Evigrade

Calcipotriol

AEMPS

Topical antipsoriatic, synthetic vitamin D3 analogue

ATC code: D05AX02

Brand names: Dovonex, Daivonex, Sorilux

Updated · Methodology

Indications

A

Plaque psoriasis

Second line

Calcipotriol as monotherapy or, more often, in a fixed combination with betamethasone (Daivobet, Enstilar) is a treatment option for mild and moderate plaque psoriasis of trunk and limbs (PASI up to 10, BSA up to 10%). CG153, BAD 2024 and AEDV 2022 position calcipotriol as a steroid-sparing agent once disease is controlled by topical corticosteroids: after 2–4 weeks of steroid the regimen switches to calcipotriol, then to 1–2 applications per week for remission maintenance. 2020 reports efficacy comparable to mid-potency topical steroids for monotherapy of moderate psoriasis.

ICD-10: L40.0 · ICD-11: EA90.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Psoriasis

Not recommended

Calcipotriol is a synthetic vitamin D3 analogue, not a «natural» alternative to steroids. The marketing claim of «steroid-free monotherapy for any psoriasis» misleads in severe forms and non-standard sites. For scalp psoriasis, the fixed calcipotriol+betamethasone combination (Daivobet gel, Enstilar foam) is effective; calcipotriol monotherapy is insufficient ( CG153, BAD 2024). On the face and in flexures, calcipotriol is strongly irritating and is not used. In severe psoriasis (PASI above 10, BSA above 10%) any topical therapy is inadequate – phototherapy, methotrexate, ciclosporin, apremilast or biologics are needed. Use of more than 100 g of cream per week for prolonged periods is linked to hypercalcaemia risk. If calcipotriol was prescribed as standalone monotherapy for scalp, flexural or severe psoriasis, consider seeking a second opinion.

ICD-10: L40 · ICD-11: EA90

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Synthetic analogue of 1,25-dihydroxyvitamin D3. Binds the vitamin D receptor (VDR) in keratinocytes and: 1) suppresses excessive proliferation, 2) normalises differentiation, 3) reduces local T-lymphocyte activation and pro-inflammatory cytokine production. Activity on calcium metabolism is 100 times lower than calcitriol, allowing topical use without significant systemic hypercalcaemia at doses up to 100 g of cream per week. Effect develops gradually: first signs of improvement at 2 weeks, peak at 6–8 weeks.

Safety

Contraindications

  • Hypersensitivity to calcipotriol
  • Calcium metabolism disorders (hypercalcaemia, hypercalciuria)
  • Severe renal or hepatic impairment
  • Application on the face
  • Scalp psoriasis as monotherapy (without steroid) – ineffective
  • Doses above 100 g of cream per week

Serious adverse effects

  • Hypercalcaemia and hypercalciuria with doses above 100 g of cream per week or coverage above 30% body surface
  • Increased UV sensitivity
  • Severe irritant dermatitis on the face or mucosa

Common adverse effects

  • Local irritation, burning and itching in the first weeks of use
  • Erythema and skin dryness
  • Psoriasis flare at plaque margins
  • Contact dermatitis

Pregnancy: can you take Calcipotriol?

AEMPS summary of product characteristics (section 4.6): the safety of calcipotriol in pregnant women has not been established. When given orally to animals, calcipotriol showed reproductive toxicity. Calcipotriol is used during pregnancy only if clearly necessary.

Breastfeeding: can you take Calcipotriol?

Hale L3. Systemic absorption is minimal. Do not apply to the breast or nipple area before feeding to avoid direct skin contact with the infant. Use on other sites is compatible with breastfeeding.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

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Frequently asked

What is Calcipotriol used for?

Calcipotriol is evaluated for the following indications with varying evidence strength: Plaque psoriasis (evidence tier A), Psoriasis (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Calcipotriol?

Common side effects of Calcipotriol (≥ 1 in 100): Local irritation, burning and itching in the first weeks of use, Erythema and skin dryness, Psoriasis flare at plaque margins, Contact dermatitis. See the Safety section for uncommon and serious reactions.

Is Calcipotriol safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): the safety of calcipotriol in pregnant women has not been established. When given orally to animals, calcipotriol showed reproductive toxicity. Calcipotriol is used during pregnancy only if clearly necessary.

Is Calcipotriol compatible with breastfeeding?

Hale L3. Systemic absorption is minimal. Do not apply to the breast or nipple area before feeding to avoid direct skin contact with the infant. Use on other sites is compatible with breastfeeding.

Who should not take Calcipotriol?

Calcipotriol is contraindicated in: Hypersensitivity to calcipotriol; Calcium metabolism disorders (hypercalcaemia, hypercalciuria); Severe renal or hepatic impairment; Application on the face; Scalp psoriasis as monotherapy (without steroid) – ineffective. Full list in the Safety section.

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