Acitretin
| Evidence Level: L3 | Predicted Indications: 4 |
Table of Contents
- Acitretin
- Pharmacist Assessment Report
- Acitretin: From an Unspecified Original Indication to Acne
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Other Predicted Indications (Brief Note)
- Conclusion and Next Steps
- Disclaimer
Acitretin: From an Unspecified Original Indication to Acne
One-Sentence Summary
Acitretin is an oral second-generation retinoid marketed in Australia as Neotigason capsules, but the data compiled for this report do not state its approved indication. The TxGNN model predicts it may be effective for acne, with 1 clinical trial and 18 publications retrieved, most of which concern hidradenitis suppurativa (acne inversa) or retinoids in general rather than common acne vulgaris. Evidence is indirect, so this is best treated as a research question.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available in the data compiled for this report |
| Predicted New Indication | Acne (disease) |
| TxGNN Prediction Score | 0.9994 |
| Evidence Level | L3 |
| 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. Based on known information, acitretin is a second-generation retinoid. Retinoids modulate keratinocyte differentiation and proliferation, and they can reduce sebaceous gland activity and follicular hyperkeratinisation. These processes are relevant to acne.
The available evidence mainly concerns hidradenitis suppurativa (acne inversa) and nodulocystic acne, not common acne vulgaris. Oral isotretinoin remains the established retinoid for acne. Acitretin’s teratogenicity and the long contraception period required after treatment limit its practical use. The prediction is biologically plausible, but it is not directly supported for acne vulgaris.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT07708480 | Phase 4 | Completed | 70 | Randomised comparison of apremilast (30 mg twice daily) and acitretin (25 mg twice daily) for 12 weeks in moderate-to-severe hidradenitis suppurativa. The primary outcome was IHS4 score. Results were not available in the data compiled. This is indirect evidence for acne. |
No ANZCTR trials were identified in the data compiled.
Literature Evidence
Of the 18 publications retrieved for acne, the most relevant are listed below.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25640693 | 2015 | Guideline | J Eur Acad Dermatol Venereol | European guideline for hidradenitis suppurativa/acne inversa |
| 20874789 | 2011 | Clinical report | Br J Dermatol | Long-term acitretin therapy in hidradenitis suppurativa |
| 12080949 | 2002 | Case report | Cutis | Nodulocystic acne and hidradenitis suppurativa treated with acitretin |
| 41692081 | 2026 | Review | Clin Dermatol | Vitamin A and retinoids in dermatology, including oral acitretin |
| 9074840 | 1997 | Review | Drugs | Current and potential dermatological uses of retinoids, including severe acne |
| 8573927 | 1995 | Review | Dermatology | Retinoids and sebaceous gland activity; isotretinoin is highly effective in acne |
| 1617858 | 1992 | Review | Clin Pharmacokinet | Pharmacokinetics and efficacy of retinoids; acitretin is mainly successful in psoriasis |
| 29234829 | 2018 | Review | Hautarzt | Drug therapy of acne inversa |
No randomised trials of acitretin in acne vulgaris were identified.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 2019G | Neotigason | Capsule 10 mg (oral) | Not available in the data compiled |
Safety Considerations
Knowledge-graph contraindication signals (from the TxGNN knowledge graph, not product label text):
- Liver: liver failure, drug-induced liver injury
- Metabolic: hypertriglyceridaemia, pancreatitis, diabetes mellitus, diabetic ketoacidosis, obesity disorders, hypoalphalipoproteinaemia
- Eye and neurological: pseudotumor cerebri, intracranial hypertension, vision disorders, blindness, night blindness (including congenital forms and Oguchi disease)
- Bone: hyperostosis
- Psychiatric: anxiety disorder, neurotic disorder, dysthymic disorder, substance abuse/dependence
Drug interactions (100 recorded; main ones):
- Major: doxycycline, minocycline, tetracycline (risk of raised intracranial pressure with retinoids), vitamin A (additive toxicity)
- Moderate: sulfonylureas (acetohexamide, chlorpropamide, glimepiride, glipizide, glyburide, tolazamide, tolbutamide) and naltrexone
Other considerations from the retrieved evidence:
- Acitretin is a known teratogen and is contraindicated in pregnancy. The post-treatment contraception period is long.
- Bone toxicity is a concern in children.
- Dry eye and mucosal dryness are possible adverse effects.
Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.
Other Predicted Indications (Brief Note)
Lower-ranked predictions have little or no supporting evidence, and none is recommended for progression:
- Pediatric systemic lupus erythematosus, familial acanthosis nigricans, familial cutaneous telangiectasia and oropharyngeal cancer syndrome, complement component 4a deficiency, familial localised heat urticaria: prediction only, with no clinical evidence.
- Fetal erythroblastosis, subacute bacterial endocarditis, prolapse of lacrimal gland: no plausible mechanism. These are likely model artefacts, and use in fetal conditions would be inappropriate given acitretin’s teratogenicity.
Conclusion and Next Steps
Decision: Hold
Rationale: The model score is high, but the evidence is indirect. The single trial and most of the literature concern hidradenitis suppurativa, not acne vulgaris, and oral isotretinoin is already the established retinoid for acne. Acitretin’s teratogenicity and long contraception requirement further limit its role.
To proceed, the following is needed:
- The approved indication from the TGA Product Information and the original indication, which were not available in the data compiled
- Product Information warnings and contraindications to complete safety screening
- Mechanism of action data
- Results of the hidradenitis suppurativa trial (NCT07708480), if acne inversa is to be pursued as a refined indication
- Direct comparative data for acitretin in acne vulgaris or nodulocystic acne against isotretinoin
- A pregnancy prevention and monitoring plan consistent with retinoid risk management
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.