title: Antipruritic hydrogel for the treatment of atopic dermatitis: an open-label pilot study.
abstract: Atopic dermatitis (AD) is the most common chronic inflammatory skin disease in industrialized nations. The efficacy and tolerability of Atrapro (RD047-26) antipruritic hydrogel was evaluated in 17 adult participants with mild to moderate AD with associated pruritus. The antipruritic hydrogel was applied 3 times daily to the affected areas of the body, and participants were evaluated on days 3, 7, and 14 (end of study). There were 3 efficacy end points: investigator global assessment (IGA), investigator pruritus assessment (IPA), and participant itch assessment (PIA). All 3 efficacy end points were met and showed a statistically significant improvement in the mean score from baseline to day 14 (P < .001). The mean IGA score improved 43% from a baseline score of 2.7 to a day 14 score of 1.53 (P < .001) on a 5-point scale (0 = clear; 4 = severe). The severity of pruritus decreased in 88% (15/17) of participants from baseline to day 14 based on the IPA and 82% (14/17) of participants based on the PIA. Most participants (82% [14/17]) experienced relief from itching by day 3, and this improvement remained consistent at each of the follow-up office visits. The only adverse event (AE) was mild postapplication skin dryness, which was reported by 59% (10/17) of participants and resolved with increased use of emollients. Based on these promising results, further research on the antipruritic hydrogel is warranted.
authors.affiliation: Department of Dermatology, Duke University School of Medicine, Durham, North Carolina, USA. zdraelos@northstate.net
authors.forename: Zoe Diana
authors.initials: ZD
authors.lastname: Draelos
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000982:Antipruritics / Q000009:adverse effects / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D020100:Hydrogels / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011537:Pruritus / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000982:Antipruritics; C576713:Atrapro; D020100:Hydrogels