Rx -to- OTC switch increased access and lowered cost of topical adapalene.

Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition. We demonstrate that the prescription to OTC transition of adapalene gel increased access to this medication, while lowering costs to patients and payers, including Medicare patients. These results provide a necessary call to action for future OTC shifts with other high safety profile, well-tolerated medications in ultimate efforts and hopes of cost savings for patients, insurers, and Medicare within our healthcare industry.

Barriers and Facilitators Affecting Long-Term Antibiotic Prescriptions for Acne Treatment.

Importance: Dermatologists prescribe more oral antibiotics per clinician than clinicians in any other specialty. Despite clinical guidelines that recommend limitation of long-term oral antibiotic treatments for acne to less than 3 months, there is little evidence to guide the design and implementation of an antibiotic stewardship program in clinical practice. Objective: To identify salient barriers and facilitators to long-term antibiotic prescriptions for acne treatment. Design, Setting, and Participants: This qualitative study assessed data collected from stakeholders (including dermatologists, infectious disease physicians, dermatology resident physicians, and nonphysician clinicians) via an online survey and semistructured video interviews between March and August 2021. Data analyses were performed from August 12, 2021, to January 20, 2024. Main Outcomes and Measures: Online survey and qualitative video interviews developed with the Theoretical Domains Framework. Thematic analyses were used to identify salient themes on barriers and facilitators to long-term antibiotic prescriptions for acne treatment. Results: Among 30 participants (14 [47%] males and 16 [53%] females) who completed the study requirements and were included in the analysis, knowledge of antibiotic guideline recommendations was high and antibiotic stewardship was believed to be a professional responsibility. Five salient themes were to be affecting long-term antibiotic prescriptions: perceived lack of evidence to justify change in dermatologic practice, difficulty navigating patient demands and satisfaction, discomfort with discussing contraception, iPLEDGE-related barriers, and the absence of an effective system to measure progress on antibiotic stewardship. Conclusions and Relevance: The findings of this qualitative study indicate that multiple salient factors affect long-term antibiotic prescribing practices for acne treatment. These factors should be considered in the design and implementation of any future outpatient antibiotic stewardship program for clinical dermatology.

Development of solid lipid microparticles (SLMs) containing asiatic acid for topical treatment of acne: Characterization, stability, in vitro and in vivo anti-acne assessment.

Solid lipid microparticles (SLMs) represent a promising approach for drug delivery in anti-acne applications. In this study, asiatic acid-loaded SLMs (AASLMs) were prepared by melt emulsification method in conjunction with freeze-drying. Comprehensive evaluations comprised particle size, %entrapment efficiency (%EE), %labeled amount (%LA), surface morphology, stability, %release, %skin permeation, and anti-acne activity. The AASLMs exhibited an average particle size ranging from 7.46 to 38.86 µm, with %EE and %LA falling within the range of 31.56 to 100.00 and 90.43 to 95.38, respectively. The AASLMs demonstrated a spherical shape under scanning electron microscopy, and maintained stability over a 3-month period. Notably, formulations with 10 % and 15 % cetyl alcohol stabilized with poloxamer-188 (specifically F6 and F12) displayed a minimum inhibitory concentration (MIC) value of 75 mg/ml against Cutibacterium acnes. Furthermore, F12 exhibited a higher %release and %skin permeation compared to F6 over 24 h. In a single-blind clinical trial involving fifteen participants with mild-to-moderate acne, F12 showcased its potential not only in reducing porphyrin intensity and enhancing skin barriers but also in significantly improving skin hydration and brightness. However, further investigations with larger subject cohorts encompassing diverse age groups and genders are necessary to thoroughly establish the performance of the developed AASLMs.

Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial.

OBJECTIVE: This study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks. DESIGN: Economic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial. SETTING: Primary and secondary healthcare, community and social media advertising. PARTICIPANTS: Women ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment. INTERVENTIONS: Participants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment. MAIN OUTCOME MEASURES: Cost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments). RESULTS: Spironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis). CONCLUSIONS: The results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis. TRIAL REGISTRATION NUMBER: ISRCTN registry (ISRCTN12892056).

Optimization, characterization, and follicular targeting assessment of tretinoin and bicalutamide loaded niosomes.

