Dermatological Drugs Research Articles

Association Between Market Competition and Prices of Generic Topical Dermatology Drugs

During the last decade, increases in drug prices for commonly prescribed dermatologic medications have outpaced the rate of inflation, national health care growth, and reimbursements. Among nondermatologic medications, studies have shown a role for robust generic market competition in reducing drug prices. The association between competition and the costs of topical dermatologic generic drugs has not been evaluated. To characterize the association between changes in drug price and the number of US Food and Drug Administration (FDA)-approved manufacturers among the most commonly used topical dermatologic generic products. This retrospective cost analysis of the most commonly prescribed topical dermatologic generic drugs used cumulative annual claims data from the Medicare Part D Prescriber Public User File to identify 597 dermatologist-prescribed drugs with more than 10 claims. The number of manufacturers and the price per unit were identified from the FDA Orange Book and the National Average Drug Acquisition Cost (NADAC) database, respectively, for 2013 through 2016. Drugs that were nondermatologic, were not topically administered, were missing NADAC data, were lacking a generic formulation, or had fewer than 400 claims were excluded. Primary outcomes included per-unit drug price and number of FDA-approved manufacturers. Pricing measures were adjusted for inflation and are reported in 2016 dollars. The present analysis included 116 topical dermatologic generic formulations, representing 70.5% of the total Medicare Part D dermatologist-coded claims from 2015. Drug formulations with 1 to 2 manufacturers during the study period sustained a median percentage increase in price of 12.7%, whereas those with more than 6 manufacturers had a median percentage decrease in price of 20.5%. Formulations with 1 to 2 manufacturers had a 20.6%, 19.5%, and 33.2% higher percentage increase in price than those with 3 to 4 manufacturers, 5 to 6 manufacturers, and more than 6 manufacturers, respectively. There was a statistically significant inverse association between the percentage change in drug price and median number of manufacturers (Spearman correlation coefficient, -0.26; P = .005). The negative association between the change in drug price and the median number of manufacturers of generic topical dermatologic drugs indicates a role for market competition in controlling the costs of generic drug prices within dermatology. These findings support policies that facilitate robust market competition among topical dermatologic generic drugs produced by a limited number of manufacturers.

Involvement of the central hypothalamic-pituitary-adrenal axis in hair growth and melanogenesis among different mouse strains.

Stress has been demonstrated to play an important role in hair follicle function and the pathogenesis of some hair disorders. The central hypothalamic-pituitary-adrenal (HPA) axis is activated by stress stimuli, synthesizes and releases various components and eventually induces the pathogenesis and recurrence of peripheral diseases. Our aim is to compare the different responses under exposure of stress in hair follicle function among different mouse strains, and to detect the involvement of the central HPA axis after stress in hair follicle growth and melanogenesis. In this study, we exposed different mouse strains (C57BL/6, CBA/J, C3H/HeN, BALB/c and ICR) to a 21-day chronic restraint stress protocol and selected C57BL/6, CBA/J and BALB/c mice for further study because of their significant behavioral alterations. Then, we evaluated and compared the different responses and sensitivity to chronic restraint stress in hair follicle function and central HPA axis among the selected strains. The results showed that expression of POMC, CRF and GR mRNA and protein and serum levels of corticosterone were inhibited in response to stress. These findings suggested that chronic restraint stress may inhibit hair follicle growth and melanogenesis via regulating the key elements of the central HPA axis. In addition, the results revealed different mouse strains exhibit different responses in the central HPA axis and hair follicle after stress exposure. C57BL/6 might be the most sensitive strain among the three strains tested as well as an appropriate strain to study possible pathophysiological mechanisms by which the nervous system influences skin function and screen dermatological drugs suitable for psychotherapy. We believe the current study will provide some useful information for researchers who are interested in the bidirectional communication between the nervous and skin systems and the management of stress-induced cutaneous diseases.

