Acitretin
| Evidence Level: L3 | Predicted Indications: 4 |
Table of Contents
- Acitretin
- Pharmacist Assessment Report
- Acitretin: From Severe Psoriasis (Retinoid Therapy) to acne (disease)
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Cytotoxicity
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Acitretin: From Severe Psoriasis (Retinoid Therapy) to acne (disease)
One-Sentence Summary
Acitretin is a second-generation oral retinoid that is marketed in India as a single-ingredient capsule or tablet. The TxGNN model predicts it may be effective for acne, but the supporting evidence is mostly indirect: 1 clinical trial (in hidradenitis suppurativa, not acne vulgaris) and 18 publications, mainly reviews, case reports and a guideline.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the India licence data compiled for this report |
| Predicted New Indication | Acne (disease) |
| TxGNN Prediction Score | 0.9994 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, acitretin is a second-generation systemic retinoid. It modulates keratinocyte differentiation and proliferation and has anti-inflammatory effects. Retinoids reduce sebaceous gland activity and follicular hyperkeratinization, which are core acne pathways. This gives a plausible mechanistic link to acne.
The available clinical evidence, however, concerns acne inversa (hidradenitis suppurativa) and a single case of nodulocystic acne. It does not concern conventional acne vulgaris. Isotretinoin, not acitretin, is the established systemic retinoid for acne vulgaris. Acitretin is also strongly teratogenic and has a very long effective washout period, because it can be converted to etretinate in the presence of alcohol. This limits its use in women of childbearing potential.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07708480 | Phase 4 | Completed | 70 | Randomized comparison of apremilast (30 mg twice daily) vs acitretin (25 mg twice daily) for 12 weeks in moderate-to-severe hidradenitis suppurativa. The primary outcome is IHS4 score. Results are not available, and the trial does not address acne vulgaris. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25640693 | 2015 | Guideline | J Eur Acad Dermatol Venereol | European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa |
| 20874789 | 2011 | Clinical study | Br J Dermatol | Long-term results of acitretin in hidradenitis suppurativa. Earlier case reports described promising results. |
| 12080949 | 2002 | Case report | Cutis | Patient with nodulocystic acne and hidradenitis suppurativa treated with acitretin after two courses of isotretinoin |
| 29234829 | 2018 | Review | Hautarzt | Drug therapy of acne inversa (antibiotics, TNF-α inhibitors, adalimumab) |
| 41692081 | 2026 | Review | Clin Dermatol | Vitamin A and retinoids in dermatology, including oral acitretin |
| 9074840 | 1997 | Review | Drugs | Current use of retinoids in psoriasis, keratinization disorders, severe acne and skin cancer chemoprevention |
| 11586072 | 2001 | Review | Skin Pharmacol Appl Skin Physiol | Retinoid mechanisms and likely future dermatological indications |
| 8573927 | 1995 | Review | Dermatology | Retinoids and sebaceous gland activity. Isotretinoin’s anti-acne effect is attributed to inhibition of sebaceous gland activity. |
| 1617858 | 1992 | Review | Clin Pharmacokinet | Pharmacokinetics and efficacy of retinoids. Acitretin and etretinate are most successful in psoriasis, while isotretinoin is used for severe acne. |
| 2112772 | 1990 | Mechanism study | Prostaglandins | Retinoids, including acitretin, inhibit eosinophil LTC4 release, which may contribute to anti-inflammatory effects |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 248742 | Zoratame 10mg Capsule (Cipla Ltd) | Strip of 10 capsules | Not stated |
| 592 | Actoid 25mg Capsule (Intas Pharmaceuticals Ltd) | Strip of 10 capsules | Not stated |
| 7677 | Acitrin 20mg Capsule (Ipca Laboratories Ltd) | Strip of 10 capsules | Not stated |
| 372 | Acrotac 25mg Capsule (Sun Pharmaceutical Industries Ltd) | Strip of 20 capsules | Not stated |
| 5297 | Acetroin 25mg Tablet (Nidus Pharma Pvt Ltd) | Strip of 10 tablets | Not stated |
A total of 20 valid single-ingredient registrations are on record. Only the five above are shown.
Cytotoxicity
Acitretin is not an antineoplastic drug, so this section does not apply.
Safety Considerations
- Disease associations flagged in the knowledge graph (these come from the TxGNN knowledge graph, not from label text): liver failure, drug-induced liver injury, pancreatitis, hypertriglyceridemia, diabetes mellitus and diabetic ketoacidosis, obesity, pseudotumor cerebri and intracranial hypertension, vision disorders including night blindness and blindness, hyperostosis, anxiety and dysthymic disorders, and substance abuse/dependence.
- Teratogenicity: acitretin is a known human teratogen with a very long effective washout period, so it is a major concern for women of childbearing potential.
- Drug interactions: 113 interactions were identified. The major ones are:
- Doxycycline, minocycline and tetracycline
- Vitamin A
- Moderate interactions include sulfonylureas (acetohexamide, chlorpropamide, glimepiride, glipizide, glyburide, tolazamide, tolbutamide) and naltrexone.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanistic link to acne is plausible, but the only direct clinical data concern hidradenitis suppurativa. These are one trial without results, plus case-level reports. There is no evidence in acne vulgaris, where isotretinoin is already the established retinoid. Acitretin’s teratogenicity and organ toxicity add a significant safety burden.
To proceed, the following is needed:
- Package insert warnings and contraindications for the Indian-marketed products, plus the approved indication text, which is blank in the licence records
- Detailed mechanism of action data
- Controlled clinical data in acne vulgaris, or in nodulocystic or retinoid-responsive acne subtypes, and published results of the hidradenitis suppurativa trial
- A pregnancy-prevention and risk-management plan, and a comparison against isotretinoin as the standard retinoid
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.