Hydrocortisone Acetate
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Hydrocortisone Acetate
- Hydrocortisone Acetate: From Autoimmune and Inflammatory Conditions to Alopecia Areata
Hydrocortisone Acetate: From Autoimmune and Inflammatory Conditions to Alopecia Areata
One-Sentence Summary
Hydrocortisone acetate is a corticosteroid originally used for autoimmune and inflammatory conditions such as adrenocortical insufficiency, Crohn disease and congenital adrenal hyperplasia. The TxGNN model predicts it may be effective for alopecia areata, with 1 clinical trial and 2 publications currently supporting this direction. The evidence is limited and indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Autoimmune disease, adrenocortical insufficiency, Crohn disease and inflammatory bowel disease, congenital adrenal hyperplasia (from the knowledge-graph indications; no approved indication text is available for the Singapore licences) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.94% |
| Evidence Level | L1 (as assigned in the data compiled for this report; see note below) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 8 |
| Recommended Decision | Hold |
Note on evidence level: Only one Phase 3 trial exists, and hydrocortisone was the low-potency comparator, not the investigational drug. By the strict rules (at least 2 completed Phase 3 RCTs for L1) the evidence is weaker than L1. The practical strength is closer to L2/L3.
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Hydrocortisone acetate is a corticosteroid. Its efficacy in autoimmune and inflammatory conditions is well established, and mechanistically it may be applicable to alopecia areata.
Alopecia areata is a T-cell-mediated autoimmune disease in which the immune privilege of the hair follicle collapses. Corticosteroids suppress local inflammation and lymphocytic infiltration, which fits the drug's known autoimmune and anti-inflammatory uses.
There is an important caveat. Low-potency hydrocortisone is generally considered weak for this condition, and there is no strong direct efficacy data for hydrocortisone acetate. Higher-potency steroids are usually preferred.
Other high-scoring predictions (telogen effluvium, alopecia mucinosa, folliculitis decalvans and several rare genetic hair disorders) have no clinical trials or literature. Most have little mechanistic rationale, so they are not pursued here.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01453686 | Phase 3 | Completed | 41 | Randomised trial of clobetasol propionate 0.05% cream versus hydrocortisone 1% cream in children with alopecia areata. Hydrocortisone was the low-potency comparator. The trial is small and used hydrocortisone, not hydrocortisone acetate. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 4755919 | 1973 | Case series | Przeglad dermatologiczny | Intralesional injections of hydrocortisone acetate suspension for severe alopecia areata (no abstract available) |
| 153470 | 1979 | Review | MMW, Munchener medizinische Wochenschrift | Review of topical skin therapy. It notes that the anti-inflammatory effect of fluocortin butyl ester is about equal to that of hydrocortisone acetate. Not specific to alopecia areata. |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN08804P | HYDRODERM CREAM 1% | Cream | Not specified |
| SIN11172P | YSP HYDROCORT CREAM 1% W/W | Cream | Not specified |
| SIN04767P | HYDROCORTISONE CREAM 1% w/w | Cream | Not specified |
| SIN03781P | SW HYDROCORTISONE CREAM 1% w/w | Cream | Not specified |
| SIN08726P | UCORT CREAM | Cream | Not specified |
Eight valid single-ingredient licences are registered in total, all topical creams. The remaining three are SIN10834P (Fucidin H Cream), SIN08790P (Hydroderm-C Cream 1%) and SIN06454P (Micon-H Cream).
Safety Considerations
Please refer to the package insert for safety information.
The knowledge graph links the drug to contraindications in the following areas. These come from the graph, not from label text:
- Cardiovascular and metabolic: hypertension, hyperglycaemia
- Organ disease: kidney disease, liver disease, gallbladder disease, gastric ulcer
- Neurological: epilepsy
- Infections: measles, herpes simplex virus keratitis, pyoureter
- Endocrine: hypopituitarism, growth hormone deficiency and related pituitary or hypogonadotropic conditions
No drug interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: Only one small Phase 3 trial is available, and hydrocortisone was only the weak comparator. The literature is dated and indirect. All registered Singapore products are low-strength topical creams, and low-potency hydrocortisone is generally considered weak for alopecia areata. The idea is biologically plausible but not yet supported by evidence of efficacy.
To proceed, the following is needed:
- Package insert warnings and contraindications for the Singapore products (a blocking gap for safety screening)
- Mechanism of action data
- Full results of NCT01453686, to see how hydrocortisone performed against clobetasol
- Comparative data showing hydrocortisone acetate offers a benefit over higher-potency steroids already used for alopecia areata
- Assessment of whether the currently registered cream formulations are suitable for scalp use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.