Hydrocortisone
| Evidence Level: L2 | Predicted Indications: 10 |
Table of Contents
Hydrocortisone: From Topical Corticosteroid Use to Alopecia Areata
One-Sentence Summary
Hydrocortisone is a low-potency glucocorticoid, marketed in South Africa mainly as topical products (creams, ointments, otic drops). The TxGNN model predicts it may be useful for alopecia areata, with 4 clinical trials and 20 publications retrieved. Only one trial tests hydrocortisone directly in this disease, and there it is the low-potency comparator, so the evidence is indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the available registration records |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.97% (all top candidates score about 99.9%, so the score does not discriminate) |
| Evidence Level | L2 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 12 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this record. Based on known information, hydrocortisone is a glucocorticoid, and its anti-inflammatory and immunosuppressive effects are well established in inflammatory skin conditions. Mechanistically, it may be applicable to alopecia areata.
Alopecia areata is an autoimmune condition in which the immune system attacks hair follicles. Topical, intralesional and systemic corticosteroids are an established drug class for it, because they dampen that immune attack. Historical reports from the 1950s and 1960s also describe intradermal hydrocortisone injections for this condition.
The rationale comes from the class effect, not from proof that hydrocortisone itself works. In modern practice, higher-potency steroids are generally used for alopecia areata. In the one Phase 3 trial, hydrocortisone 1% was the weaker comparator.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomised trial of clobetasol 0.05% cream vs hydrocortisone 1% cream in children with alopecia areata. It is the only trial with hydrocortisone in this disease. Hydrocortisone is the low-potency comparator, so it does not show efficacy versus placebo. |
| NCT00484679 | Phase 2 | Completed | 18 | Intralesional triamcinolone (Kenalog-10) in alopecia areata, assessing adrenal function. The test agent is triamcinolone, not hydrocortisone. |
| NCT06551818 | Not applicable | Not yet recruiting | 72 | Four-arm, placebo-controlled dose-response study of hair growth products in mild to moderate androgenic alopecia. The link to hydrocortisone cannot be confirmed. |
| NCT04343560 | Not applicable | Completed | 380 | Observational study of steroid metabolism and bone strength in mild autonomous cortisol secretion. It is not about alopecia treatment. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Publication of the clobetasol 0.05% vs hydrocortisone 1% trial in children with alopecia areata (same study as NCT01453686). |
| 38501938 | 2024 | Retrospective analysis | Clin Exp Dermatol | Topical corticosteroids under occlusion for severe alopecia areata in children. Hydrocortisone is not specifically identified. |
| 13610145 | 1958 | Historical report | Der Hautarzt | Hair regrowth after intradermal hydrocortisone injection in alopecia areata. No abstract available. |
| 14158891 | 1963 | Historical report | Actas Dermo-Sifiliograficas | Intradermal hydrocortisone injections for alopecia areata. No abstract available. |
| 5989830 | 1966 | Historical report | Vestnik Dermatologii i Venerologii | Intracutaneous hydrocortisone injections in alopecia areata and total alopecia. No abstract available. |
| 13368875 | 1956 | Historical clinical report | Medical Times | Treatment of alopecia areata with cortisone, hydrocortisone and their analogues. No abstract available. |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata, treated with minoxidil and topical agents. |
| 36718837 | 2023 | Systematic review / meta-analysis | J Cosmet Dermatol | Fractional laser for alopecia areata. It is not about hydrocortisone. |
| 28516731 | 2017 | Review / commentary | J Eur Acad Dermatol Venereol | Discusses whether hypothalamic-pituitary-adrenal axis hyperactivity occurs in alopecia areata. It is not a treatment study. |
The other 11 retrieved papers are off-target (hormone levels, unrelated syndromes, animal studies, or side-effect case reports) and are not listed.
South Africa Market Information
There are 12 SAHPRA registrations. Five main ones are listed below; forms in the wider set also include a suppository. The available data do not give approved indication text or Essential Medicines List (EML) status.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. H/13.4.1/109 | Locoid | Ointment | Not stated in available data |
| Reg. No. 35/13.4.1/0384 | Vari-hydrocortisone | Cream | Not stated in available data |
| Reg. No. R/13.4.1/202 | Skincalm | Cream | Not stated in available data |
| Reg. No. 33/16.2/0024 | Ciprobay HC Otic Drops | Drops | Not stated in available data |
| Reg. No. 35/13.4.1/0392 | Elozart | Cream | Not stated in available data |
Most registered products are topical creams and ointments. This suits skin conditions, but no product is registered for alopecia areata in the available data.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
No drug-interaction records were found in the query. Two points from the retrieved evidence are relevant:
- One trial (NCT00484679) specifically examined adrenal function during intralesional steroid treatment for alopecia areata.
- Papers in another indication note adrenal insufficiency after prolonged glucocorticoid use and withdrawal.
Neither is a hydrocortisone-specific finding for alopecia areata.
Conclusion and Next Steps
Decision: Hold
Rationale: The class-level rationale for corticosteroids in alopecia areata is sound. However, the only Phase 3 RCT uses hydrocortisone as the weak comparator, not as the test therapy. No placebo-controlled evidence exists for hydrocortisone in this disease, and the safety review cannot start until the package insert data are obtained. The other nine predicted indications have only L4–L5 evidence (case reports, mechanistic studies or prediction alone) and are also on Hold.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Approved indication text for the registered South African products, and confirmation of EML status
- A review of whether hydrocortisone 1% adds value over the higher-potency corticosteroids already used for alopecia areata
- Placebo-controlled or head-to-head efficacy data for hydrocortisone in alopecia areata
These results are for research reference only and do not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.