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 (a completed Phase 3 randomized trial in which hydrocortisone 1% cream served as the comparator) and several publications, mostly small or historical reports. The evidence level is L2.
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 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data for hydrocortisone is not available in the data compiled for this report. Based on its known drug class, hydrocortisone is a glucocorticoid with anti-inflammatory and immunosuppressive effects.
Alopecia areata is a T-cell-mediated autoimmune disease in which the immune system attacks hair follicles. Local glucocorticoid action could plausibly suppress the immune cell infiltrate around the follicle.
There is an important caveat. Hydrocortisone is a low-potency steroid. In the one randomized trial found, it served as the comparator for a higher-potency steroid (clobetasol), not as the main therapy. The evidence therefore supports a steroid class effect more than hydrocortisone-specific 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 was the low-potency comparator; the sample was small. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Clobetasol 0.05% versus hydrocortisone 1% for alopecia areata in children; the publication of the trial above. |
| 15692503 | 2005 | Case report | J Am Acad Dermatol | Four cases of congenital alopecia areata followed for 3–5 years, treated with minoxidil and various topical agents. |
| 13368875 | 1956 | Historical clinical report | Medical Times | Treatment of alopecia areata with cortisone, hydrocortisone and their analogs. |
| 13610145 | 1958 | Historical clinical report | Der Hautarzt | Hair regrowth in alopecia areata after intracutaneous hydrocortisone injection. |
| 4755919 | 1973 | Clinical report | Przeglad Dermatologiczny | Intralesional hydrocortisone acetate suspension injections for severe alopecia areata. |
| 13525930 | 1958 | Review | J Med Soc New Jersey | Clinical overview of alopecia areata and other common scalp problems. |
India Market Information
At least 20 valid single-ingredient licences are recorded, and the list below may be partial. The licence records contain no approved-indication text.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 113711 | Irap 100mg Injection | Vial of 1 injection | Not stated |
| 52816 | Criticort Injection | Vial of 1 injection | Not stated |
| 174259 | Primacort 200mg Injection | Vial of 5 ml injection | Not stated |
| 103759 | Hisone 5 Tablet | Strip of 10 tablets | Not stated |
| 104991 | HC-Cort 20 Tablet | Strip of 10 tablets | Not stated |
Available forms are injectable (vials) and oral (tablets). No topical product is listed, whereas the supporting trial used a topical cream.
Safety Considerations
- Drug Interactions: 722 interactions are recorded. Notable examples include a major interaction with adalimumab and moderate interactions with zidovudine, isotretinoin, acarbose, ibuprofen, ketorolac, nifedipine, ethinylestradiol and aldesleukin.
- Conditions flagged for caution: Hypertension, epilepsy, gastric ulcer, kidney disease, liver disease, hyperglycemia, and certain viral infections (e.g. herpes simplex keratitis, measles, common warts).
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: One completed Phase 3 randomized trial in children with alopecia areata used hydrocortisone 1% cream, and older case series used intralesional hydrocortisone, giving an evidence level of L2. However, hydrocortisone was only the low-potency comparator, so hydrocortisone-specific efficacy is not established.
To proceed, the following is needed:
- A trial that tests hydrocortisone as the primary therapy, ideally versus placebo
- Comparison against higher-potency steroids and current standard treatments
- Confirmation of a topical or intralesional product route, since the listed local products are injectable or oral
- Package insert warnings and contraindications, and detailed mechanism of action data
- A safety plan covering systemic steroid exposure and the interactions listed above
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.