Desoximetasone
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Desoximetasone: From Topical Corticosteroid Therapy to Alopecia Areata
One-Sentence Summary
Desoximetasone is a mid-to-high potency topical corticosteroid, marketed in the US as an ointment, cream and spray. The TxGNN model predicts it may be effective for alopecia areata, with 0 registered clinical trials and 1 publication (a randomized, double-blind, placebo-controlled trial) supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the supplied license records (topical corticosteroid) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.92% |
| Evidence Level | L2 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, desoximetasone is a mid-to-high potency topical corticosteroid. Its local anti-inflammatory and immunosuppressive effects are established for skin conditions, and mechanistically it may be applicable to alopecia areata.
Alopecia areata is a T-cell-mediated autoimmune attack on the hair follicle, so local glucocorticoid immunosuppression is a plausible way to reduce that attack. Together with the very high TxGNN score, this makes the prediction reasonable. A randomized controlled trial of 0.25% desoximetasone cream in alopecia areata (see below) directly tests this idea.
The other nine predictions in the pack (for example alopecia mucinosa, telogen effluvium, folliculitis decalvans and primary cutaneous B-cell lymphoma) have no trials or literature. Their mechanistic links are weak or speculative, and several are rare genetic disorders. Alopecia areata is the only prediction with supporting evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 11030789 | 2000 | RCT | Archives of Dermatology | Randomized, double-blind, placebo-controlled trial of 0.25% desoximetasone cream in alopecia areata. The abstract was not supplied, so results are not summarized here. |
US Market Information
Five of the 20 authorizations are shown. The supplied records contain no approved-indication text.
| Authorization Number | Product Name | Dosage Form |
|---|---|---|
| NDA018594 | Desoximetasone (Sun Pharmaceutical Industries) | Ointment |
| ANDA208164 | Desoximetasone (Lupin Pharmaceuticals) | Cream |
| NDA204141 | Topicort (Sun Pharmaceutical Industries) | Spray |
| ANDA077770 | Desoximetasone (Padagis Israel Pharmaceuticals) | Ointment |
| ANDA206441 | Desoximetasone (Bryant Ranch Prepack) | Spray |
Safety Considerations
Please refer to the package insert for safety information. No drug interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: Only one RCT (2000) supports alopecia areata, with no registered trials, and its results are not available in the pack. Package insert safety data has not been obtained, which blocks progression to safety screening. The prediction is best treated as a research question for now.
To proceed, the following is needed:
- Package insert warnings and contraindications, obtained from the FDA label
- Full text of PMID 11030789, to confirm the efficacy results and dosing regimen
- Detailed mechanism of action data from DrugBank
- A check of whether the available forms (ointment, cream, spray) suit scalp application
- Current registered or ongoing trials in alopecia areata, including comparison with existing topical corticosteroid treatments
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.