Hydrocortisone
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Hydrocortisone: From Corticosteroid Replacement Therapy to Alopecia Areata
One-Sentence Summary
Hydrocortisone is a physiological glucocorticoid classically used as systemic replacement therapy for adrenal insufficiency and as an anti-inflammatory/immunosuppressive agent in topical and systemic forms. The TxGNN model predicts it may be effective for Alopecia Areata, with 1 directly-relevant completed Phase 3 RCT (plus 3 supporting trials in related dermatologic/endocrine contexts) and 20 publications currently supporting this direction, including a head-to-head randomized trial against clobetasol propionate in children.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in evidence pack (TFDA label data pending — see Data Gap DG001) |
| Predicted New Indication | Alopecia Areata |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L2 (1 completed Phase 3 RCT directly using hydrocortisone) |
| Canada Market Status | Not Marketed (未上市) |
| Number of DINs | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available (Data Gap DG002). Based on known pharmacology, hydrocortisone is a naturally-occurring glucocorticoid used therapeutically as a physiological corticosteroid replacement and as an anti-inflammatory/immunosuppressive agent in both systemic and topical formulations. Its efficacy in these established uses is well documented, and mechanistically this same anti-inflammatory/immunosuppressive action may be applicable to alopecia areata.
Alopecia areata is now understood to be a T-cell–mediated autoimmune disease that targets the hair follicle, producing a peri-follicular inflammatory infiltrate (“swarm of bees” pattern histologically). As a corticosteroid, hydrocortisone can suppress this T-cell–driven inflammation and exert local immunosuppression around the follicle, thereby permitting hair regrowth. Topical corticosteroids — as a class — are already established as a first-line treatment option in alopecia areata management guidelines, which gives this prediction a more direct mechanistic grounding than many purely network-inferred TxGNN candidates.
This link is further reinforced by a long historical record of clinical use: intradermal and intracutaneous hydrocortisone injections for alopecia areata were reported as early as the 1950s–1960s, and a modern randomized trial has directly tested hydrocortisone (1% cream) against a higher-potency steroid (clobetasol propionate 0.05%) in pediatric patients, indicating sustained clinical interest in hydrocortisone specifically — not just corticosteroids as a class — for this indication.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomized controlled trial in children with alopecia areata directly comparing hydrocortisone 1% cream vs. clobetasol propionate 0.05% cream — the primary head-to-head evidence for hydrocortisone in this indication |
| NCT00484679 | Phase 2 | Completed | 18 | Evaluated adrenal-axis (HPA) effects of intralesional triamcinolone acetonide in alopecia areata patients; same corticosteroid class but not hydrocortisone itself — class-level supporting evidence only |
| NCT06551818 | NA | Not Yet Recruiting | 72 | Four-arm dose-response study of hair growth products vs. placebo in androgenic (not areata) alopecia; not yet started, low direct relevance |
| NCT04343560 | N/A | Completed | 380 | Studied effects of abnormal steroid metabolome on bone density/strength in mild autonomous cortisol secretion (MACS); not focused on treating alopecia areata — indirect relevance only |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Published results of the RCT comparing hydrocortisone 1% vs. clobetasol propionate 0.05% for alopecia areata in children (corresponds to NCT01453686) |
| 38501938 | 2024 | Cohort | Clinical and Experimental Dermatology | Retrospective single-center analysis of topical corticosteroid occlusion therapy for severe alopecia areata in children |
| 28516731 | 2017 | Review | J Eur Acad Dermatol Venereol | Reviews evidence on HPA-axis activity and cortisol production in alopecia areata patients |
| 13368875 | 1956 | Case series | Medical Times | Historical series treating alopecia areata, partialis, and totalis with cortisone, hydrocortisone, prednisone, and prednisolone |
| 13610145 | 1958 | Case report | Der Hautarzt | Hair regrowth in alopecia areata/maligna following intracutaneous hydrocortisone injection |
| 5989830 | 1966 | Case series | Vestnik Dermatologii i Venerologii | Treatment of alopecia areata and total alopecia via intracutaneous hydrocortisone injections |
| 14158891 | 1963 | Case report | Actas Dermo-Sifiliográficas | Treatment of alopecia areata with intradermal hydrocortisone injections |
| 15692503 | 2005 | Case series | J Am Acad Dermatol | Four cases of congenital alopecia areata, treated with topical agents including corticosteroids |
| 5696522 | 1968 | Observational | British Journal of Dermatology | Scalp blood vessel changes in alopecia areata before and after corticosteroid therapy |
| 22381765 | 2012 | Mechanistic | J Southern Medical University | Serum cortisol levels and PBMC glucocorticoid receptor mRNA expression in severe alopecia areata |
Canada Market Information
Hydrocortisone currently has no approved product license on file for this market (0 DINs; market status: Not Marketed). No dosage form or approved-indication data is available to summarize.
Safety Considerations
Please refer to the package insert for safety information. No key warnings, contraindications, or drug-drug interaction data are currently available in this evidence pack (TFDA label data is a Blocking data gap — DG001 — required before any Stage S1 safety review can proceed).
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A single completed Phase 3 RCT (NCT01453686 / PMID 24226568) directly compares hydrocortisone against an active corticosteroid comparator in pediatric alopecia areata, and this is reinforced by decades of case-level literature on intradermal and topical hydrocortisone use in the same indication. However, the trial had no placebo arm, evidence is limited to a single controlled trial (L2, not L1), and hydrocortisone is not currently marketed in this jurisdiction — so guardrails are warranted before advancing further.
To proceed, the following is needed:
- TFDA package insert warnings/contraindications (Data Gap DG001, Blocking — required before S1 safety review)
- Detailed mechanism of action documentation (Data Gap DG002)
- Confirmation of which route/formulation (topical vs. systemic) is intended for the alopecia areata indication, and its compatibility with available product forms
- Additional placebo-controlled or larger-scale RCTs to strengthen the evidence base beyond the single existing Phase 3 trial
- A market-entry/licensing assessment, since hydrocortisone currently holds no approved license in this jurisdiction (0 DINs)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.