1. Effect of calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamic-pituitary-adrenal axis and calcium homeostasis in subjects with extensive psoriasis vulgaris: an open, non-controlled, 8-week trial.
- Author
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Silver S, Tuppal R, Gupta AK, Clonier F, Olesen M, Leeder R, and Taraska V
- Subjects
- Administration, Cutaneous, Adult, Betamethasone administration & dosage, Betamethasone adverse effects, Betamethasone therapeutic use, Calcitriol administration & dosage, Calcitriol adverse effects, Calcitriol therapeutic use, Calcium metabolism, Creatinine urine, Dermatologic Agents administration & dosage, Dermatologic Agents therapeutic use, Drug Combinations, Female, Follow-Up Studies, Gels, Humans, Hypothalamo-Hypophyseal System drug effects, Male, Middle Aged, Pituitary-Adrenal System drug effects, Psoriasis pathology, Severity of Illness Index, Suspensions, Time Factors, Betamethasone analogs & derivatives, Calcitriol analogs & derivatives, Dermatologic Agents adverse effects, Psoriasis drug therapy
- Abstract
Background: The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate is effective and safe in the treatment of psoriasis on the body and scalp within the general psoriasis patient population., Objective: To evaluate the systemic effects of once-daily use of two-compound topical suspension/gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium homeostasis in subjects with extensive psoriasis vulgaris., Methods: An open-label, single-group, 8-week trial in 43 subjects with extensive psoriasis covering 15-30% of the body surface area. Blood and 24-hour urine samples were collected and a standard-dose adrenocorticotropic hormone (ACTH) stimulation test was performed at baseline, weeks 4 and 8. Primary endpoints were serum cortisol 30 minutes after ACTH injection (HPA axis response abnormal at serum cortisol ≤18 μg/dL) and changes from baseline in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urine calcium:creatinine ratio (Ca:Crea)., Results: Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later. None of the subjects who continued treatment to week 8 showed signs of adrenal suppression. There were no clinically relevant mean changes from baseline to weeks 4 and 8 in sCa, 24hCa or Ca:Crea and no subject had sCa above the reference range., Conclusion: The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate may be applied once daily to extensive psoriasis vulgaris without generally causing adrenal suppression or disturbance of calcium homeostasis, consistent with previous findings. In a small number of patients with extensive psoriasis treated with large volumes of topical suspension, adrenal suppression may be observed. In the real-world setting, it is anticipated that systemic side-effects would occur in only a few cases within the general psoriasis patient population. ClinicalTrials.gov Identifier:
- Published
- 2013