Acne vulgaris, a prevalent skin disorder among teenagers and young adults, can have numerous psychological consequences. Topical treatment of acne would be advantageous by reducing the risk of systemic adverse drug reactions. However, the major challenge would be skin penetration through the stratum corneum. Therefore, during this study, tretinoin (TRT) and bicalutamide (BCT) loaded niosomes with follicular targeting potential were fabricated through the thin film hydration technique. Formulation optimization was performed using the Design-Expert software and optimum formulation was characterized in terms of particle size, zeta potential, transmission electron microscopy, drug loading, and differential scanning calorimetry. In vivo follicular targeting was assessed using rhodamine B-loaded niosomes to follow the skin penetration pathways. The results showed that, the optimum formulation was spherical in shape and had an average diameter of 319.20 ± 18.50 nm and a zeta potential of - 29.70 ± 0.36 mV. Furthermore, entrapment efficiencies were 94.63 ± 0.50% and > 99% and loading capacities were 1.40 ± 0.01% and 1.48 ± 0.00% for BCT and TRT, respectively. According to the animal study results, the prepared niosomes with an average diameter of about 300 nm showed significant accumulation in hair follicles. It seems that the designed niosomal BCT-TRT co-delivery system would be promising in acne management with follicular targeting potential.

From Breakouts to Bargains: Strategies for Patient-Centered, Cost-effective Acne Care.

A range of treatment options are available for both mild to moderate and moderate to severe acne, and these options vary widely in their clinical uses, effectiveness, and costs. With the continued rise of dermatologic drug prices and increased cost-sharing due to high-deductible health plans, the importance of cost-effective treatment continues to grow. Failure to consider cost-effective, patient-centered care may lead to increased financial toxicity, reduced adherence, and ultimately worse outcomes and patient satisfaction. Combination topical products offer improved efficacy and convenience, which are associated with better adherence and outcomes. Generic fixed-dose adapalene-benzoyl peroxide (BPO) and fixed-dose clindamycin-BPO can be highly cost-effective options for patients with mild to moderate acne. Hormonal agents such as combined oral contraceptives (COCs) and spironolactone are inexpensive and likely reflect a highly cost-effective option that could reduce reliance on oral antibiotics in patients with moderate to severe acne. Doxycycline and isotretinoin also are cost-effective options for more severe acne. Frequent laboratory monitoring for spironolactone and isotretinoin continues to be prevalent despite little evidence to support its clinical utility, and it is associated with a major cost burden to the patient and health care system. The reduction of laboratory monitoring is an opportunity to provide higher-value care.

Evaluation of the efficacy of maintenance therapy for acne vulgaris using adapalene 0.1%/benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel for 24 weeks and assessment of atrophic acne scars using three-dimensional image analysis.

Maintenance therapy after remission of inflammation is strongly recommended in the guideline for the treatment of acne vulgaris published by the Japanese Dermatological Association. One advantage of continuing maintenance therapy is the alleviation of atrophic scarring. This study investigated the efficacy of maintenance therapy using adapalene 0.1%/benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel, and its effects on atrophic scarring. Overall, 126 patients were randomized to the adapalene/benzoyl peroxide group (n = 40), benzoyl peroxide group (n = 44), and control group (without maintenance treatment drugs; n = 42), and 111 of these completed a trial lasting 24 weeks. As the primary endpoint, the treatment success rate (the percentage of patients in whom the number of inflammatory lesions was maintained at ≤10) was 89.2% in the adapalene/benzoyl peroxide group, 87.5% in the benzoyl peroxide group, and 47.4% in the control group. Compared with the control group, the success rates were significantly higher in the adapalene/benzoyl peroxide and benzoyl peroxide groups (P = 0.0006 for both). As one of the secondary endpoints, the rate of change in the number of atrophic scars showed significant improvement from the baseline in the adapalene/benzoyl peroxide and benzoyl peroxide groups at week 24 (P = 0.0004 and P < 0.0001, respectively). Although the three-dimensional image analysis parameters did not change significantly from the baseline in the adapalene/benzoyl peroxide and benzoyl peroxide groups at week 24, significant worsening was noted in the control group (P = 0.0276 for affected area, P = 0.0445 for volume, and P = 0.0182 for maximum depth). Adverse drug reactions were noted in three patients in the adapalene/benzoyl peroxide group (7.5%) but not in the benzoyl peroxide group. These findings suggest that maintenance therapy using adapalene 0.1%/benzoyl peroxide 2.5% gel and benzoyl peroxide 2.5% gel is effective in preventing the worsening of scars in Japanese patients with acne vulgaris.

Characterization of a live Cutibacterium acnes subspecies defendens strain XYCM42 and clinical assessment as a topical regimen for general skin health and cosmesis.

