Hydrocortisone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Hydrocortisone: From Autoimmune and Inflammatory Conditions to Alopecia Areata
One-Sentence Summary
Hydrocortisone is a glucocorticoid originally used for autoimmune disease, adrenocortical insufficiency, Crohn disease and other inflammatory conditions. The TxGNN model predicts it may be effective for Alopecia Areata, with 1 clinical trial and 20 publications linked to this direction. However, the only Phase 3 trial used hydrocortisone 1% as the low-potency comparator, so it does not demonstrate that hydrocortisone works.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Autoimmune disease, adrenocortical insufficiency, Crohn disease and other inflammatory conditions, among others (the Singapore licence records contain no approved-indication text) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L1 by the data compiled for this report. Because the only Phase 3 trial used hydrocortisone as a comparator, the real strength is closer to L2–L3 (see below). |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 16 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, hydrocortisone is a glucocorticoid with anti-inflammatory and immunosuppressive effects. Its efficacy in autoimmune and inflammatory disease is established, and mechanistically it may be applicable to alopecia areata.
Alopecia areata is a T-cell-mediated autoimmune disease in which the immune system attacks hair follicles. Suppressing that immune attack is a plausible way to restore hair growth, and the original indications already include autoimmune disease, which supports biological plausibility.
There are important caveats:
- In the only Phase 3 randomised trial, hydrocortisone 1% cream was the low-potency control against clobetasol propionate 0.05%. The trial speaks to the relative inferiority or limited efficacy of hydrocortisone, not to its benefit.
- Reports from the 1950s–1970s describe hair regrowth after intralesional hydrocortisone injection, but these are uncontrolled observations.
- Higher-potency corticosteroids are the established topical and intralesional options, so hydrocortisone is unlikely to be the preferred agent.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomised trial in children with alopecia areata comparing clobetasol propionate 0.05% cream with hydrocortisone 1% cream (2002–2003). Hydrocortisone served as the low-potency comparator; the sample is small. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Randomised trial of clobetasol propionate 0.05% vs hydrocortisone 1% for alopecia areata in children |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata treated with minoxidil and a range of topical agents |
| 13368875 | 1956 | Case series | Medical Times | Clinical observations of cortisone, hydrocortisone and their analogues in alopecia areata |
| 13610145 | 1958 | Case report | Der Hautarzt | Hair regrowth in alopecia areata after intracutaneous hydrocortisone injection |
| 5989830 | 1966 | Clinical observation | Vestnik Dermatologii i Venerologii | Treatment of alopecia areata and total alopecia with intracutaneous hydrocortisone injections |
| 4755919 | 1973 | Clinical observation | Przegląd Dermatologiczny | Intralesional hydrocortisone acetate suspension for severe alopecia areata |
| 13525930 | 1958 | Review | J Med Soc New Jersey | Overview of alopecia areata and other common scalp problems |
| 24326563 | 2013 | Preclinical | J Invest Dermatol Symp Proc | Parathyroid hormone-based therapy in a mouse model of alopecia areata (unrelated agent) |
Singapore Market Information
The 16 valid single-ingredient licences cover topical creams and ointments, one oral tablet and one otic suspension. The records contain no approved-indication text. The main authorisations are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN07203P | Hydrocortison Tablet 10 mg | Tablet | Not stated in the records |
| SIN05104P | Hydrocortisone Cream 1% w/w | Cream | Not stated in the records |
| SIN12211P | H-Cort Cream 1% w/w | Cream | Not stated in the records |
| SIN12212P | H-Cort Ointment 1% w/w | Ointment | Not stated in the records |
| SIN11287P | Ciprobay HC Otic Suspension | Solution | Not stated in the records |
Safety Considerations
Contraindications (from disease associations in the TxGNN knowledge graph, not label text): hypertension, epilepsy, gastric ulcer, kidney disease, liver disease, gallbladder disease, hyperglycaemia, viral skin infections (common wart, anogenital human papillomavirus infection, measles, herpes simplex keratitis) and pituitary-related deficiency disorders.
Drug Interactions: 100 interactions were found. Those listed include:
- Major: adalimumab
- Moderate: zidovudine, isotretinoin, acarbose, acebutolol, acetazolamide, ketorolac, nifedipine, ibuprofen, ethinylestradiol, albiglutide, aldesleukin, alemtuzumab, and some vaccines (tetanus toxoid, adenovirus type 4)
- Minor: formoterol, salbutamol
Package insert warnings and contraindications were not available. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only Phase 3 trial used hydrocortisone as the weak comparator and shows no benefit for it. The remaining support is historical, uncontrolled reports. Higher-potency corticosteroids already serve as the standard option in alopecia areata. The "L1" label overstates the evidence for hydrocortisone itself.
To proceed, the following is needed:
- Full results of NCT01453686 and the JAMA Dermatology trial (24226568), to see how hydrocortisone performed against clobetasol
- Controlled studies of hydrocortisone as the test agent, if there is a reason to prefer it over higher-potency steroids
- Package insert warnings and contraindications from the HSA
- Mechanism of action data
- Approved-indication text for the Singapore licences
- A route and potency assessment (topical vs intralesional) for the Singapore products
Other predicted indications: The other nine predictions (alopecia mucinosa, telogen effluvium, folliculitis decalvans, alopecia antibody deficiency, rare genetic hair disorders, alopecia universalis with onychodystrophy and vitiligo, and steroid-sensitive nephrotic syndrome) have no trials and only indirect or off-target literature. All are rated Hold.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.