PMID- 24980277 OWN - NLM STAT- MEDLINE DCOM- 20150818 LR - 20220311 IS - 1365-2133 (Electronic) IS - 0007-0963 (Print) IS - 0007-0963 (Linking) VI - 171 IP - 6 DP - 2014 Dec TI - Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age. PG - 1470-7 LID - 10.1111/bjd.13235 [doi] AB - BACKGROUND: Plaque psoriasis has a relatively high prevalence in adolescence, resulting in a significant impact on quality of life, including social interactions. OBJECTIVES: The primary objective was to assess the safety of once-daily application of fixed-combination calcipotriol plus betamethasone dipropionate gel in adolescent scalp psoriasis. Assessment of efficacy was a secondary objective. METHODS: This phase II, multicentre, single-arm, open-label, 8-week trial included patients aged 12-17 years with moderate-to-very severe scalp psoriasis according to Investigator's Global Assessment (IGA) (>/= 10% of the scalp area affected). RESULTS: Seventy-eight patients received treatment. Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin-corrected serum calcium (0.00 mmol L(-1)), 24-h urinary calcium excretion (-0.03 mmol per 24 h) and urinary calcium-to-creatinine ratio (-0.12 mmol g(-1)) were not considered clinically relevant. At the end of treatment 66 patients (85%) were clear or almost clear according to IGA. There was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 (96%) had no or mild pruritus compared with 14 (18%) at baseline. CONCLUSIONS: Once-daily calcipotriol plus betamethasone dipropionate gel is well tolerated and efficacious for scalp psoriasis in adolescents. CI - (c) 2014 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists. FAU - Gooderham, M AU - Gooderham M AD - SKiN Centre for Dermatology, 743 Lansdowne Street West, Peterborough, ON, Canada, K9J 1Z. FAU - Debarre, J-M AU - Debarre JM FAU - Keddy-Grant, J AU - Keddy-Grant J FAU - Xu, Z AU - Xu Z FAU - Kurvits, M AU - Kurvits M FAU - Goodfield, M AU - Goodfield M LA - eng PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20141022 PL - England TA - Br J Dermatol JT - The British journal of dermatology JID - 0004041 RN - 0 (Dermatologic Agents) RN - 0 (Drug Combinations) RN - 0 (Gels) RN - 143NQ3779B (calcipotriene) RN - 826Y60901U (betamethasone-17,21-dipropionate) RN - 9842X06Q6M (Betamethasone) RN - FXC9231JVH (Calcitriol) SB - IM MH - Administration, Cutaneous MH - Adolescent MH - Betamethasone/administration & dosage/adverse effects/*analogs & derivatives MH - Calcitriol/administration & dosage/adverse effects/*analogs & derivatives MH - Child MH - Dermatologic Agents/administration & dosage/*adverse effects MH - Drug Administration Schedule MH - Drug Combinations MH - Female MH - Gels MH - Humans MH - Male MH - Psoriasis/*drug therapy MH - Scalp Dermatoses/*drug therapy MH - Treatment Outcome PMC - PMC4298245 EDAT- 2014/07/02 06:00 MHDA- 2015/08/19 06:00 CRDT- 2014/07/02 06:00 PHST- 2014/06/16 00:00 [accepted] PHST- 2014/07/02 06:00 [entrez] PHST- 2014/07/02 06:00 [pubmed] PHST- 2015/08/19 06:00 [medline] AID - 10.1111/bjd.13235 [doi] PST - ppublish SO - Br J Dermatol. 2014 Dec;171(6):1470-7. doi: 10.1111/bjd.13235. Epub 2014 Oct 22.