Author Interviews, Dermatology, University of Pennsylvania / 08.07.2019 Interview with: John Barbieri, MD, MBA Hospital & Health Care University of Pennsylvania What is the background for this study? Would you briefly describe the type of acne treated with Isotretinoin? Response: Isotretinoin is often used to treat moderate to severe acne or acne that has been unresponsive to other treatments. It is also used for patients with scarring acne. While highly effective for acne, due to concerns about medication related side-effects, patients are often monitoring with frequent blood tests, sometimes up to once per month. However, there have been several studies over the past two decades questioning the value of these frequent blood tests for patients on isotretinoin for acne. The purpose of this study was to examine whether blood test monitoring has been decreasing over time in response to these studies. We also evaluated the frequency of blood test abnormalities for patients being treated with isotretinoin. (more…)
Author Interviews, Dermatology / 28.05.2019 Interview with: Venkateswarlu (Venkat) NelabhotlaPresident & Board MemberVyome Therapeutics Inc., Venkateswarlu (Venkat) Nelabhotla President & Board Member Vyome Therapeutics Inc., What is the background for this study? Response: There are only a handful of antibiotics that are approved for use against the bacterial strain P.acnes that causes acne vulgaris. Because of the lack of new antibiotic treatment options, similar antibiotics are overused resulting in 1 out of 3 patients developing resistance against treatment, ultimately causing a decline in response rates. There is a clear unmet medical need for these patients; currently, patients do not have access to topical antibiotic treatments capable of an effective response without generating resistance. This study was designed to test the efficacy of VB-1953 in such moderate to severe acne patients, who were carrying resistant acne-causing bacteria and had failed to respond to currently approved antibiotics. VB-1953, a bactericidal topical gel formulated antibiotic, differs from these older generation antibiotics in its novel mechanism of action, through which it can kill both sensitive as well as resistant bacteria, while also reducing inflammation . The earlier generation of antibiotics, including treatments like clindamycin, are bacteriostatic in action, i.e. they merely prevent the growth of acne-causing bacteria. VB-1953 is the first bactericidal antibiotic for the treatment of acne that kills acne-causing bacteria. VB-1953 also retards the development of resistance, and reduces inflammation associated with acne via an independent immunomodulatory effect.  (more…)
Author Interviews, Dermatology, Weight Research / 01.05.2019 Interview with: Igor Snast, MD Department of Dermatology Rabin Medical Center–Beilinson Hospita Israel. What is the background for this study? What are the main findings? Response: Acne is the most common skin disorder among adolescents. Obesity has been suggested to promote acne, however various studies evaluating the relationship between obesity and acne have yielded contradictory outcomes. Our population-based study demonstrates that overweight, obese and severely obese youths have decreased odds of having acne (20%, 35% and 50% respectively) compared to normal-weight subjects. (more…)
Author Interviews, Dermatology, Microbiome, Pediatrics, UCSD / 30.04.2019 Interview with: Dr. Jusleen Ahluwalia MD Second-year Dermatology resident University of California, San Diego What is the background for this study? What are the main findings?  Response: Preadolescence is an interesting stage during which changes in microbial diversity can coincide with the development of acne. This study is the largest assessment of preadolescent acne microbiome in the literature to date. In this study, we found that early acne in preadolescent females is characterized by an abundance of Streptococcus mitis, while later stages are characterized by a predominance of Cutibacterium acnes (formerly known as Propionibacterium acnes).   (more…)
Author Interviews, Dermatology, Weight Research / 15.04.2019 Interview with: Igor Snast, MD Department of Dermatology Rabin Medical Center–Beilinson Hospital Israel What is the background for this study? What are the main findings? Response: Acne is the most common skin disorder among adolescents. Obesity has been suggested to promote acne, however various studies evaluating the relationship between obesity and acne have yielded contradictory outcomes. Our population-based study demonstrates that overweight, obese and severely obese youths have decreased odds of having acne (20%, 35% and 50% respectively) compared to normal-weight subjects. (more…)
Author Interviews, Dermatology, Pharmaceutical Companies / 05.03.2019 Interview with: Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist Research Director and Principal Investigator Del Rosso Dermatology Research Center, Las Vegas, NV Galderma Consultant What is the background for this study? What are the main findings?
