Summary

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• This summary is based on the review of three randomized controlled trial(s). ^[1-3]
• Primary Outcome - Complete Lesion Clearance: Berdazimer showed a clearance rate of 29.1% in the atopic dermatitis (AD)- subgroup compared to 18.9% for the vehicle (odds ratio (OR): 1.8, 95% confidence interval (CI), 1.4-2.4). In the B-SIMPLE4 trial, Berdazimer had a 32.4% clearance rate versus 19.7% for the vehicle (Absolute difference: 12.7%, OR: 2.0, 95% CI, 1.5-2.8, P < .001).
• Patient and Investigator Perceptions: At Week 12, 82% of participants treated with Berdazimer reported "very much improved" or "much improved" versus 60% of those treated with the vehicle.
• Reduction in Lesion Count: Participants experienced a mean reduction of 18 lesions, representing a 76% decrease, with 23 out of 30 participants reporting the change as meaningful even without complete clearance.
• Application-site pain was reported in 21.6% of Berdazimer-treated AD+ patients and 4.1% of the general Berdazimer-treated population, compared to 11.9% in the vehicle-treated AD+ patients.
• Adverse events leading to discontinuation occurred in 4.1% (18 patients) of Berdazimer-treated patients versus 0.7% (3 patients) in the vehicle group.
• AD+ Subgroup (with atopic dermatitis): Berdazimer showed a slightly better but not statistically significant complete lesion clearance compared to vehicle (35.0% vs. 27.4%; OR: 1.3, 95% CI, 0.7-2.5), while also having a higher incidence of application-site pain and dermatitis.
• AD- Subgroup (without atopic dermatitis): Berdazimer achieved a higher complete lesion clearance compared to the vehicle (29.1% vs. 18.9%; OR: 1.8, 95% CI, 1.4-2.4), with fewer safety concerns.