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Aars Hot Topics Member Newsletter AARS HOT TOPICS MEMBER NEWSLETTER American Acne and Rosacea Society 201 Claremont Avenue • Montclair, NJ 07042 (888) 744-DERM (3376) • [email protected] www.acneandrosacea.org Like Our YouTube Page TABLE OF CONTENTS We encourage you to Industry News invite your colleagues and Cosmetic makers harness microbiome to help treat skin conditions ......................... 2 patients to get active in Foamix plans third phase 3 trial for minocycline foam to treat acne with NDA ......... 2 the American Acne & BPX-01 topical minocycline shows efficacy in treating acne ..................................... 3 Rosacea Society! Visit New Medical Research www.acneandrosacea.org Non-ablative fractional laser-assisted daylight photodynamic therapy with .............. 3 to become member and The Potential of Triterpenoids from Loquat Leaves (Eriobotrya japonica) ................ 3 donate now on Factors affecting the course and severity of adult acne. Observational cohort ......... 4 www.acneandrosacea.org/ Acne conglobata in a long-term survivor with trisomy 13, accompanied ................... 4 donate to continue to see Pharmacological PPARγ modulation regulates sebogenesis and inflammation ....... 5 a change in acne and Effects of Helicobacter pylori treatment on rosacea: A single-arm clinical ................ 5 rosacea. Mutations in γ-secretase subunit-encoding PSENEN underlie Dowling-Degos ........ 6 Isotretinoin as a Possible Environmental Trigger to Autoimmunity ........................... 6 Acne RA-1,2, a novel UV-selective face cream for patients with acne: ..................... 7 Clinical Reviews Development of an atrophic acne scar risk assessment tool .................................... 7 Updating the diagnosis, classification and assessment of rosacea by ...................... 8 Spironolactone for the Treatment of Acne: A 4-Year Retrospective Study ............... 8 Dermatological comorbidity in psoriasis: results from a large-scale cohort ............... 8 Skin needling as a treatment for acne scarring: An up-to-date review of .................. 9 The effect of probiotics on immune regulation, acne, and photoaging ...................... 9 Propionibacterium acnes and antimicrobial resistance in acne ................................. 9 Understanding the role of Propionibacterium acnes in acne vulgaris: ..................... 10 A Review of hormone-based therapies to treat adult acne vulgaris in women ........ 10 Oral Contraceptives for Acne Treatment: US Dermatologists‟ Knowledge ............. 11 Botanicals With Dermatologic Properties Derived From First Nations Healing ....... 11 Patient Communication / Counseling How does acne affect self-confidence? ................................................................... 11 The Role of Skin Care in Optimizing Treatment of Acne and Rosacea ................... 12 Psychological Status and Quality of Life in Acne Patients Treated with Oral .......... 12 Updates in the understanding and treatments of skin & hair disorders ................... 13 Rosacea ................................................................................................................... 13 Feelings of stigmatization in patients with rosacea .................................................. 14 Page 2 Industry News Cosmetic makers harness microbiome to help treat skin conditions. May 10, 2017. News Medical. http://www.news-medical.net/news/20170510/Cosmetic-makers-harness-microbiome-to-help-treat-skin- conditions.aspx Cosmetic companies have started developing and selling products designed to harness the skin microbiome to help treat a range of skin conditions from acne to eczema. Skeptics, however, warn that touting such an approach is premature because scientists are still working to understand the bacteria that live on our skin and interact with it. The cover story in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society, scopes out the scene. Marc S. Reisch, a senior correspondent at C&EN, reports that cosmetic firms, large and small, are increasingly interested in how the microbiome affects skin health. To see if they can bottle some of its potential benefits, they're researching skin bacteria and active ingredients to promote helpful microbes and discourage harmful ones. However, skeptics caution that scientists don't yet have a baseline picture of what a healthy skin microbiome would look like, much less know how to achieve a healthy bacterial community. Undeterred by the limited body of skin microbiome knowledge, at least a couple of companies have already marketed bacteria- based product lines. Yun Probiotherapy says its line incorporates "friendly" bacteria to help correct skin microbe imbalances. AOBiome based its product on results from a study