LB1101 Itch and quality of life impact in atopic dermatitis vs bullous pemphigoid

Abstract

Introduction: There is no approved topical prescription medicine to treat molluscum contagiosum (MC). SB206 is an investigational topical product that consists of 2 components; a gel containing berdazimer sodium that releases nitric oxide (NO) when co-administered with a hydrogel. NO, an endogenous small molecule, is known to be an immune modulator as well as an antimicrobial agent. Objective: A Phase 2, 12-week, randomized, vehiclecontrolled ascending dose trial was conducted in patients with MC to evaluate the efficacy and safety of SB206 compared to vehicle (VH). Materials and Methods: Patients 2 years of age were randomized 3:1 (active: vehicle) to ascending, sequential dose groups of SB206. After 30 patients randomized in a dose group completed 2 weeks of treatment, the Data Safety Monitoring Board reviewed unblinded safety and tolerability data and recommended to open the higher dose group. Consequently, 256 patients were randomized into the following dose groups: 47 (4% BID), 48 (8% BID), 47 (12% BID), 48 (12% QD) and 66 (VH). The primary endpoint was the proportion of patients demonstrating complete clearance of MC at Week 12 in the modified intent-to-treat (mITT) population. Results: The following proportion of patients achieved complete clearance at Week 12: 13.2% and 10.6% (4% BID), 41.0% and 33.3% (8% BID), 35.1% and 27.7% (12% BID), 41.9% and 37.5 % (12% QD) and 20.0% and 18.2% (VH) in the mITT and ITT population, respectively. The efficacy signals appeared as early as 2 weeks. There were no SAEs or deaths. The number (%) of patients who discontinued treatment due to AEs were 0 in vehicle group and 7 (4%) in the combined SB206 groups. The majority of AEs were application site reactions. No quantifiable systemic exposure of SB206 was observed. Conclusions: Overall, SB206 was well tolerated and efficacious in treating MC in this study and further studies are warranted.

<p>Depression and Anxiety in Patients with Bullous Pemphigoid: Impact and Management Challenges</p>

“…In another small comparative study, DeGrazia et al found that patients with atopic dermatitis and BP shared similar experience and QoL impact in relation to chronic itch. 16 A questionnaire specific to AIBD was recently developed: the Autoimmune Bullous Disease Quality of Life (ABQOL). It was found to be more sensitive than the Dermatology Life Quality Index (DQLI).…”