Hydrocortisone Acetate

Evidence Level: L2

Predicted Indications: 9

Hydrocortisone Acetate

Pharmacist Assessment Report

Hydrocortisone Acetate: Alopecia areata

One-Sentence Summary

Hydrocortisone acetate is a low-potency corticosteroid with anti-inflammatory and immunosuppressive activity. The TxGNN model predicts it may be effective for alopecia areata, with 1 clinical trial and 2 publications in the data compiled for this report. The evidence level is L2, and the trial used hydrocortisone only as a comparator.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Alopecia areata
TxGNN Prediction Score	0.9994
Evidence Level	L2
Australia Market Status	Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items	1 (valid: 1)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Hydrocortisone is a glucocorticoid, and glucocorticoids are generally anti-inflammatory and immunosuppressive.

Alopecia areata is a T-cell-mediated autoimmune disease affecting the hair follicle. Corticosteroids are an established treatment class for it, so the mechanistic link is plausible.

Hydrocortisone is a low-potency corticosteroid. Higher-potency agents (for example clobetasol or intralesional triamcinolone) are generally preferred, which limits the expected efficacy of hydrocortisone itself.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrolment	Key Findings
NCT01453686	Phase 3	Completed	41	Randomised controlled trial in children with alopecia areata comparing clobetasol propionate 0.05% cream with hydrocortisone 1% cream. Hydrocortisone was the low-potency comparator, not the investigational arm. The sample is small, and the formulation was hydrocortisone 1%, not hydrocortisone acetate specifically.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
4755919	1973	Case series / clinical report	Przeglad dermatologiczny	Intralesional subcutaneous injections of hydrocortisone acetate suspension for severe alopecia areata (non-English; no abstract available).
153470	1979	Review	MMW, Munchener medizinische Wochenschrift	Review of topical skin therapy (non-English). It notes that the anti-inflammatory effect of fluocortin butyl ester is about equal to that of hydrocortisone acetate. It is not specific to alopecia areata.

Australia Market Information

ARTG Number	Product Name	Dosage Form	Approved Indication
ARTG 10831C	Cortic-DS 1%	Ointment containing hydrocortisone acetate 10 mg per g, 30 g	Not stated in the data compiled

Safety Considerations

Conditions recorded as contraindicated or to be avoided in related drug data: hypertension, epilepsy, gastric ulcer, kidney disease, liver disease, gallbladder disease, hyperglycaemia, measles, herpes simplex virus keratitis, and pituitary hormone deficiency or hypogonadotropic hypogonadism conditions. These are not drawn from label text.

For full warnings, contraindications and interaction information, please refer to the TGA-approved Product Information (PI).

Conclusion and Next Steps

Decision: Hold

Rationale: The only trial of alopecia areata used hydrocortisone 1% cream as the low-potency comparator, and the one other directly relevant publication is a 1973 case series without an abstract. The small, comparator-only evidence does not show that hydrocortisone acetate is effective. Higher-potency corticosteroids are generally preferred.

To proceed, the following is needed:

Review of the full NCT01453686 results to see how the hydrocortisone arm performed
Comparative data against higher-potency corticosteroids in alopecia areata
Mechanism of action data
Warnings and contraindications from the TGA-approved Product Information

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.