Hydrocortisone
| Evidence Level: L2 | Predicted Indications: 9 |
Table of Contents
Hydrocortisone: Alopecia areata
One-Sentence Summary
Hydrocortisone is a glucocorticoid with anti-inflammatory and immunosuppressive effects, and it is marketed in Canada in several systemic and topical products. The TxGNN model predicts it may be useful for alopecia areata, with 1 clinical trial and 19 publications retrieved for this direction. The only trial used hydrocortisone 1% cream as the low-potency comparator against clobetasol, so the evidence is at Level L2 and does not by itself show that hydrocortisone is effective in this condition.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 0.9997 |
| Evidence Level | L2 |
| Canada Market Status | Marketed (marketed DINs: 15 of 16; dormant: 1) |
| Number of DINs | 16 (marketed: 15) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, hydrocortisone is a glucocorticoid with anti-inflammatory and immunosuppressive effects.
Alopecia areata is a T-cell-mediated autoimmune disorder in which the immune system attacks hair follicles, causing patchy hair loss. Suppressing local immune activity is therefore mechanistically plausible. Topical and intralesional corticosteroids are already used in clinical practice for this condition, and several older case series (1950s–1970s) describe intralesional hydrocortisone injections.
An important caveat: the available Phase 3 trial used hydrocortisone 1% only as the low-potency comparator against clobetasol. It mainly supports clobetasol’s superiority and gives limited evidence of hydrocortisone’s own efficacy.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomized trial in children with alopecia areata comparing clobetasol propionate 0.05% cream with hydrocortisone 1% cream. Hydrocortisone served as the active low-potency comparator. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Clobetasol 0.05% vs hydrocortisone 1% for alopecia areata in children (the published report of the trial above). |
| 13368875 | 1956 | Cohort | Medical Times | Treatment of alopecia areata with cortisone, hydrocortisone and analogs. |
| 14158890 | 1963 | Cohort | Actas Dermo-Sifiliográficas | Relative efficacy of local injection of different corticoids in alopecia areata. |
| 5989830 | 1966 | Cohort | Vestnik Dermatologii i Venerologii | Intracutaneous hydrocortisone injections in alopecia areata and total alopecia. |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata treated with topical agents including minoxidil. |
| 13525930 | 1958 | Review | J Med Soc New Jersey | Overview of alopecia areata and other common scalp problems. |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 00030619 | SOLU-CORTEF | Not specified | Not specified |
| 02469421 | SANDOZ HYDROCORTISONE | Not specified | Not specified |
| 00030929 | CORTEF | Not specified | Not specified |
| 02524465 | AURO-HYDROCORTISONE | Not specified | Not specified |
| 01954210 | PRAMOX HC LOTION | Lotion (per product name) | Not specified |
Safety Considerations
Please refer to the package insert for safety information.
Drug interaction screening returned 100 records. Examples include a Major interaction with adalimumab, and Moderate interactions with drugs such as ibuprofen, ketorolac, nifedipine, isotretinoin, acarbose and zidovudine. Minor interactions include salbutamol and formoterol.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A completed Phase 3 randomized trial and its publication directly study alopecia areata, and corticosteroids are an established approach. However, hydrocortisone was only the comparator, so the evidence for its own efficacy is limited (Level L2).
To proceed, the following is needed:
- A trial in which hydrocortisone is the test arm, ideally with a placebo or vehicle control
- Package insert warnings and contraindications for the relevant formulations
- Mechanism of action data
- A review of the drug interaction profile, particularly with adalimumab and other immunomodulators
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.