  • The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
  • Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
  • The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
  • 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
  • Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
  • Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.
Author Interviews, Dermatology, JAMA, Johns Hopkins, Microbiome / 15.02.2019 Interview with: Luis Garza, MD-PhD Associate Professor Department of Dermatology Johns Hopkins School of Medicine Baltimore, MD 21287 What is the background for this study? What are the main findings?  Do you think these findings would be similar with other antibiotics (oral or topical) or with isotretinoin for acne? Response: We prescribe antibiotics frequently for acne. We certainly know it affects our normal and abnormal bacteria on our skin. But we don’t fully understand how well or not people recover from antibiotics.  (more…)
Author Interviews, Dermatology, JAMA / 26.11.2018 Interview with: Dr Tarun Narang MD MNAMS Department of Dermatology, Venereology, and Leprology Postgraduate Institute of Medical Education and Research Chandigarh, India What is the background for this study? Response: Acne is one of the most common dermatological problem for which the patients seek medical care. Post acne scarring is a complication of acne, resulting in long lasting physical disfigurement and low self esteem in the affected individuals. Even though there are various methods like microneedling, chemical peeling, cryorolling and ablative lasers to address the post acne atrophic scarring, these procedures are office based hence physician dependent. A home based treatment modality that can treat post acne atrophic scarring with a comparable efficacy to the procedural modalities of treatment will be beneficial to the patient. Our study was done to assess the efficacy of a topical modality of treatment, tazarotene gel, 0.1% in the management of post acne atrophic scarring in comparison to an established method, the microneedling. (more…)
Author Interviews, Dermatology, Pharmaceutical Companies / 09.10.2018 Interview with: foamixDavid Domzalski CEO Foamix Pharmaceuticals What is the background for this study?  How does FMX101 differ from other treatment for acne, ie benzoyl peroxide, topical clindamycin etc?  Response: This study measures the safety and efficacy of a topical foam formulation of the antibiotic minocycline, for the treatment of moderate-to-severe acne. Minocycline is one of the most commonly used products for the treatment of acne, but is currently only available in an oral dosage form. Significant side effects are associated with oral minocycline, including GI upset, photosensitivity, headaches, dizziness, and other potential effects on the CNS.  In addition to the side effects associated with oral minocycline, many currently available topical acne medications contain ingredients which can be drying and irritating to the skin.  These side effects can be frustrating to patients and potentially impact overall compliance to their treatment regimen.  The study addresses important unmet needs in dermatology to determine whether providing patients with a topical dosage form of minocycline may have potential advantages over existing products. In our first two Phase 3 clinical studies, >95% of facial local tolerability signs and symptoms were classified as “none” or “mild,” including dryness, erythema and itching.  Also, our topical minocycline foam, FMX101, is a natural triglyceride-based vehicle that does not contain ingredients that serve as  primary irritants or surfactants.  We believe that FMX101, if approved, would be the first topical minocycline available for the treatment of acne and provide a novel and much needed treatment option for patients who suffer from the physical and psycho-social effects of acne. (more…)
Author Interviews, Dermatology, Vaccine Studies / 30.08.2018 Interview with: Eric Huang, PhD Professor, Department of Dermatology University of California, San Diego What is the background for this study? To whom would the vaccine be targeted?  Affected individuals?  Patients with strong family history? Resistant acne cases? Response: The background for this study is to develop vaccines to replace the antibiotics which may induce resistant bacteria. Preventive acne vaccines will be used for injection into elementary students to prevent the acne development when they become teenagers. Therapeutic acne vaccines using monoclonal antibodies will be used for those patients who already have acne vulgaris. Both patients with strong family history and resistant acne cases are highly recommended to use when the acne vaccines are available.   (more…)