Use of antipsychotic drugs in dermatology

Antipsychotic drugs can be beneficial in dermatology because of their both central nervous system and peripheral effects. All antipsychotic drugs have a central postsynaptic dopamine D2 receptor blocking effect, which underlies their antipsychotic action. The antipsychotic drugs have varying degrees of histamine H1-receptor, cholinergic muscarinic receptor, and α1-adrenergic receptor blocking effects, which can affect cutaneous perception and the autonomic reactivity of the skin and can be potentially beneficial in the management of certain histamine or sympathetically mediated dermatologic manifestations (eg, urticaria, pruritus, hyperhidrosis). In addition to their antipsychotic effect, antipsychotic drugs also have a general anxiolytic effect related in part to their α1-adrenergic receptor blocking action, which can be of benefit in many dermatologic conditions, including pruritus. The antipsychotic drugs are most commonly used in dermatology for the management of a delusional disorder, somatic type, manifesting as delusional infestation, and as monotherapy or as augmentation therapy of selective serotonin reuptake inhibitor (SSRI) antidepressants, and for management of trichotillomania and skin-picking or excoriation disorder. There is earlier literature (1) on the possible beneficial effect of the phenothiazine antipsychotics in a wide range of pruritic dermatoses, and (2) the efficacy of pimozide as adjunctive therapy for metastatic melanoma, which both warrant further investigation.

A systematic literature review of the human skin microbiome as biomarker for dermatological drug development.

AimsTo explore the potential of the skin microbiome as biomarker in six dermatological conditions: atopic dermatitis (AD), acne vulgaris (AV), psoriasis vulgaris (PV), hidradenitis suppurativa (HS), seborrhoeic dermatitis/pityriasis capitis (SD/PC) and ulcus cruris (UC).MethodsA systematic literature review was conducted according to the PRISMA guidelines. Two investigators independently reviewed the included studies and ranked the suitability microbiome implementation for early phase clinical studies in an adapted GRADE method.ResultsIn total, 841 papers were identified and after screening of titles and abstracts for eligibility we identified 42 manuscripts that could be included in the review. Eleven studies were included for AD, five for AV, 10 for PV, two for HS, four for SD and 10 for UC. For AD and AV, multiple studies report the relationship between the skin microbiome, disease severity and clinical response to treatment. This is currently lacking for the remaining conditions.ConclusionFor two indications – AD and AV – there is preliminary evidence to support implementation of the skin microbiome as biomarkers in early phase clinical trials. For PV, UC, SD and HS there is insufficient evidence from the literature. More microbiome‐directed prospective studies studying the effect of current treatments on the microbiome with special attention for patient meta‐data, sampling methods and analysis methods are needed to draw more substantial conclusions.

Description of Patients Treated with Biologic Drugs as First-Line Systemic Therapy in the BIOBADADERM Registry Between 2008 and 2016

Introduction and objectivesBiologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. Material and methodWe conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. ResultsThe characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. ConclusionsNo major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.

Clinical Outcomes of Drug-related Problems in Saudi Arabia: Patients’ and Healthcare Providers’ Perspective

<p style="text-align: justify;"><strong>Purpose:</strong> To explore the patients and healthcare providers&rsquo; attitudes and perceptions on clinical outcomes drug-related problems in Saudi Arabia. <strong>Methods:</strong> It is a 4-months cross-sectional survey of drug-related problem information in Saudi Arabia. The study consisted of two-part a demographic data. The second part contained the questions about the frequent occurrence of drug-related problems, the type of medication-induced those problems, and the drug-related problem clinical consequences and outcomes. American Society of Health- System Pharmacist definitions of drug-related problems used. The 5-point Likert response scale system used. The survey distributed through social media. The questionnaire made of an electronic format, and it analyzed through survey monkey system. <strong>Results:</strong> The total responders were two hundred and one; the Saudi nationality was 188 (93.5%), and non-Saudi was 13 (6.5%) patient. The gender distribution was female 180 (89.6%), and the male was 21 (10.4%). The majority of them in age (18-44) 88% and located in Riyadh region 84 (41.8%) and Asir region 59 (29.4%). Of those 44 (22.1 %) were healthcare providers. The responders showed a high percentage of drug-related problem consequences and outcomes; drug-related problem lead to pharmacy visit was 59 (29.5%), additional tests were 47 (24.35%), ambulatory care clinic visit was 76 (38.4%), and an emergency visit was 43 (21.4%). The hospital admission was 46 (23.1%), general surgery 24 (11.9%), critical care admission was 24 (12.1%), and drug-induced death was 48 (24.12%). The most frequent drug-related problems occurred with the patient last year at least once; it was drug noncompliance 142 (71.4%), indications without medication 100 (50%), and adverse medication events 80 (40%). The most type of medicines induced the problems were Antibiotics, the drugs for pain, and dermatology drugs. <strong>Conclusion:</strong> Clinical outcome of drug-related problems occurred was potential. Clinical pharmacy services with emphasis to a drug-related program of antibiotics, painkiller dermatology medications are necessary. Moreover, to patient counseling program in health institutions and public awareness of medications is required in Saudi Arabia. <p style="text-align: justify;"><strong>Key words:</strong> Clinical outcomes, Drug-related problems, Patients, Healthcare providers, Perspective, Saudi Arabia.

