LB1096 Results of phase 2 study evaluating the efficacy and safety of SB206, topical berdazimer sodium gel, in subjects with Molluscum Contagiosum T Maeda-Chubachi, E Messersmith, D Hebert, E de Leon and T Reams Novan, Inc, Morris- ville, North Carolina, United States Introduction: There is no approved topical prescription medicine to treat molluscum con- tagiosum (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, vehicle- controlled 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 effi- cacious in treating MC in this study and further studies are warranted. LB1097 The risk of appendicitis, cholecystitis, or diverticulitis in patients with psoriasis E Lee 1 , M Amin 2 , L Duan 3 , A Egeberg 4 and J Wu 5 1 Medicine, University of Hawaii, John A. Burns School of Medicine, Honolulu, Hawaii, United States, 2 Medicine, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 3 Research and Evalu- ation, Kaiser Permanente Southern California, Pasadena, California, United States, 4 Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Gen- tofte, Denmark and 5 Dermatology, Dermatology Research and Education Foundation, Irvine, California, United States The purpose of this study is to determine if patients with psoriasis are at an increased risk of developing appendicitis, cholecystitis, or diverticulitis compared to the general population. A retrospective, population-based, cohort study was performed utilizing data from the Kaiser Permanente Southern California (KPSC) health network during the study period January 1, 2004 through December 31, 2016. Of 1,690,214 KPSC patients eligible for our study, 10,307 met our diagnostic and inclusion criteria for psoriasis. Patients with psoriasis had a 1.16 times greater risk of developing diverticulitis compared to their matched controls (P<0.01). Psori- asis was associated with a higher risk of diverticulitis in both the crude and adjusted models (HR 1.23, 95% CI 1.11-1.35, P<0.001 and HR 1.16, 95% CI 1.05-1.29, P<0.01, respec- tively); however, when separated by disease severity, only patients with severe psoriasis were found to have a higher risk (HR 1.26, 95% CI 1.15-1.61, P<0.001 for adjusted model). There was no significant difference in risk of developing appendicitis or cholecystitis, respectively, among patients with psoriasis compared to their controls. Patients with psoriasis may have an elevated risk of diverticulitis compared to the general population; thus, it may be beneficial for clinicians to evaluate psoriasis patients for risk factors for diverticulitis and subsequently provide counseling to these patients. LB1098 Placebo response in itch and atopic dermatitis studies W Haidari 1 , E Quan 2 , C Patel 3 , LC Strowd 1 and SR Feldman 1,4,5 1 Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston Salem, North Carolina, United States, 2 Dermatology, Virginia Commonwealth University School of Medicine, Richmond, Virginia, United States, 3 Dermatology, Brody School of Medicine at East Carolina University, Greenville, North Carolina, United States, 4 Department of Pa- thology, Wake Forest School of Medicine, Winston Salem, North Carolina, United States and 5 Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston Salem, North Carolina, United States Introduction: The purpose of this study was to assess whether the improvements in itch seen with placebo are due to the use of minimum itch scores as an entry criterion. Methods: A systematic literature review was performed using MEDLINE to find studies that reported the effect of placebo on itch. We then characterized these studies based on whether or not itch was an entry criterion. Itch outcome in placebo arms of studies, quantified using visual analog scale (VAS), was gathered and compared to each other. Results: Placebo response rates of itch in studies where a minimum VAS score was an entry criterion reported greater decreases in mean % VAS change from baseline (-20.9, -28.3, -30.6 for nemolizumab, serlopitant, tra- dipitant, respectively) compared to studies where a minimum VAS score was not an entry criterion (-3.9, 7.1 for apremilast, dupilumab, respectively). Conclusion: Much of the placebo response observed in pruritus clinical trials may be caused by eligibility creep, or the ten- dency for patients to have higher measures of disease severity when determining eligibility in clinical trials, especially when the entry criteria have a subjective component. Chasing apparent beneficial effects of placebos as a treatment strategy may not be worthwhile as these effects may be largely an artifact of study design and not a real improvement in disease severity. LB1099 Placebo response in alopecia studies W Haidari 1 , SR Cohen 1 and SR Feldman 1,2,3 1 Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston Salem, North Carolina, United States, 2 Department of Pathology, Wake Forest School of Medicine, Winston Salem, North Carolina, United States and 3 Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston Salem, North Carolina, United States Introduction: The purpose of this study was to assess the relationship between improvements in alopecia seen with placebo and the method of hair count analysis used to assess the response. Methods: A systematic literature review was performed using MEDLINE to find studies that reported the effect of placebo on alopecia. We then characterized these studies based on the method of hair count analysis. Hair counts in placebo arms of studies, quantified as mean change from baseline in total hair or nonvellus hair count, were gathered and compared. Results: