Calcipotriol
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
- Calcipotriol
- Pharmacist Assessment Report
- Calcipotriol: From Plaque Psoriasis (Original Indication Not Recorded in ARTG Data) to Seborrheic Keratosis
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Calcipotriol: From Plaque Psoriasis (Original Indication Not Recorded in ARTG Data) to Seborrheic Keratosis
One-Sentence Summary
Calcipotriol is a topical vitamin D3 analogue, marketed in Australia in a combination foam with betamethasone (Enstilar). The TxGNN model predicts it may be effective for seborrheic keratosis, supported by no registered clinical trials and 4 publications, which are mostly small case series and case reports.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the data compiled for this report (the ARTG entry has no indication text) |
| Predicted New Indication | Seborrheic keratosis |
| TxGNN Prediction Score | 0.9996 |
| 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 are not available in the data compiled for this report. Based on known pharmacology, calcipotriol is a vitamin D3 analogue that binds the vitamin D receptor in keratinocytes. It inhibits proliferation, promotes differentiation and can induce apoptosis.
Seborrheic keratosis is a common benign, hyperproliferative epidermal lesion. Calcipotriol’s established use in hyperproliferative keratotic skin disease makes an effect on these lesions mechanistically plausible. The original indication is not recorded in the ARTG data, so a direct comparison with the original indication cannot be made here.
Other predictions in the list, such as vulvar inverted follicular keratosis, probably follow from similarity to seborrheic keratosis. Predictions for conditions such as vulvovaginitis, bone Paget disease and breast fibrocystic disease have no clear mechanistic support and no evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36752725 | 2023 | Case series (12 patients) | Australas J Dermatol | 0.005% calcipotriol ointment for solitary facial seborrheic keratosis over 3-8 months gave complete regression, with remission lasting 6-10 years |
| 16043912 | 2005 | Clinical/mechanistic study | J Dermatol | Topical active vitamin D3 (tacalcitol, calcipotriol or maxacalcitol) in 116 cases of senile wart (seborrheic keratosis); 35 (30.2%) showed a response, with apoptosis proposed as the mechanism |
| 15577148 | 2004 | Clinical report/Review | Clin Calcium | Overview of treating senile warts with topical active vitamin D3 ointments |
| 10721662 | 2000 | Case report | J Dermatol | Marked response of keratosis lichenoides chronica (a related but distinct keratotic disorder) to calcipotriol ointment |
Study designs were inferred from titles and abstracts only.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 11091R | Enstilar | Foam containing calcipotriol 50 micrograms with betamethasone 500 micrograms (as dipropionate) per g, 60 g | Not available in the data compiled |
Safety Considerations
No product-label warnings or contraindications are available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for safety information.
Contraindication signals from the knowledge graph (not label text): these relate to calcium and vitamin D handling and skin or vascular fragility. They include:
- Hypercalcaemia and other calcium metabolism disorders, nephrocalcinosis, calciphylaxis, hypervitaminosis
- Adrenocortical insufficiency and Addison disease
- Skin atrophy, telangiectasia and peripheral vascular disease
- Several ichthyoses, Darier disease and guttate psoriasis
Drug interactions: 84 potential interactions were identified, but severity levels are unclassified. Examples include corticosteroids (prednisone, prednisolone, hydrocortisone, triamcinolone), acetylsalicylic acid, metformin, simvastatin and clarithromycin. Clinical significance should be verified against the PI.
Site-specific caution: for genital or mucosal predictions (vulvitis, vulvovaginitis, atrophic vaginitis), local irritation and increased absorption are concerns.
Conclusion and Next Steps
Decision: Hold
Rationale:
- Evidence for seborrheic keratosis is limited to small case series and clinical reports, with no registered trials. The remaining predictions rest on model scores alone.
- Safety screening cannot proceed because the product label warnings are missing.
To proceed, the following is needed:
- Retrieve the TGA Product Information to confirm approved indications, warnings and contraindications
- Obtain mechanism of action data (for example from DrugBank)
- Identify a controlled study (ideally a randomised trial) of topical calcipotriol alone versus standard care (for example cryotherapy) in seborrheic keratosis
- Determine whether a calcipotriol-only formulation is appropriate, since the registered Australian product is combined with betamethasone
- Review the interaction list for clinical relevance
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.