PMID- 33258536 OWN - NLM STAT- MEDLINE DCOM- 20210524 LR - 20210524 IS - 1529-8019 (Electronic) IS - 1396-0296 (Linking) VI - 34 IP - 1 DP - 2021 Jan TI - Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta-analysis of randomized placebo-controlled trials. PG - e14609 LID - 10.1111/dth.14609 [doi] AB - To systematically and meta-analytically pool evidence from randomized placebo-controlled trials that examined the efficacy and safety of topical clascoterone cream in patients with acne vulgaris. Four databases were screened from inception to 10 October 2020. Included studies were assessed for risk of bias. Efficacy outcomes included investigator's global assessment (IGA) treatment success and absolute change in inflammatory lesion counts (ILCs) and noninflammatory lesion counts (NILCs). Safety outcomes included the proportion of patients with any treatment-emergent adverse event (TEAE) as well as incidence of any TEAE, serious adverse events (AEs), AEs related to study drug, AEs leading to study drug discontinuation, nasopharyngitis, headache, oropharyngeal pain, and vomiting. Dichotomous data were analyzed using the risk ratio (RR) and 95% confidence interval (95% CI) whereas continuous data were analyzed using the mean difference (MD) and 95% CI. Review Manager Software version 5.4.1 was used for statistical analysis. Five clinical trials, comprising 2457 patients (1357 and 1100 patients received clascoterone and placebo, respectively) were included. Studies revealed an overall low risk of bias. Clascoterone significantly increased IGA success rates (RR = 2.87, 95% CI [2.11, 3.89], P < .001) and decreased NILCs (MD = -5.64, 95% CI [-8.41, -2.87], P < .01) without substantially impacting the ILCs (MD = -1.82, 95% CI [-5.06, 1.43], P = .27). No significant differences were noted between both groups for all safety outcomes, except for nasopharyngitis which was significantly lower in the clascoterone group (RR = 0.47, 95% CI [0.27, 0.83], P = .01). Topical clascorterone cream is safe and effective in the treatment of acne vulgaris. CI - (c) 2020 Wiley Periodicals LLC. FAU - Alkhodaidi, Shrooq Tail AU - Alkhodaidi ST AD - Department of Dermatology, King Abdulaziz Hospital, Makkah, Saudi Arabia. FAU - Al Hawsawi, Khalid Ali AU - Al Hawsawi KA AD - Department of Dermatology, King Abdulaziz Hospital, Makkah, Saudi Arabia. FAU - Alkhudaidi, Ishraq Tail AU - Alkhudaidi IT AD - College of Medicine, Taif University, Taif, Saudi Arabia. FAU - Magzoub, Duha AU - Magzoub D AD - School of Public Health, The University of Memphis, Memphis, Tennessee, USA. FAU - Abu-Zaid, Ahmed AU - Abu-Zaid A AUID- ORCID: 0000-0003-2286-2181 AD - College of Medicine, Alfaisal University, Riyadh, Saudi Arabia. AD - Department of Pharmacology, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, Tennessee, USA. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20201211 PL - United States TA - Dermatol Ther JT - Dermatologic therapy JID - 9700070 RN - 0 (Propionates) RN - WDT5SLP0HQ (Cortodoxone) RN - XN7MM8XG2M (Clascoterone) SB - IM MH - *Acne Vulgaris/diagnosis/drug therapy MH - Cortodoxone/analogs & derivatives MH - Humans MH - *Propionates MH - Randomized Controlled Trials as Topic MH - Skin Cream OTO - NOTNLM OT - CB-03-01 OT - Clascoterone OT - acne vulgaris OT - cortexolone 17alpha-propionate EDAT- 2020/12/02 06:00 MHDA- 2021/05/25 06:00 CRDT- 2020/12/01 08:38 PHST- 2020/10/22 00:00 [received] PHST- 2020/11/21 00:00 [accepted] PHST- 2020/12/02 06:00 [pubmed] PHST- 2021/05/25 06:00 [medline] PHST- 2020/12/01 08:38 [entrez] AID - 10.1111/dth.14609 [doi] PST - ppublish SO - Dermatol Ther. 2021 Jan;34(1):e14609. doi: 10.1111/dth.14609. Epub 2020 Dec 11.