Hydrocortisone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Hydrocortisone: From Topical Anti-Itch/Eczema Use to Alopecia Areata
One-Sentence Summary
Hydrocortisone is a glucocorticoid marketed in the US mainly as topical products (creams, lotions and others), including OTC products labelled for eczema and itch relief. The TxGNN model predicts it may be effective for alopecia areata, with 1 Phase 3 randomized trial (in which hydrocortisone was the comparator, not the test drug) and 21 publications retrieved, most of them old or indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the license records (product names suggest eczema and itch relief) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L2 (see note below) |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 |
| Recommended Decision | Hold |
Evidence level note: the pack labels this L1, but under the stated rules L1 needs at least two completed Phase 3 RCTs. Only one exists here (NCT01453686), and hydrocortisone was its control arm, so it is graded L2 at most.
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the pack. Based on known information, hydrocortisone is a glucocorticoid with anti-inflammatory and immunosuppressive effects. Its efficacy in steroid-responsive skin conditions such as eczema is established, and mechanistically it may be applicable to alopecia areata.
Alopecia areata is a T-cell-mediated autoimmune attack on the hair follicle. Topical and intralesional corticosteroids are an established immunosuppressive approach for it, and this class effect is the basis of the prediction. Historical reports from 1956 to 1966 describe intradermal hydrocortisone injections for alopecia areata, which fits the idea.
The main caveat is potency. The only Phase 3 RCT used hydrocortisone 1% as the low-potency comparator against clobetasol 0.05%. It supports the steroid class effect but does not show that hydrocortisone is a preferred therapy, and the pack does not include the trial outcomes. Any real value would have to be shown against higher-potency steroids or JAK inhibitors.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Clobetasol 0.05% cream vs hydrocortisone 1% cream in children with alopecia areata. Hydrocortisone is the comparator arm; results are not in the pack. |
| NCT00484679 | Phase 2 | Completed | 18 | Intralesional triamcinolone and adrenal function in alopecia areata. Hydrocortisone is probably relevant only to adrenal axis assessment. |
| NCT06551818 | N/A | Not yet recruiting | 72 | Four-arm, placebo-controlled hair growth product study in androgenic alopecia. The role of hydrocortisone is unclear. |
| NCT04343560 | N/A | Completed | 380 | Steroid metabolome and bone quality in mild autonomous cortisol secretion. Not related to alopecia areata treatment. |
Only the first trial is direct evidence, and hydrocortisone was its control rather than the test agent.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatol | Clobetasol 0.05% vs hydrocortisone 1% in children with alopecia areata (publication of NCT01453686). |
| 38501938 | 2024 | Retrospective clinical study | Clin Exp Dermatol | Topical corticosteroid under occlusion for severe alopecia areata in children. Class-level evidence, not hydrocortisone-specific. |
| 36718837 | 2023 | Systematic review/meta-analysis | J Cosmet Dermatol | Fractional laser alone or combined in alopecia areata. Indirect; not about hydrocortisone. |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata treated with minoxidil and a range of topical agents. |
| 28516731 | 2017 | Review | J Eur Acad Dermatol Venereol | Whether the HPA axis is hyperactive in alopecia areata; background on cortisol and stress. |
| 13368875 | 1956 | Historical clinical report | Medical Times | Treatment of alopecia areata, partialis and totalis with cortisone, hydrocortisone, prednisone and prednisolone. |
| 13610145 | 1958 | Historical report | Der Hautarzt | Hair growth in alopecia areata after intracutaneous hydrocortisone injection (title only; no abstract). |
| 14158891 | 1963 | Historical report | Actas Dermosifiliogr | Intradermal hydrocortisone injections for alopecia areata (title only; no abstract). |
| 5989830 | 1966 | Historical report | Vestn Dermatol Venerol | Intracutaneous hydrocortisone injections in alopecia areata and total alopecia (title only; no abstract). |
| 28094416 | 2017 | Veterinary case report | Tierarztl Prax K | German shepherd dog with alopecia areata; topical tacrolimus and hydrocortisone aceponate were ineffective. |
The only modern RCT compares two steroid potencies. The hydrocortisone-specific reports are 1950s–60s papers without abstracts in the pack.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA089074 | hydrocortisone (Bryant Ranch Prepack) | Lotion | Not stated in record |
| part348 | Intensive Healing Eczema (Walgreens) | Lotion | Not stated in record |
| M017 | Hydrocortisone (Safetec of America) | Cream | Not stated in record |
| M017 | WINCO Hydrocortisone (WinCo Foods) | Cream | Not stated in record |
| M017 | Family Care Anti-Itch (United Exchange Corp.) | Cream | Not stated in record |
There are 20 authorizations in total. Other dosage forms on the market are oral tablets, solution, spray and ointment.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only Phase 3 RCT used hydrocortisone 1% as the low-potency control, so it supports the steroid class effect but not hydrocortisone itself, and no outcomes are available. Higher-potency steroids and JAK inhibitors are the more likely comparators. The other nine predicted indications are L4–L5, and none has clinical evidence supporting hydrocortisone.
To proceed, the following is needed:
- Trial outcomes for NCT01453686 and the JAMA Dermatology 2014 paper, to see how hydrocortisone 1% performed against clobetasol
- Package insert warnings and contraindications (a blocking gap for safety screening)
- Detailed mechanism-of-action data from DrugBank
- Approved indication text for the US licenses, to confirm the original indication
- Comparative evidence against higher-potency topical steroids and JAK inhibitors, to show any added value
- Route and formulation assessment (topical vs intralesional) for scalp use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.