | 2.5 mg in 1 g | 12/11/2018 | |
| Proficient Rx LP | 71205-271 | TOPICAL | 2.5 mg in 1 g | 4/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TOPICORT | bausch health, canada inc. | 02221896 | Cream - Topical | 0.25 % | 3/24/1997 |
| TOPICORT GEL 0.05% | hoechst roussel canada inc. | 01995065 | Gel - Topical | .5 MG / G | 12/31/1995 |
| TOPICORT GEL 0.05% | hoechst canada inc. | 00752541 | Gel - Topical | .05 % | 12/31/1988 |
| TOPICORT MILD CREAM 0.5MG/GM | hoechst roussel canada inc. | 01987526 | Cream - Topical | .5 MG / G | 12/31/1994 |
| TOPICORT 0.25% | hoechst canada inc. | 00420271 | Cream - Topical | .25 % | 12/31/1977 |
| TOPICORT OINTMENT 2.5MG/GM | hoechst roussel canada inc. | 01990942 | Ointment - Topical | 2.5 MG / G | 12/31/1993 |
| TOPICORT MILD .05% | hoechst canada inc. | 00486450 | Cream - Topical | .05 % | 12/31/1980 |
| DESOXI CREAM 0.25% | taropharma, a division of taro pharmaceuticals inc. | 02239069 | Cream - Topical | 0.25 % | 12/22/1999 |
| TOPICORT CRM 2.5MG/GM | hoechst roussel canada inc. | 01987844 | Cream - Topical | 2.5 MG / G | 12/31/1994 |
| TOPICORT | bausch health, canada inc. | 02221926 | Gel - Topical | 0.05 % | 12/4/1996 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
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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