Author Interviews, Depression, Dermatology / 09.02.2018 Interview with: “Young man with acne” by Sergey Sudeykin (Russian, Smolensk 1882–1946 Nyack) via The Metropolitan Museum of Art is licensed under CC0 1.0Isabelle Vallerand, Ph.D. Epidemiologist, MD Student Dept. of Community Health Sciences Cumming School of Medicine University of Calgary What is the background for this study? What are the main findings? Response: Over the past few years, there have been numerous reports that an acne drug called isotretinoin (Accutane) has been linked to psychiatric disorders. We recently published a systematic review on this topic and did not find an increased risk of psychiatric disorders among people treated with isotretinoin, so we wondered if acne itself may be contributing to mental illness. While it is well known that acne can have negative effects on mood, we wanted to assess if there was an increased risk of true clinical depression using medical records data. Therefore, we conducted the current study and found that acne increased the risk of developing clinical depression by 63% in the first year following an acne diagnosis and that this risk remained elevated for 5 years after the initial acne diagnosis. (more…)
Author Interviews, Dermatology / 23.03.2017 Interview with: Usha Nagavarapu, PhD Senior director of preclinical drug development BioPharmX What is the background for this study? What are the main findings? Response: Acne vulgaris is a complex chronic inflammatory disease known to be linked with P. acnes and can have profound social and psychological effects. Though a number of treatments exist, there is promise of a long-term benefit for acne patients. BioPharmX’s in vitro and in vivo studies have revealed that a low-dose, topical 1% minocycline gel (BPX-01) provided a localized and targeted delivery of adequate minocycline to the epidermis and pilosebaceous units that can potentially limit systemic exposure and may reduce treatment related side effects. At the intended clinical dose, toxicity and safety animal studies found that BPX-01 was well tolerated with no significant local or systemic toxic effects. A comparative animal study with oral minocycline demonstrated that topical application of minocycline can limit systemic exposure while delivering sufficient minocycline to the skin to treat acne vulgaris. Along the same lines, a 4-week clinical study with extended release oral minocycline to assess the skin and plasma concentrations of minocycline was conducted. A marked reduction of mean acne lesion counts from baseline was seen with oral minocycline with presence in plasma. On the contrary no minocycline was identified in the skin from periauricular biopsies. Recently, BioPharmX completed a 4-week Phase 2 clinical repeat-dose study of BPX-01. The minocycline gel was well tolerated and over 90% of P. acnes were eliminated. A 12-week Phase 2 dose-finding clinical trial to further assess the efficacy and safety of BPX-01 for the treatment of moderate-to-severe, non-nodular inflammatory acne vulgaris has been initiated. The dose-finding study will provide additional support for the planned Phase 3 clinical trial program with BPX-01. (more…)
Author Interviews, Dermatology, Lifestyle & Health / 18.11.2016 Interview with: Luigi Naldi, MD Director Centro Studi GISED Department of Dermatology Azienda Ospedaliera papa Giovanni XXIII Bergamo Italy What is the background for this study? What are the main findings? Response: The study was the natural continuation of a previous case-control study focusing on risk factors for moderate to severe acne in adolescents. In that study, we documented the role of a westernized diet to influence acne severity, with a low weekly intake of fruits or vegetables, a low consumption of fresh fish and a high consumption of milk especially skim milk, being risk factors for moderate to severe acne. Not surprisingly, also a family history of acne was associated with acne severity. After completion of our study in adolescents, we realized that very little was known about acne in adults. Hence, we started a new case-control study focusing on risk factors for adult female acne. Besides the role of a family history, we documented that lifestyle factors could play an important role in adult acne. More specifically, being an office worker, and having a high level of reported psychological stress were associated with acne in adult women. In addition, similarly to acne in adolescents, low weekly intake of fruits or vegetables and a low consumption of fresh fish were documented as risk factors. It is important to find the reason for your acne. But it is also important to know that there is pretty much always a solution to dealing with this. It is understandable that many people find it hard to deal with, but it is something that you shouldn't let ruin your life. If you are someone who suffers with acne and are not sure on what the next steps are to help manage this effectively, it might be in your best interest to look into something like a cbd pure review from companies such as HerbMighty. You might be able to find the answers that you have been looking for when it comes to your acne. (more…)
