Open-label, uncontrolled clinical investigation of the performance and safety of a foam containing a hyaluronic acid-derived biopolymer and humectants for management of dermatitis in adults

BACKGROUND: Atopic (AD) and contact (CD) dermatitis can interfere with everyday function. Non-prescription topical formulations can aid AD/CD symptom relief and alleviate exacerbation. In this post-marketing clinical investigation, performance and safety of a foam containing sodium butyroyl/formoyl hyaluronate, glycerol and panthenol was investigated. METHODS: This multicenter, open-label, uncontrolled, post-marketing clinical follow-up investigation included 37 adults with mild-to-moderate AD, irritant CD (ICD) or allergic CD (ACD). The foam was applied twice-a-day to affected areas for 42 days and assessed on Days 14, 28 and 42 using the Investigators Global Assessment score (ICA; rated 0-5); the Eczema Area and Severity Index (EASI); the Dermatology Life Quality Index (DLQI); visual analogue scales (VAS) for pruritus, scratching, pain and burning; investigator's global evaluation of performance and participant overall treatment acceptability. Primary endpoint was IGA score change from baseline to Day 28. Success was prespecified as an IGA score decrease ≥1. RESULTS: At Day 28, mean IGA score decreased from baseline by 1.11 (standard deviation 0.68) with treatment success in 88.6% of participants (P<0.0001). At Days 14/42, 52.8%/94.3% (P<0.0001) showed an improved IGA. Progressive improvements were shown in EASI, VAS and DLQI scores to Day 42, significant at each timepoint (P<0.001). For participant and investigator performance evaluation, 94.3% reported improvement. Most participants rated the foam's acceptability as "very much satisfied" or "satisfied." The foam was generally well-tolerated. CONCLUSIONS: Use of a foam containing sodium butyroyl/formoyl hyaluronate, glycerol and panthenol led to significant alleviation of AD, ICD or ACD and decreased associated quality of life impacts.