The efficacy and safety of combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) (Cal/BD) gel for the treatment of psoriasis in adolescents is supported by study data published in the Journal of the European Academy of Dermatology and Venereology.
This phase 2 study enrolled 107 patients aged 12 to 17 years with at least mild psoriasis of the body and scalp. Patients were instructed to apply Cal/BD gel to the affected area(s) once daily for ≤8 weeks. Study assessments were conducted at baseline and at weeks 2, 4, 6, and 8. At week 4, patients with clear skin per the physician’s global assessment of disease severity (PGA) discontinued the study. The primary outcome measure was the incidence of adverse drug reactions (ADRs), including treatment-emergent adverse events (AEs). Controlled disease per the PGA was used as the primary efficacy measure. An adrenocorticotropic hormone (ACTH) challenge test was performed at weeks 4 and 8 after Cal/BD treatment; serum cortisol concentration ≤18 μg/dL at 30 minutes post-challenge was considered an ADR.
A total of 8 ADRs were reported in 7 patients (7%). Of the ADRs, 3 were of moderate severity: increased blood parathyroid hormone, erythema, and folliculitis. None of the reported ADRs were severe. Overall, 38 patients (36%) reported ≥1 AE, for a total of 62 treatment-emergent AEs. The most common AEs were headache (n=6; 6%), nasopharyngitis (n=6; 6%), and increased blood parathyroid hormone levels (n=4; 4%). During the study, 1 severe AE was observed but was deemed unrelated to treatment. At week 4, 1 patient was withdrawn due to low plasma cortisol levels after ACTH stimulation. No patients had a serum cortisol concentration ≤18 μg/dL at 60 minutes post-ACTH challenge. By week 8, 58% and 69% of patients had controlled disease of the body and scalp, respectively.
These data indicate that Cal/BD gel was relatively well-tolerated in adolescents with body and scalp psoriasis. No unexpected safety signals were observed. As an open-label study with no control group, investigators noted that the strength of these conclusions may be limited. Overall, however, Cal/BD gel appeared to be a “clinically beneficial treatment, with [high] tolerability, for adolescent patients with body/scalp psoriasis,” investigators wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures
Eichenfield LF, Marcoux D, Kurvits M, Liljedahl M. Safety and efficacy of topical, fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial [published online November 13, 2019]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.16077