Descripción de los pacientes que reciben biológicos como primer tratamiento sistémico en el registro BIOBADADERM durante el periodo 2008-2016

Introduction and objectivesBiologic drugs are usually prescribed as second-line treatment for psoriasis, that is, after the patient has first been treated with a conventional psoriasis drug. There are, however, cases where, depending on the characteristics of the patient or the judgement of the physician, biologics may be chosen as first-line therapy. No studies to date have analyzed the demographics or clinical characteristics of patients in this setting or the safety profile of the agents used. The main aim of this study was to characterize these aspects of first-line biologic therapy and compare them to those observed for patients receiving biologics as second-line therapy. Material and methodWe conducted an observational study of 181 patients treated in various centers with a systemic biologic drug as first-line treatment for moderate to severe psoriasis between January 2008 and November 2016. All the patients were registered in the Spanish Registry of Adverse Events Associated with Biologic Drugs in Dermatology. ResultsThe characteristics of the first- and second-line groups were very similar, although the patients receiving a biologic as first-line treatment for their psoriasis were older. No differences were observed for disease severity (assessed using the PASI) or time to diagnosis. Hypertension, diabetes, and liver disease were all more common in the first-line group. There were no differences between the groups in terms of reasons for drug withdrawal or occurrence of adverse effects. ConclusionsNo major differences were found between patients with psoriasis receiving biologic drugs as first- or second-line therapy, a finding that provides further evidence of the safety of biologic therapy in patients with psoriasis.

Flutamide-Loaded Zein Nanocapsule Hydrogel, a Promising Dermal Delivery System for Pilosebaceous Unit Disorders.

Zein is a naturally occurring corn protein having similarity to skin keratin. Owing to its hydrophobicity and biodegradability, zein nanocarriers are promising drug delivery vehicles for hydrophobic dermatological drugs. In this study, zein-based nanocapsules (ZNCs) were exploited for the first time as dermal delivery carriers for flutamide (FLT), an antiandrogen used for the management of pilosebasceous unit disorders. FLT-loaded ZNC of appropriate particle size and negative surface charge were prepared by nanoprecipitation method. The dermal permeation and skin retention of FLT from ZNCs were studied in comparison to corresponding nanoemulsion (NE) and hydroalcoholic drug solution (HA). ZNCs showed a significantly lower permeation flux compared to NE and HA while increasing the skin retention of FLT. Confocal laser scanning microscopy (CLSM) demonstrated the follicular localization of the fluorescently labeled NCs. The incorporation of NCs in chitosan gel or Carbomer® 934 gel was studied. Carbomer® gel increased the skin retention of FLT compared to chitosan gel. Accordingly, Carbomer® hydrogel embedding FLT-loaded ZNCs is a promising inexpensive, biocompatible dermal delivery nanocarrier for localized therapy of PSU disorders suitable for application on oily skin.

Brimonidine

ABSTRACT A drug is a particular substance in physiology that exerts an effect when ingested or otherwise introduced into the body. Drugs may be administered in a variety of constitutions from capsules, injections, creams, and ointments to inhalants, liquids, and dermal patches; via different routes, namely, topical, parenteral, and inhalation; and via injection routes such as subcutaneous, intramuscular, or intravenous. The purpose of this column is to highlight some of the more commonly encountered drugs in dermatology. More specifically, this column will bring further understanding to the mechanism of action, administration, dosage, adverse effects, and viable alternatives to each particular drug being discussed. In this article, the role of the drug brimonidine tartrate, as a dermatologic treatment for erythema associated with rosacea, will be discussed.

Inhibition by non-steroidal anti-inflammatory drugs of compound action potentials in frog sciatic nerve fibers