examining why horses roll in the dirt. They found that bacteria in the dirt produce compounds that help regulate inflammation and that could be beneficial to skin. Cosmetic heavyweights, including Johnson & Johnson, Procter & Gamble and L'Oréal, are also developing microbiome-based products. Source: https://www.acs.org/content/acs/en/pressroom/presspacs/2017/acs-presspac- may-10-2017/cosmetic-makers-bottle-bacteria-for-beautiful-skin.html Foamix plans third phase 3 trial for minocycline foam to treat acne with NDA as goal. May 10, 2017. Healio Dermatology News. http://www.healio.com/dermatology/acne/news/online/%7Be854b82c-dccf-4b69-8257- 95b71108a864%7D/foamix-plans-third-phase-3-trial-for-minocycline-foam-to-treat-acne-with-nda-as-goal Foamix Pharmaceutical recently announced that based on the results of its first two phase 3 trials, it will conduct a third U.S. phase 3 trial of FMX101 to treat patients with moderate-to-severe acne. The trial is slated to begin mid- year, and if results are positive, the trial could form the basis of a new drug application (NDA) for FMX101 (minocycline foam 4%), which the company plans to submit in the second half of 2018, according to a news release from Foamix. “The totality of the clinical efficacy results from FMS101, including the further analysis we conducted of the phase 3 data, are positive,” Dov Tamarkin, PhD, CEO of Foamix, stated in the release. “Inconsistent results were noted in only one of the efficacy endpoints and the product appears to be safe and well tolerated. Based on our analysis of the efficacy results from Trials 04 and 05, we plan to conduct a third trial to validate the results, with the same co-primary endpoints and enrollment criteria but with a substantially increased sample size.” Target patient enrollment for the new trial is 1,500, and patients will be randomized to receive either FMX101 or vehicle foam once daily for 12 weeks. Mean change from baseline in the inflammatory lesion count and proportion of patients with Investor‟s Global Assessment scores of “clear or “almost clear” with improvement of at least two grades from baseline are co-primary endpoints, according to the release. Foamix reported that the trial is to be conducted at approximately 30 clinical sites in the U.S. Reference: www.foamixpharma.com American Acne & Rosacea Society (AARS) Hot Topics May 1 – May 15, 2017 Page 3 BPX-01 topical minocycline shows efficacy in treating acne. May 4, 2017. Healio Dermatology News. http://www.healio.com/dermatology/acne/news/online/%7B00e5c011-b428-4b70-a9cd-6c5cc244be06%7D/bpx-01- topical-minocycline-shows-efficacy-in-treating-acne BioPharmX announced that BPX-01 showed efficacy in both 1% and 2% doses in treating moderate-to-severe acne in children and adults. BPX-01 is a solubilized topical minocycline gel product candidate for the treatment of moderate-to-severe acne. In meeting a phase 2b study‟s primary endpoint, both 1% and 2% doses of BPX-01 significantly reduced non-nodular inflammatory acne lesions when compared to vehicle, according to a news release from BioPharmX. The randomized, double-blind study measured the efficacy and safety of BPX-01 in two concentrations and vehicle in treating 226 patients, aged 9 to 40 years, with moderate-to-severe inflammatory, non- nodular acne vulgaris. The BPX-01 2% treatment cohort (n = 72) had a reduction of 15.4 in absolute mean change in number of acne lessons at week 12 compared to baseline (P = 0.022 compared to vehicle), while the BPX-01 1% cohort (n = 73) had a reduction of 15.5 compared to baseline (P = .037 compared to vehicle) and vehicle cohort (n = 74) had a reduction of 11.3 compared to baseline. The study‟s secondary endpoint was the proportion of patients with at least a two-grade reduction in Investor‟s Global Assessment to clear “0” or almost clear “1.” In the BPX-01 2% cohort, 22.7% met the secondary endpoint, while 16% of the BPX-01 1% cohort and 17.1% of vehicle also met the secondary endpoint. However, the results were not statistically significant. BioPharmX has not yet analyzed the safety data from the phase 2b study, but there were no serious adverse events related to study treatment reported to the company by the investigators, according to the release. Reference: www.biopharmx.com New Medical News Non-ablative fractional laser-assisted daylight photodynamic therapy with topical methyl aminolevulinate for moderate to severe facial acne vulgaris: Results of a randomized and comparative study. Kim TI, Ahn HJ, Kang IH, et al. Photodermatol Photoimmunol Photomed. 2017 May 13. doi: 10.1111/phpp.12312. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28500784 BACKGROUND: Photodynamic therapy (PDT) has been reported as an effective alternative treatment for patients with acne.
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