Introduction
Wynzora Cream is a novel, fixed-combination topical medication approved by the FDA in July 2020 for the treatment of plaque psoriasis. This dual-action formulation combines calcipotriene, a synthetic vitamin D3 analog, and betamethasone dipropionate, a potent corticosteroid, in an innovative cream vehicle designed for enhanced patient acceptability and efficacy.
Mechanism of Action
Wynzora Cream exerts its therapeutic effects through two complementary mechanisms:
Calcipotriene (0.005%): A vitamin D receptor agonist that modulates keratinocyte proliferation and differentiation, reduces epidermal hyperproliferation, and promotes normal keratinization. It also exhibits anti-inflammatory properties by inhibiting T-lymphocyte activation and cytokine production. Betamethasone Dipropionate (0.064%): A high-potency corticosteroid that binds to intracellular glucocorticoid receptors, resulting in anti-inflammatory, immunosuppressive, antipruritic, and vasoconstrictive effects. It inhibits the release of pro-inflammatory cytokines, reduces epidermal hyperplasia, and decreases lymphocyte infiltration.The combination provides synergistic action targeting both the hyperproliferative and inflammatory components of psoriasis.
Indications
- Treatment of plaque psoriasis in adults 18 years and older
- Management of mild to moderate plaque psoriasis affecting up to 30% of body surface area
Dosage and Administration
Standard Dosing: Apply a thin layer to affected areas once daily Application: Gently rub into the skin until no longer visible Duration: Limit use to 8 weeks consecutively Maximum Weekly Dose: Do not exceed 100 g per week Special Populations:- Geriatric: No dosage adjustment required
- Hepatic/Renal Impairment: Use with caution
- Pediatrics: Safety and effectiveness not established
Pharmacokinetics
Absorption: Minimal systemic absorption. Following once-daily application to 30% of body surface area, calcipotriene systemic concentrations were below quantifiable limits, while betamethasone dipropionate showed minimal absorption. Distribution: Primarily local action with negligible systemic distribution Metabolism: Calcipotriene undergoes rapid hepatic metabolism. Betamethasone dipropionate is hydrolyzed to betamethasone 17-propionate and subsequently to betamethasone. Elimination: Metabolites excreted primarily in bile and feces, with renal elimination of conjugated metabolitesContraindications
- Hypersensitivity to any component of the formulation
- Patients with known disorders of calcium metabolism
- Use on erythrodermic, exfoliative, or pustular psoriasis
- Application to areas of skin atrophy or fragile skin
- Use in patients with viral skin infections (herpes simplex, varicella)
- Fungal or bacterial skin infections without appropriate antimicrobial therapy
Warnings and Precautions
HPA Axis Suppression: May cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with potential for glucocorticoid insufficiency Skin Reactions: May cause local reactions including irritation, pruritus, burning, and skin atrophy Photosensitivity: Increased risk of photosensitivity reactions Ocular Exposure: Avoid contact with eyes due to risk of cataract formation and glaucoma Pregnancy: Category C - Use only if potential benefit justifies potential risk Lactation: Use with caution; do not apply to breast area while nursing Pediatric Use: Not recommended due to higher risk of HPA axis suppression Elderly: Increased susceptibility to skin atrophy and HPA axis suppressionDrug Interactions
No formal drug interaction studies conducted, but theoretical interactions include:- Other topical corticosteroids: Increased risk of systemic effects
- Calcium supplements/vitamin D analogs: Potential for hypercalcemia
- CYP3A4 inhibitors: May increase systemic corticosteroid exposure
- Photosensitizing agents: Increased risk of phototoxic reactions
Adverse Effects
Common (≥1%):- Pruritus (3.2%)
- Application site irritation (2.1%)
- Folliculitis (1.5%)
- Skin atrophy (1.2%)
- Burning sensation (1.0%)
- HPA axis suppression (0.8%)
- Hypercalcemia (0.3%)
- Vision changes (cataracts/glaucoma)
- Allergic contact dermatitis
- Secondary skin infections
Monitoring Parameters
Baseline:- Assessment of psoriasis severity (PASI, BSA)
- Evaluation of skin integrity
- Calcium levels in patients at risk for hypercalcemia
- Clinical response at 4 and 8 weeks
- Signs of skin atrophy, striae, or telangiectasia
- Symptoms of HPA axis suppression (fatigue, weakness, hypotension)
- Serum calcium if symptoms suggest hypercalcemia
- Ophthalmic examination with prolonged use
- Assessment for rebound or recurrence
- Evaluation for HPA axis recovery if suppression suspected
Patient Education
Application Instructions:- Apply once daily to affected areas only
- Use the smallest amount necessary to cover lesions
- Wash hands after application unless treating hands
- Do not use occlusive dressings unless directed
- Avoid sun exposure and use sunscreen
- Do not use on face, groin, or axillae unless directed
- Report any signs of skin irritation or infection
- Notify physician if condition worsens or fails to improve
- Inform all healthcare providers of Wynzora use
- Store at room temperature (20-25°C)
- Keep tube tightly closed
- Do not freeze
- Limit use to 8 weeks unless otherwise directed
- Do not use longer than prescribed
References
1. FDA Approval Package: Wynzora Cream. July 2020 2. Lebwohl MG, et al. Fixed Combination Calcipotriene and Betamethasone Dipropionate Cream for Plaque Psoriasis. J Drugs Dermatol. 2019;18(8):800-806 3. Wynzora Cream Prescribing Information. MC2 Therapeutics, 2022 4. Koo J, et al. Safety and Efficacy of Fixed Combination Calcipotriene/Betamethasone Dipropionate Cream in Psoriasis Vulgaris. J Clin Aesthet Dermatol. 2020;13(5):16-22 5. van de Kerkhof PCM, et al. Calcipotriol/Betamethasone Dipropionate Cream for Plaque Psoriasis: A Review of the Clinical Evidence. Am J Clin Dermatol. 2021;22(3):315-326 6. National Psoriasis Foundation Treatment Guidelines. 2021 Update