AimsAlthough antinociception produced by non-steroidal anti-inflammatory drugs (NSAIDs) is partly attributed to nerve conduction inhibition, this has not been thoroughly examined yet. The aim of the present study was to reveal quantitatively how various types of NSAIDs affect compound action potentials (CAPs), a measure of nerve conduction. Main methodsCAPs were recorded from the frog sciatic nerve by using the air-gap method. Key findingsSoaking the sciatic nerve with acetic acid-based NSAIDs (diclofenac and aceclofenac) reduced the peak amplitude of CAP in a concentration-dependent manner; their IC50 values were 0.94 and 0.47 mM, respectively. Other acetic acid-based NSAIDs (indomethacin, acemetacin and etodolac) also inhibited CAPs [the extent of inhibition: some 40% (1 mM), 40% (0.5 mM) and 15% (1 mM), respectively], except for sulindac and felbinac at 1 mM that had no effects on CAP peak amplitudes. A similar inhibition was produced by fenamic acid-based NSAIDs [tolfenamic acid (IC50 = 0.29 mM), meclofenamic acid (0.19 mM), flufenamic acid (0.22 mM) and mefenamic acid] which are similar in chemical structure to diclofenac and aceclofenac; their derivatives (2,6-dichlorodiphenylamine and N-phenylanthranilic acid) also inhibited. On the other hand, salicylic acid-based (aspirin), propionic acid-based (ketoprofen, naproxen, ibuprofen, loxoprofen and flurbiprofen) and enolic acid-based (meloxicam and piroxicam) NSAIDs had no effects on CAP peak amplitudes. SignificanceAt least a part of antinociception produced by NSAIDs used as a dermatological drug to alleviate pain may be attributed to their inhibitory effects on nerve conduction, which depend on the chemical structures of NSAIDs.

Catalyzing Future Drug, Device, and Information Technology Breakthroughs in Dermatology

Catalyzing Future Drug, Device, and Information Technology Breakthroughs in Dermatology

Does €1 Per Prescription Make a Difference? Impact of a Capped Low-Intensity Pharmaceutical Co-Payment.

Increasing patient contributions and reducing the population exempt from pharmaceutical co-payment and co-insurance rates were one of the most common measures in the reforms adopted in Europe during 2010-2015. We estimated the association between the introduction of a capped co-payment of €1 per prescription and drug consumption of the publicly insured population of Catalonia (Spain). We used administrative data on monthly pharmaceutical consumption (defined daily doses [DDDs]) from January 2012 to December 2014, for a representative sample of 85,000 people. Our results showed that consumption increased in the 2months previous to the introduction of the measure, and fell with the introduction of the 'Euro per prescription' co-payment. The average net response associated with the reform (including anticipation) was a reduction of 4.1 DDDs per person per month, representing a 6.4% reduction. The decrease in pharmaceutical consumption was larger for those individuals who had free medicines prior to the reform compared with those who already paid a co-insurance rate (9.7 vs. 1.4 DDDs per person per month). The largest reduction in DDDs per person occurred in the following groups: dermatologic drugs, antihypertensives, non-insulin antidiabetic drugs, insulin antidiabetic drugs, and laxatives. A uniform capped low co-payment may give rise to a major reduction in drug consumption to a much greater extent among those who previously had free prescriptions.

Caffeine: traditional and new therapeutic indications and use as a dermatological model drug

Coffee consumption had already been described in the 15th century. The spreading of coffee drinking was not only a consequence of its delicious aromatic taste, but also of its pharmacological effects, especially due to its caffeine content. In this review, the mechanisms behind its complex stimulatory effects and the latest studies on the possible new therapeutic indications of caffeine are summarized. Several papers reported the neuroprotective (in Alzheimer's and Parkinson's disease) and hepatoprotective profiles of caffeine, and we show the most promising new results about its preventive properties in dermal malignancies. These findings were described both in cell cultures and in vivo. The application of caffeine and coffee in cosmetology and dermatological products is based on their antioxidant property and on the above-mentioned beneficial effects. Caffeine is also presented here as a dermatological model drug due to its hydrophilic profile. It can be used for designing and comparing different novel drug formulations, although beside the transcellular route, the follicular and transappendageal pathways play also important roles in its skin penetration. Taken together, caffeine molecule has many recently discovered beneficial pharmacological effects, but one should be careful with its excessive consumption. It can result in several adverse events if overdosed and in case of regular intake of high doses, after abandonment, withdrawal symptoms may appear. Orv Hetil. 2018; 159(10): 384-390.

Human papillomavirus and immunosuppressive drugs in dermatology - a 'neoplastic' combination?

Human papillomavirus and immunosuppressive drugs in dermatology - a 'neoplastic' combination?

Food and drug administration approval process for dermatology drugs in the United States

Aim: The purpose of this review is to elucidate the steps involved in the FDA’s approval of new dermatology drugs.Methods: To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).Results: In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three phases of clinical trials in humans before undergoing review by the Food and Drug Administration (FDA). This review process involves an interdisciplinary team of scientists that determines if the drug should be brought to market based on its efficacy, risk-to-benefit ratio, and ability to be labeled. The team that specifically reviews dermatology drugs within the Center for Drug Evaluation and Research (CDER) at the FDA is the Division of Dermatologic and Dental Drug Products.Conclusions: The drug development process is enhanced by clinician input during all stages of development.

