Calcipotriene

Mechanism-of-action class: Enzyme Interactions.

• Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.ICD-10: L40.9

• Calcipotriene is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.contraindicated

Apply a thin layer of calcipotriene ointment USP, 0.005% once or twice daily and rub in gently and completely.

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene.

Clinical Trials Experience In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10 to 15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing. Postmarketing Experience The following adverse reactions have been identified during post approval use of Dovonex Ointment. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Renal and urinary disorders: hypercalciuria Skin and subcutaneous tissue disorders: application site edema, application site pain, contact dermatitis (including allergic contact dermatitis), depigmentation, hypopigmentation, photosensitivity, rash (including erythematous, maculo-papular, and pustular), and urticaria.

Pregnancy Teratogenic Effects Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40 to 60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage 12 mcg/kg/day (132 mcg/m 2 /day); a dosage of 36 mcg/kg/day (396 mcg/m 2 /day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 mcg/kg/day (318 mcg/m 2 /day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rat (43.2 mcg/m 2 /day) and rabbit (17.6 mcg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m 2 /day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, calcipotriene ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of calcipotriene ointment USP, 0.005%.

• Dec 29, 1993NDANDA020273Leo Pharma As
• Jul 22, 1996NDANDA020554Leo Pharma As
• Jan 9, 2006NDANDA021852Leo Pharma As
• May 9, 2008NDANDA022185Leo Pharma As
• Mar 24, 2010ANDAANDA090633Glenmark Pharms
• Oct 6, 2010NDANDA022563Mayne Pharma
• Oct 16, 2015NDANDA207589Leo Pharma As
• Jul 20, 2020NDANDA213422Mc2

1. 1Psoriasis1,34820%
2. 2Drug Ineffective1,11017%
3. 3Diarrhoea4266.4%
4. 4Headache3545.3%
5. 5Pruritus3515.3%
6. 6Nausea3505.3%
7. 7Arthralgia3375.1%
8. 8Rash3264.9%
9. 9Pain3224.9%
10. 10Fatigue2754.2%
11. 11Off Label Use2563.9%
12. 12Psoriatic Arthropathy2493.8%
13. 13Product Use In Unapproved Indication2223.4%
14. 14Erythema2013.0%
15. 15Skin Exfoliation1942.9%

The 10 most recently updated of 183 ClinicalTrials.gov registrations naming Calcipotriene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
  Recruiting · Phase 1 · Interventional · 30 enrolled · Melissa Pugliano-Mauro
  NCT03370406updated 2026-06-01
• A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
  Recruiting · Phase 3 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT06851507updated 2026-05-13
• Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia
  Not yet recruiting · Phase 3 · Interventional · 166 enrolled · Dr. Shalini Gupta
  NCT07453472updated 2026-03-06
• Comparison of Topical Calcipotriol and Intralesional Steroids in Alopecia Areata
  Not yet recruiting · Phase 4 · Interventional · 60 enrolled · Hayat Abad Medical Complex, Peshawar
  NCT07453238updated 2026-03-05
• Acupuncture With Chinese Herbal Cream Compare With Acupuncture With Calcipotriol in Plaque Psoriasis.
  Recruiting · Phase 2 · Interventional · 28 enrolled · Mae Fah Luang University
  NCT07410793updated 2026-02-13
• Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
  Recruiting · Phase 4 · Interventional · 62 enrolled · Hospital Universitario Dr. Jose E. Gonzalez
  NCT07401992updated 2026-02-11
• A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psoriasis Subjects
  Recruiting · Phase 3 · Interventional · 537 enrolled · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
  NCT07357831updated 2026-01-27
• Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart
  Recruiting · Interventional · 60 enrolled · Mazandaran University of Medical Sciences
  NCT06737406updated 2025-12-19
• 5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
  Recruiting · Phase 2 · Phase 3 · Interventional · 200 enrolled · Boston University
  NCT05381597updated 2025-11-28

Frequently asked questions

How does Calcipotriene work?

Mechanism-of-action class: Enzyme Interactions.

What is Calcipotriene used for?

According to FDA labeling, Calcipotriene carries indications including: Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Calcipotriene?

Calcipotriene is classified as Other antipsoriatics for topical use, Vitamin D Analog, Enzyme Interactions, Increased Vitamin Uptake and Modification.

What are the brand names for Calcipotriene?

Calcipotriene is marketed under brand names including Calcitrene, Dovonex, Enstilar, Pellix, Sorilux, Taclonex, Wynzora.

What are the contraindications for Calcipotriene?

Calcipotriene labeling lists contraindications including: Calcipotriene is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.. Always consult the full prescribing information and a clinician.