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- Title
301 Tapinarof cream 1% once daily for the treatment of extensive atopic dermatitis in adolescents and children: 4-week maximal use trial.
- Authors
Paller, Amy; Hebert, Adelaide A.; Jett, John E.; Brown, Philip M.; Rubenstein, David S.; Piscitelli, Stephen C.
- Abstract
There is a need for efficacious non-steroidal topical ther - apies for atopic dermatitis (AD) without restrictions relat - ing to duration, the extent of use and application sites. Tapinarof (VTAMA®; Dermavant Sciences, Inc., USA) is a first-in-class, non-steroidal, topical, aryl hydrocarbon recep - tor agonist approved by the Food and Drug Administration for the treatment of plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age and for AD in adults and children down to 2 years of age. Tapinarof cream 1% once daily (QD) demonstrated significant efficacy vs. vehicle at 12 weeks and was well tolerated in adults and adolescents and with moderate to severe AD in a previously reported phase 2b trial (NCT02564055). To assess the safety, tolerability, pharmacokinetics (PK) and efficacy of tapinarof cream 1% QD in adolescents and children with extensive AD. In this open-label, maximal use, phase 2 trial (NCT05186805), adolescents and children, aged 2–17 years, with a clinical diagnosis of AD, a validated Investigator Global Assessment in Atopic Dermatitis™ (vIGA-AD™) score ≥3, and percent body surface area (%BSA) involvement of ≥ 25% for ado - lescents (12–17 years) or ≥35% for children (2–11 years) were assigned tapinarof cream 1% QD for 27 days. Primary endpoints include adverse events, mean investigator-as - sessed local tolerability scores (overall and sensitive areas) and PK parameters. Secondary endpoints include a change in vIGA-AD™, Eczema Area Severity Index (EASI), %BSA affected, and Peak Pruritus-Numeric Rating Scale scores at each trial visit. Eligible patients completing this trial have the option to enrol in an open-label, long-term extension trial (NCT05142774) to receive up to an additional 48 weeks of tapinarof cream 1% QD treatment. Overall, 36 patients aged 2–17 years were enrolled at nine sites in the US and Canada. Of these patients, equal proportions (33.3% [12/36]) were young children (2–6 years), children (7–11 years) and ado - lescents (12–17 years); 66.7% (24/36) were male and mean age (standard deviation [SD]) was 8.9 (4.9) years. At base - line, 77.8% (28/36) had a vIGA-AD™ score of 3 (moderate) and 8/36 (22.2%) had a score of 4 (severe). At baseline, the mean (SD) %BSA affected was 52.4% (19.1%), 42.0% (10.0%) and 33.9% (8.6%) for young children, children and adolescents, respectively. The overall mean (SD) EASI score was 23.8 (9.2). This trial will assess the safety, tolerability, PK and efficacy of tapinarof cream 1% QD in 36 adolescents and children down to 2 years of age with extensive, moder - ate-to-severe AD.
- Subjects
UNITED States. Food &; Drug Administration; ATOPIC dermatitis; TEENAGERS; BODY surface area; ECZEMA
- Publication
British Journal of Dermatology, 2023, Vol 188, pii3
- ISSN
0007-0963
- Publication type
Article
- DOI
10.1093/bjd/ljac140.005