Aging, Author Interviews, Dermatology / 05.10.2016 Interview with: Simone Ribero, M.D., Ph.D. University of Turin Department of Medical Sciences Turin. Italy & King’s College London Department of Twin Research and Genetic Epidemiology St Thomas’ campus London What is the background for this study? What are the main findings? Response: For many years dermatologists have identified that the skin of acne sufferers appears to age more slowly than in those who have not experienced any acne in their lifetime. We have demonstrated in our paper that there is an association between acne and longer telomere length that means that acne patients , with the same anagraphic age , have a younger chronological age. (more…)
Author Interviews, Dermatology, Pharmacology / 15.08.2016 Interview with: Kin F. Chan, PhD Executive Vice President of Research and Technology BioPharmX Corporation What is the background for this study? What are the main findings? Response: There were two studies in this series.  The purpose is to get a better understanding of the blood plasma and skin levels of minocycline in a relevant animal model (minipig) for both the oral form of minocycline (Solodyn) and topical BPX-01, and to elucidate the same for oral minocycline only in a clinical study. The results provided valuable guidance and assurance to our upcoming Clinical Phase 2b dose-ranging study design. (more…)
Author Interviews, Infections / 09.04.2016 Interview with: Dr Ramiz Boulos PhD School of Chemical and Physical Sciences Flinders University, Bedford Park Chief Executive Officer Boulos & Cooper Pharmaceuticals Pty Ltd Port Adelaide, SA, Australia What is the background for this study? What are the main findings? Dr. Boulos: Zolav® is a first generation antibiotic belonging to a novel class of small molecule synthetic antibiotics that was developed using in-silico modelling. It targets the mechanosensitive ion channel of large conductance, a highly conserved ion channel in bacteria not found in the human genome, making it a well sought after target. The channels have evolved to rescue bacteria from a high osmotic environment by acting as an emergency valve, opening up, and preventing bacteria from lysis. Our antibiotics reduce the threshold at which the channels open and elongate their opening times, in essence causing bacteria to "vomit". Acne affects about 650 million people worldwide making it one of the top ten most common diseases.  Isotretinoin, a vitamin A derivative, is currently the standard of care for treatment. However, it has a number of side effects among which a well-established teratogenic activity is the most serious, a reason for the development of novel and low-risk treatment options for acne. Zolav®,like other antibiotics in this new class, have low cytotoxicity, antioxidant properties and high chemical stability. The very low concentrations needed to yield a therapeutic effect and reduce inflammation in the mouse intradermal acne infection model, and the low risk nature of a topical administration of the drug, makes Zolav® a potentially very attractive option for the treatment of acne. (more…)
Author Interviews, Dermatology, Pharmacology / 22.12.2015 Interview with: Dr. Diana Lac, PhD Senior Scientist at BioPharmX Corporation. Dr. Lac received her PhD in Pharmacology and Toxicology from the University of California, Davis and currently focuses on the development of topical treatments for acne. MedicalResearch: What is the background for this study? What are the main findings? Dr. Lac: Acne affects almost 90% of people in western societies during their teenage years and may persist into adulthood. Currently, the oral tetracycline class of drugs dominates the acne treatment market. However, these treatments have been associated with a variety of adverse effects, such as headaches, dizziness, fatigue, nausea, photosensitivity, and severe itchiness. While a variety of acne treatments do exist, topical antibiotics particularly have had limited success due to formulation challenges. A topical minocycline formulation will provide a superior alternative for local treatment of acne, thereby limiting the amount of systemic exposure to the antibiotic and addressing the overall global antibiotic resistance problem. We believe that by directly delivering the drug to the skin we can decrease the amount of antibiotic exposure and also limit the off-target effects. We have developed a novel, stable minocycline gel formulation allowing for efficient delivery of minocycline directly to the pilosebaceous unit in the skin where Propionibacterium acnes typically reside. In this poster presentation we have demonstrated this effectively in live rats. A dose ranging study was conducted where drug delivery and safety of our novel formulation was assessed. A number of dose formulations were tested (up to 4% minocycline formulations) and were found to be non-irritating and safe for topical use. (more…)