Safety of important dermatological drugs (retinoids, immune suppressants, anti androgens and thalidomide) in reproductively active males with respect to pregnancy outcome: A brief review of literature.

Paternally transmitted damage to offspring is recognized as a complex issue. Each parent contributes 23 chromosomes to a child; hence, it is necessary to know the effects of both maternal and paternal pre-and peri-conceptional exposure to drugs on pregnancy outcome. While there are many studies on the effects of maternal drug exposure on pregnancy outcome, literature on paternal exposure is scarce. Of late however, paternal exposure has been receiving increasing attention. We present a brief review on the safety of commonly used drugs in dermatology, focused on retinoids, immune suppressants, anti androgens and thalidomide.

Anti-wrinkle Effects of Mixed Extracts of Three Medicinal Herbs

Background/Objectives: The utilization of cosmetic raw materials for medicinal purposes in oriental medicine has been increasing on the basis of their eco-friendly image. Methods/Statistical analysis: The anti-wrinkle effects of the extract were assessed on the eye rims. The extract was always applied under the same experimental conditions in a clean and dry state after the patients rested in an air-conditioned room for at least 30 min (22±2?, R.H. 40~60%). A cutometer (MPA 580, Courage and Khazaka Electronic Co., Germany) was used to measure wrinkle improvements. Findings: The clinical assessment was approved by the Institutional Review Board (IRB). The results of the clinical assessment performed on 22 participants showed an increase in skin elasticity by 12.7% and 11.1% at 2 weeks and 4 weeks after the test initiation, respectively. This result demonstrates that the 3 medicinal herbs can reduce wrinkles caused by aging and may be used as raw materials in the development of cosmetic products. The medicinal herbs caused no irritation in the skin irritation test, and thus, they were clinically proved safe. Through this research, we were able to confirm the safety of medicinal herbs and understand the principles of oriental medicine. The findings of this study may promote the utilization of medicinal herbs in relevant industries. They also suggest the potential of the 3 medicinal herbs, Coptischinensis,Cimicifugaheracleifolia,and Poriacocos (Schw) as raw materials for the development of cosmetic products and topical dermatologic drugs. Improvements/Applications: The results suggested that an individual medicine, as well as a combination of various medicines, based on the theories of traditional oriental medicine, have certain effects on skin health.

Research of dermatological medicines assortment for treatment of infectious skin diseases

Today, the pharmaceutical market offers consumers a wide range of antimicrobial dermatological products for local use. Skin infectious diseases make up a significant part of human infectious pathologies.Aim. The purpose of scientific research is to analyze the range of dermatological drugs for the treatment of infectious diseases of the skin, including acne, as well as dermatoses, according to various criteria, to investigate the state of the domestic pharmaceutical market for the treatment of acne, to analyze the contingent of patients using these means for the treatment of skin diseases.Materials and methods. Empirical, experimental and theoretical methods, analysis of data of professional scientific publications and other literary sources, marketing analysis, classification, generalization, analysis of statistical data.Results. A commodity assortment of dermatological agents for the treatment of infectious diseases, in particular acne, as well as dermatoses, has been studied. The product range of dermatological agents for the treatment of infectious diseases of the skin, including acne, as well as dermatoses, was studied. The problem of antibiotic resistance of pathogenic microorganisms is considered.Conclusions. The results of our studies indicate the relevance of the development of a new dermatological agent in the form of gel based on fusidic acid for the treatment of acne.

Drugs in Dermatology

ABSTRACT A drug is a substance used to cause a physiological change in the human body. In dermatology, drugs that treat different disorders usually fall into three categories: oral, topical, and biologic medications. Topical drugs include antibacterial and antifungal creams, corticosteroids, and gels. This column will explore the mechanism of action of Ameluz as well as its efficacy, dosage, administration, adverse effects, and alternatives.

Drugs in Dermatology

ABSTRACT By definition, a drug is a medicine or substance that exerts a physiologic effect on an organism. In dermatology, various medications and substances are utilized on a daily basis, ranging from topical treatments to anesthetics in micrographic surgery. The purpose of this section is to focus on some of the more common substances, specifically how they work, how they are utilized, and routine alternatives (if available). The mechanism of action, usage, and alternative options of the combination Kligman’s solution (triple combination cream of tretinoin, hydroquinone, and topical corticosteroid) are discussed.