Hydrocortisone
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Hydrocortisone: From Corticosteroid Anti-Inflammatory Therapy to Alopecia Areata
One-Sentence Summary
Hydrocortisone is a glucocorticoid corticosteroid; its original approved indications are not documented in the available data (TFDA license records for this ingredient are absent). The TxGNN model predicts it may be effective for Alopecia Areata, with 4 clinical trials and 20 publications currently supporting this direction, including a completed Phase 3 RCT that directly compared hydrocortisone to another topical corticosteroid in this indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not documented in evidence pack (no TFDA license/approved-indication text on file for this ingredient) |
| Predicted New Indication | Alopecia Areata |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L1 |
| US Market Status | Not Marketed |
| Number of NDAs | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the evidence pack (flagged as a High-severity data gap). Based on known drug class information, hydrocortisone is a glucocorticoid corticosteroid that acts by suppressing local immune and inflammatory activity.
Alopecia areata is an autoimmune, non-scarring hair loss disorder in which T-cell–mediated attack on hair follicles drives disease activity. Topical and intralesional corticosteroids are already an established, current standard-of-care treatment for this condition, which gives the TxGNN prediction a clear and clinically validated mechanistic basis: the drug’s known anti-inflammatory/immunosuppressive action directly addresses the T-cell-driven follicular attack that characterizes alopecia areata, rather than relying on an indirect or speculative pathway.
This is further reinforced by a completed Phase 3 RCT (NCT01453686 / PMID 24226568) that directly compared hydrocortisone 1% cream against clobetasol propionate 0.05% cream for alopecia areata in children — i.e., hydrocortisone was already used as an active comparator arm in a head-to-head efficacy trial for this exact indication.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | RCT comparing clobetasol propionate 0.05% cream vs. hydrocortisone 1% cream in children with alopecia areata; direct head-to-head evidence for hydrocortisone in this indication (relevance grade A). |
| NCT00484679 | Phase 2 | Completed | 18 | Evaluated adrenal function after intralesional triamcinolone (not hydrocortisone) in alopecia areata patients; same-indication but different drug — indirect supporting evidence (grade C). |
| NCT06551818 | N/A | Not yet recruiting | 72 | Four-arm dose-response study of hair growth product formulations vs. placebo in androgenic alopecia; design may include corticosteroid-class comparators but not yet recruited, no results available (grade B). |
| NCT04343560 | N/A | Completed | 380 | Studied abnormal steroid metabolism and bone density/quality in patients with mild autonomous cortisol secretion; not a treatment trial and only weakly related to hydrocortisone use in alopecia areata (grade C). |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24226568 | 2014 | RCT | JAMA Dermatology | Randomized clinical trial: clobetasol propionate 0.05% vs. hydrocortisone 1% for alopecia areata in children (publication of NCT01453686). |
| 38501938 | 2024 | Cohort | Clinical and Experimental Dermatology | Retrospective analysis of topical corticosteroid under occlusion for severe alopecia areata (including alopecia totalis/universalis) in children. |
| 36718837 | 2023 | Review | Journal of Cosmetic Dermatology | Systematic review/meta-analysis on laser-based and adjunct therapies for alopecia areata, contextualizing corticosteroid treatment options. |
| 13368875 | 1956 | Case series | Medical Times | Early case series on treatment of alopecia areata, partialis, and totalis with cortisone, hydrocortisone, prednisone, and prednisolone. |
| 13610145 | 1958 | Case report | Der Hautarzt | Reports hair regrowth in alopecia areata and alopecia maligna following intracutaneous hydrocortisone injection. |
| 5989830 | 1966 | Case series | Vestnik Dermatologii i Venerologii | Treatment of alopecia areata and total alopecia with intracutaneous hydrocortisone injections. |
| 14158891 | 1963 | Case report | Actas Dermo-Sifiliográficas | Treatment of alopecia areata with intradermal hydrocortisone injections. |
| 5696522 | 1968 | Case report | British Journal of Dermatology | Examined scalp blood vessel changes in alopecia areata patients before and after corticosteroid therapy. |
| 15692503 | 2005 | Case series | Journal of the American Academy of Dermatology | Describes 4 cases of congenital alopecia areata with long-term follow-up and topical treatment history. |
| 28516731 | 2017 | Review | Journal of the European Academy of Dermatology and Venereology | Reviews evidence on HPA-axis activity and cortisol production in alopecia areata patients. |
US Market Information
No NDA, marketing authorization, or license records for this ingredient are on file in the evidence pack (0 licenses; market status: Not Marketed).
Safety Considerations
Please refer to the package insert for safety information. (No warnings, contraindications, or drug interaction data are currently on file — TFDA label data is flagged as a Blocking data gap, DG001.)
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: A completed Phase 3 RCT directly compared hydrocortisone to another topical corticosteroid in alopecia areata, and the mechanistic rationale (glucocorticoid suppression of T-cell-mediated follicular attack) is well established and already reflected in current clinical practice for this autoimmune condition. However, the existing RCT evidence is limited to a pediatric population, and critical safety and regulatory data for this candidate are still missing.
To proceed, the following is needed:
- TFDA package insert data (warnings/contraindications) — currently a Blocking gap (DG001)
- Detailed mechanism of action documentation from DrugBank — currently a High-severity gap (DG002)
- Confirmation of market/license status for a hydrocortisone product suitable for dermatologic (topical/intralesional) use
- Additional RCT data in adult alopecia areata populations, since current direct trial evidence is pediatric-only
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.