Hair counts increased by 2.3, 50, and 84.3 in 3 minoxidil studies using investigator-counted hair scores. Hair counts decreased by 8 and 21 in 2 studies of finasteride in which hair count analysis was performed using computerized software. Conclusion: The placebo response observed in older alopecia minoxidil studies may have been due to sub- jective assessment. A limitation of our study is that the studies using subjective hair counts were all of topical minoxidil while the studies using objective hair counts were all done with finasteride; we cannot exclude the possibility that vehicle application played some role in the placebo response. Placebo effect may be largely an artifact of study design, not an actual improvement in disease severity, and is unlikely to be an effective treatment strategy. LB1100 Healthy Skin for Everyone: One-year data from a community-based skin cancer education program in an underserved population NA Ufkes 4 , A Jacobsen 1 , J Maisonet 2 and J Strasswimmer 2,3 1 Dermatology, University of Minnesota, Minneapolis, Minnesota, United States, 2 The Caridad Center, Boynton Beach, Florida, United States, 3 Dermatology Medical Missions Inc., Delray Beach, Florida, United States and 4 College of Medicine, Medical University of South Carolina, Charleston, South Carolina, United States “Healthy Skin for Everyone”, or “Piel Saludable Para Todos”, is a community-based initiative to address rising rates of skin cancer in minority populations accompanied by higher mortality and lack of evidence-based interventions. We previously enrolled 114 Spanish-speaking adults from a non-profit clinic to participate in a 45-minute workshop on skin cancer pre- vention led by trained community health workers followed by a 12-week text-messaging program. These are the results of a one-year follow up to assess the durability of behavioral changes. Participants completed pre- and post-test assessments followed by telephone surveys at 3 and 12 months. We previously showed this was the first time 92% (n¼104) had ever received information about skin cancer. Eighty-five of 114 (75.6%) responded at 12 months. We measured sun-protective behaviors on a 5-point scale (1 being “never” and 5 “always”), comparing pre-test to 3-month scores, then 3-month to 12-month scores. Sunscreen use increased from an average score of 2.20 (SD¼1.22) pre-workshop, to 3.52 at 3-months (SD¼1.24, p<0.001) and 3.34 at 12-months (SD¼1.42, p¼0.02). Long-sleeve shirt use rose from 2.42 (SD¼1.00) pre-workshop, to 3.22 at 3-months (SD¼1.35, p¼0.02) and 3.30 at 12- months (SD¼1.67, p¼0.60). Hat-use increased from 2.83 (SD¼1.42) pre-workshop, to 3.69 at 3-months (SD¼1.53, p¼0.003) and 3.55 at 12-months (SD¼1.65, p¼0.19). Participants who had ever examined their skin for suspicious lesions increased from 8 (14.3%) pre-workshop to 61 (53.5%) at 12-months. Participants in “Healthy Skin for Everyone” engaged in significantly higher rates of sun-protective behaviors following the intervention and maintained these behaviors after 12-months, showing this can be an effective program in a Spanish-speaking, underserved community. LB1101 Itch and quality of life impact in atopic dermatitis vs bullous pemphigoid TM DeGrazia, y liu, B Bradley, C Thompson, S Francois, S Chisolm, SC Chen and RJ Feldman Emory University, Atlanta, Georgia, United States Atopic dermatitis (AD) and bullous pemphigoid (BP) are inflammatory skin diseases in which patients often report intense pruritus and significant quality of life (QOL) impact. Although they have differences in classical presentation (eczematous eruption versus urticaria and blisters) and population characteristics (young-to middle aged persons vs. elderly), early stages of BP can appear similar to AD clinically and histologically. We wanted to explore whether there were significant similarities or differences in pruritus characteristics and QOL impact. Our observational cohort study included 65 patients with either AD (34) or BP (31) and a history of chronic pruritus. Our cohort was mostly female (66%), mean ages 47.1 (AD) and 72.2 (BP), mean severity scores 38.5 (AD, EASI) and 19.4 (BP, BPDAI). We assessed QOL and itch severity using the QOL from pruritus (ItchyQoL) and cartoon-annotated 11-point rating scale (ItchyQuant) questionnaires. The mean total ItchyQoL scores for AD and BP were 48.8 (mild) and 44.4 (mild), respectively. Furthermore, the ItchyQoL totals were subdivided into symptom, function and emotional impact components. We did not find meaningful differences between total or category itch scores in AD vs. BP. The only significant differences between itch characteristics were the aggravation of skin by seasonal/temperature changes and feelings of self-consciousness (p¼0.002), both of which were higher reported by patients with AD. Itch severity was taken into account using the ItchyQuant scale. Considering a 0-10 severity scale, the mean scores for AD and BP were 5.23 and 5.90, respectively, which was also not found to be significantly different. This study was limited by the relatively small sample size. To our knowledge, no other study has sought to compare itch directly between different chronic pruritic diseases. Given the similarity in patient-reported itch outcomes, patients with chronic itch may have shared experiences and quality of life impact, warranting further research into possible commonalities of their underlying disease pathways. ABSTRACTS | Interventional Studies, Clinical and Patient Reported Outcomes B14 Journal of Investigative Dermatology (2019), Volume 139