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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.
- Source :
-
Journal of drugs in dermatology : JDD [J Drugs Dermatol] 2013 Aug; Vol. 12 (8), pp. 882-7. - Publication Year :
- 2013
-
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.<br />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.<br />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).<br />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Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later.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.<br />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:
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1545-9616
- Volume :
- 12
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of drugs in dermatology : JDD
- Publication Type :
- Academic Journal
- Accession number :
- 23986161