Antibiotic Resistance, Author Interviews, Dermatology, NYU, Pharmacology / 30.10.2015 Interview with: Arielle Nagler MD Instructor, Department of Ronald O. Perelman Department of Dermatology NYU Langone Medical Center Medical Research: What is the background for this study of acne patient who eventually require isotretinoin? Dr. Nagler: Isotretinoin is a highly effective medication for the treatment of severe acne. In fact, it is the only medication that has been shown to provide patients with a durable cure for acne. However, its use is limited by its known teratogenicity as well as controversies regarding its relationship with psychiatric disturbances and inflammatory bowel disease. For many patients, systemic antibiotics provide an effective treatment for inflammatory acne. However, antibiotics do not provide the long term clearance that isotretinoin provides. Moreover, antibiotics are getting increasing attention due to fears of emerging bacterial resistance. There has been a recent emphasis on limiting antibiotic use in acne. As a result, this study sought to understand antibiotic use patterns amongst patients who eventually received isotretinoin.  (more…)
Author Interviews, Technology / 17.07.2015

Adam Friedman, MD, FAADAssociate Professor of Dermatology Residency Program Director Director of Translational Research Department of Dermatology George Washington School of Medicine and Health Interview with: Adam Friedman, MD, FAAD Associate Professor of Dermatology Residency Program Director Director of Translational Research Department of Dermatology George Washington School of Medicine and Health Sciences Medical Research: What is the background for this study? What are the main findings? Dr. Friedman: Acne vulgaris is one of the most  common skin disease that affects approximately 40-50 million people in the United States.    Acne’s multifactorial etiology, resulting from a mix of androgen-induced elevations in sebum production, abnormal follicular epithelial desquamation and proliferation, hypercolonization of Propionibacterium acnes and host inflammatory reactions, make treatment often times challenging. In looking at the topical therapeutic armament for Acne Vulgaris, which includes benzoyl peroxide, salicyclic acid, topical antibiotics such as clindamycin, and retinoids, all suffer from various related side effects including irritation, erythema, dryness, peeling and scaling, bacterial resistance, and resulting dyschromia from the associated irritation in patients of darker skin types. These adverse events often serve as major limiting factors influencing patient compliance and ultimately impacting efficacy. Therefore new treatments which target all of the complexities of acne are needed, especially given we have not had anything really new brought to market in years. Here, we looked to biology for the answer. Our bodies generate Nitric Oxide, a diatomic lipid loving gaseous molecule, to perform a broad range of biological activities, including but not limited to killing bacteria/fungi/viruses  and inhibiting inflammation - key elements in Acne. Its action however is very short lived and therefore using Nitric Oxide as a treatment is difficult as one would need a delivery system that would allow for continued and controlled release. Enter nanotechnology. We designed exceedingly small particles (of note, 1 nanometer = 1 billionth of a meter) which allow for the generation of nitric oxide gas from nitrite salt, and will only release the gas when exposed to moisture over time. The size of the particles also enables them to better interact with their environment, i.e. cells, pathogens, improving their activity as compared to large sized treatments In this study, we showed that the nitric oxide generating/releasing nano particles effectively killed the organism, P. acnes but was not toxic to both human skin cells and a live vertebrae model (embryonic zebra fish). More importantly, we found that the nano particles inhibits the activation of a newly recognized but exceedingly important inflammatory pathway that is directly tied to the formation of an acne lesion, called the NLRP3 inflammasome. Research has shown that our bodies already regulate this pathway with nitric oxide, and therefore once again, we are looking to biology for answers. As opposed to a drug that may only have one target, the nanoparticles inhibited multiple components/elements of the inflammasome pathway, giving some insight into its potential as a treatment for acne as well as other inflammatory diseases. (more…)
