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. The TxGNN model predicts it may be useful for alopecia areata, with 1 clinical trial and a small body of publications (one randomised trial in children, plus mostly historical case reports) pointing in this direction. The evidence level is L2, and in the available trial hydrocortisone was the low-potency comparator rather than the test treatment.
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 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Hydrocortisone is a glucocorticoid, a class with well-known anti-inflammatory and immunosuppressive effects.
Alopecia areata is a T-cell-mediated autoimmune disease in which the immune system attacks hair follicles, so corticosteroid therapy (topical or intralesional) has a plausible mechanism. Corticosteroids are already used in this condition as a class.
An important caveat: hydrocortisone is a low-potency agent. In the one randomised trial available, it served as the comparator against clobetasol propionate, a super-potent steroid, and the published result favoured clobetasol. The evidence therefore mainly supports a class effect rather than hydrocortisone’s own efficacy.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomised trial of clobetasol propionate 0.05% cream versus hydrocortisone 1% cream in children with alopecia areata (2002–2003). Hydrocortisone was the active low-potency comparator; the published result favoured clobetasol. |
No ANZCTR identifiers were found in the data compiled for this report.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Clobetasol 0.05% versus hydrocortisone 1% for alopecia areata in children; clobetasol favoured |
| 13368875 | 1956 | Historical case series | Medical Times | Treatment of alopecia areata with cortisone, hydrocortisone and analogues |
| 13610145 | 1958 | Historical clinical report | Der Hautarzt | Hair regrowth after intracutaneous hydrocortisone injection |
| 4755919 | 1973 | Clinical report | Przeglad Dermatologiczny | Intralesional hydrocortisone acetate suspension for severe alopecia areata |
| 14158891 | 1963 | Clinical report | Actas Dermo-Sifiliograficas | Intradermal hydrocortisone injections for alopecia areata |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata treated with minoxidil and topical agents |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 13863P | Hydrocortisone Viatris 4 | Tablet 4 mg (oral) | Not available in the data compiled for this report |
One valid single-ingredient licence is listed; the product is an oral tablet.
Safety Considerations
- Disease-related cautions (from drug–disease contraindication relations, not label text): hypertension, epilepsy, gastric ulcer, kidney disease, liver disease, hyperglycaemia, and certain viral infections (e.g. herpes simplex keratitis, measles, common wart).
- Drug Interactions: 100 interactions were identified. Notable examples include adalimumab (Major), and Moderate interactions with zidovudine, isotretinoin, ibuprofen, ketorolac, nifedipine, ethinylestradiol, acarbose and acetazolamide.
For full warnings and contraindications, please refer to the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A completed randomised Phase 3 trial in children with alopecia areata used hydrocortisone 1% cream, supported by older reports of intralesional hydrocortisone, giving an evidence level of L2. However, hydrocortisone was the low-potency comparator and the published trial favoured clobetasol, so benefit from hydrocortisone itself is not established.
To proceed, the following is needed:
- Head-to-head or placebo-controlled data on hydrocortisone itself in alopecia areata, ideally in adults as well as children
- Confirmation of a suitable topical or intralesional formulation, as the listed Australian product is an oral tablet
- Mechanism of action data and a safety review based on the TGA Product Information, including monitoring plans for long-term corticosteroid exposure
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.