Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials
Background: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes.Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability...
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Taylor & Francis Group
2025-12-01
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| Series: | Journal of Dermatological Treatment |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/09546634.2024.2444489 |
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| author | Linda Stein Gold James Del Rosso Benjamin D. Ehst Matthew J. Zirwas Lawrence J. Green Philip M. Brown David S. Rubenstein Stephen C. Piscitelli Anna M. Tallman |
| author_facet | Linda Stein Gold James Del Rosso Benjamin D. Ehst Matthew J. Zirwas Lawrence J. Green Philip M. Brown David S. Rubenstein Stephen C. Piscitelli Anna M. Tallman |
| author_sort | Linda Stein Gold |
| collection | DOAJ |
| description | Background: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes.Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck.Results: 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0–1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3–0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2–0.4 (burning/stinging) and 0.6–0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0–0.3 versus 0–1.0).Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas.Clinicaltrials.gov numbers NCT05014568, NCT05032859 |
| format | Article |
| id | doaj-art-c9d8f63fc5a24ca388e73879e00d532a |
| institution | Kabale University |
| issn | 0954-6634 1471-1753 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Dermatological Treatment |
| spelling | doaj-art-c9d8f63fc5a24ca388e73879e00d532a2025-01-12T23:29:49ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532025-12-0136110.1080/09546634.2024.2444489Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trialsLinda Stein Gold0James Del Rosso1Benjamin D. Ehst2Matthew J. Zirwas3Lawrence J. Green4Philip M. Brown5David S. Rubenstein6Stephen C. Piscitelli7Anna M. Tallman8Henry Ford Health System, Detroit, MI, USAJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, USAOregon Medical Research Center, Portland, OR, USADOCS Dermatology, Bexley, OH, USAThe George Washington University School of Medicine and Health Sciences, Washington, DC, USADermavant Sciences, Inc., Morrisville, NC, USAFormerly of Dermavant Sciences, Inc, Morrisville, NC, USADermavant Sciences, Inc., Morrisville, NC, USADermavant Sciences, Inc., Morrisville, NC, USABackground: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes.Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck.Results: 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0–1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3–0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2–0.4 (burning/stinging) and 0.6–0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0–0.3 versus 0–1.0).Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas.Clinicaltrials.gov numbers NCT05014568, NCT05032859https://www.tandfonline.com/doi/10.1080/09546634.2024.2444489Tapinarof cream 1% once dailyaryl hydrocarbon receptor agonistatopic dermatitisphase 3 trialsadults and childrenlocal tolerability scale |
| spellingShingle | Linda Stein Gold James Del Rosso Benjamin D. Ehst Matthew J. Zirwas Lawrence J. Green Philip M. Brown David S. Rubenstein Stephen C. Piscitelli Anna M. Tallman Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials Journal of Dermatological Treatment Tapinarof cream 1% once daily aryl hydrocarbon receptor agonist atopic dermatitis phase 3 trials adults and children local tolerability scale |
| title | Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| title_full | Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| title_fullStr | Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| title_full_unstemmed | Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| title_short | Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| title_sort | tapinarof cream 1 once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials |
| topic | Tapinarof cream 1% once daily aryl hydrocarbon receptor agonist atopic dermatitis phase 3 trials adults and children local tolerability scale |
| url | https://www.tandfonline.com/doi/10.1080/09546634.2024.2444489 |
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