Author Interviews, Dermatology / 18.05.2015 Interview with:  Warren J. Winkelman, MD, MBA, PhD, FRCPC, FAAD Director, Medical Affairs Galderma Laboratories, L.P. Fort Worth TX 76177 MedicalResearch: What is the background for this study? What are the main findings? Dr. Winkelman: Rosacea is a common dermatologic facial disorder estimated to affect 16 million Americans. Rosacea is a chronic condition of the central face, including the nose, chin, cheeks and forehead, and is often characterized by flare-ups and remissions. While the cause of rosacea is unknown and there is no cure, its signs and symptoms can become markedly worse in the absence of treatment. Rosacea can be managed with topical and oral medications, and physicians often resort to using these medications in combination for more severe or resistant cases. Doxycycline 40 mg modified release (MR) and metronidazole 1% gel are FDA-approved oral and topical therapies, respectively, indicated to treat the papules and pustules of rosacea. We conducted a phase 2 study to assess the relapse rate, efficacy, and safety of doxycycline 40 mg MR compared to placebo after an initial 12-week once-daily combination regimen of doxycycline 40 mg MR and metronidazole 1% gel in subjects with moderate to severe disease. Of the 235 subjects enrolled in the study, 71% were women, 94% were white, and 75% had Fitzpatrick skin type I, II or III. The mean age was 47.4 years. The percentage of subjects who achieved a success score of 0 (clear) or 1 (near clear) improved from 0% at baseline to 51% at week 12. Clinician’s erythema assessment scores, inflammatory lesion counts, and quality of life scores also improved. Most subjects reported no or mild scaling, stinging/burning, and dryness. Five adverse events were reported that were considered probably or definitely related to treatment: fungal infection, vulvovaginal mycotic infection, pain in extremity, erythema, and skin exfoliation. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, JAMA / 22.03.2015

Dr. Arash Mostaghimi, MD, MPA Director of Dermatology Inpatient Service Brigham and Women’s Hospital Boston, Interview with: Dr. Arash Mostaghimi, MD, MPA Director of Dermatology Inpatient Service Brigham and Women’s Hospital Boston, MA     Medical Research: What is the background for this study? What are the main findings? Dr. Mostaghimi: Spironolactone, a generic drug that’s been used in the clinic since 1959, is commonly prescribed for treating hormonal acne – acne that tends to affect the jaw line most commonly around the time of the month when a woman gets her period. The US Food and Drug Administration recommends frequent potassium monitoring in patients with heart failure who are taking spironolactone as a diuretic and antihypertensive treatment, but it’s been unclear if these guidelines should apply to healthy patients taking spironolactone for the treatment of acne, and, if so, how frequently such patients should have their potassium levels tested. My colleagues and I have found that for young, healthy women taking spironolactone to treat hormonal acne, potassium monitoring is an unnecessary health care expense. For the approximately 1,000 patients we studied, blood tests to monitor potassium levels did not change the course of treatment, but the tests cumulatively totaled up to $80,000. We suggest that routine potassium monitoring should no longer be recommended for this patient population in order to improve the patient care experience, decrease unnecessary office visits and reduce health care spending. (more…)
Author Interviews, Dermatology, Gastrointestinal Disease, JAMA, Mayo Clinic / 11.09.2014

Shadi Rashtak, MD Department of Dermatology Mayo Clinic College of Medicine Rochester, Interview with: Shadi Rashtak, MD Department of Dermatology Mayo Clinic College of Medicine Rochester, Minnesota Medical Research:  What are the main findings of the study? Dr. Rashtak: We found that among a population of mainly acne patients those who received isotretinoin had a lower risk of inflammatory bowel disease as compared to those who did not take this medication. We carefully reviewed the medical records of patients to ensure that this finding was not simply because the drug was avoided in patients with a previous personal or family history of IBD. (more…)