BACKGROUND: When formulating topical products to treat skin diseases and addressing general skin health and cosmesis, most of the focus has traditionally been placed on how any given ingredient may impact the structure, function, and health of human skin elements. However, recent research is beginning to highlight the importance of the skin microbiome in relation to certain skin conditions and general cosmesis. Cutibacterium acnes is one of the most prolific skin-specific bacterial species. Research has shown that the species is divided into subspecies, some of which are thought to be beneficial to the skin. This paper aims to determine the efficacy of strainXYCM42, a C. acnes subspecies defendens derived strain designed to improve the health and appearance of the skin. METHODS: In vitro studies were performed on human keratinocyte and fibroblast monolayers, human peripheral blood mononuclear cells (PBMC), and skin explants to elucidate the effects of live XYCM42 cells and their ferment on human skin cells and tissues. Subsequently, clinical studies were performed using XYCM42-based topical regimens designed to deliver and support the engraftment of live XYCM42 cells onto subjects' skin. Two studies were performed, a 3-week pilot study (n = 10) and a 8-week pivotal study (n = 121). In the latter, 32 subjects were enrolled for an in-clinic portion for efficacy evaluation, with clinic visits occurring at Baseline, Week 1, Week 4, and Week 8. RESULTS: In vitro data suggest that XYCM42 and its ferment filtrate have potential to provide benefits to the skin via antioxidant, anti-inflammatory, and select antimicrobial activities. Clinical observation demonstrated that a XYCM42-containing regimen supports a healthy skin environment, promotes increased skin hydration, decreases erythema, calms the skin, and regulates sebum production. CONCLUSION: These studies provide further evidence that specific strains of C. acnes, such as XYCM42, have a more beneficial function regarding skin health and appearance than was previously thought. Appropriate use of formulations derived from symbiotic strains within the skin microbiome can support the development of novel, beneficial topicals.

Patient Preferences for Acne Vulgaris Treatment and Barriers to Care: A Survey Study.

The associated direct and indirect costs of acquiring acne vulgaris (acne) treatment from a clinician may prohibit some patients from doing so. Barriers to care may also influence patient preferences for treatment, and while both over-the-counter (OTC) and prescription acne treatments are efficacious, preferences for OTC or prescription acne medications are not well established. We recruited 529 adult subjects from the United States through Amazon Mechanical Turk (MTurk), and subjects were surveyed about acne, their acne treatment preferences, and any barriers to care. A total of 450 subjects passed the attention check and were included in the analysis. Of respondents who had tried both OTC and prescription treatments (n=223), more respondents reported that they preferred prescription treatments (130/223, 58.3%), compared with OTC treatments (64/223, 28.7%); or no preference (29/223, 13.0%; P=0.00001). Almost half of all respondents also stated that they experienced barriers to accessing medical care for acne treatment (192/450 42.7%); cost and transportation were the top 2 factors. Considering how common barriers are, and their everchanging nature, some patients may benefit from a discussion of alternative non-prescription acne treatments, serving as a bridge to therapy or while patients are unable to reach a medical provider. J Drugs Dermatol. 2022;21(11):1191-1195. doi:10.36849/JDD.6940.

Cost-effectiveness of topical pharmacological, oral pharmacological, physical and combined treatments for acne vulgaris.

BACKGROUND: Acne vulgaris is a common skin condition that may cause psychosocial distress. There is evidence that topical treatment combinations, chemical peels and photochemical therapy (combined blue/red light) are effective for mild-to-moderate acne, while topical treatment combinations, oral antibiotics combined with topical treatments, oral isotretinoin and photodynamic therapy are most effective for moderate-to-severe acne. Effective treatments have varying costs. The National Institute for Health and Care Excellence (NICE) in England considers cost-effectiveness when producing national clinical, public health and social care guidance. AIM: To assess the cost-effectiveness of treatments for mild-to-moderate and moderate-to-severe acne to inform relevant NICE guidance. METHODS: A decision-analytical model compared costs and quality-adjusted life-years (QALYs) of effective topical pharmacological, oral pharmacological, physical and combined treatments for mild-to-moderate and moderate-to-severe acne, from the perspective of the National Health Service in England. Effectiveness data were derived from a network meta-analysis. Other model input parameters were based on published sources, supplemented by expert opinion. RESULTS: All of the assessed treatments were more cost-effective than treatment with placebo (general practitioner visits without active treatment). For mild-to-moderate acne, topical treatment combinations and photochemical therapy (combined blue/red light) were most cost-effective. For moderate-to-severe acne, topical treatment combinations, oral antibiotics combined with topical treatments, and oral isotretinoin were the most cost-effective. Results showed uncertainty, as reflected in the wide confidence intervals around mean treatment rankings. CONCLUSION: A range of treatments are cost-effective for the management of acne. Well-conducted studies are needed to examine the long-term clinical efficacy and cost-effectiveness of the full range of acne treatments.

Exploring the costs associated with isotretinoin treatment.

The multistep process to obtain an isotretinoin prescription under the iPLEDGE program is challenging for patients, particularly female patients. This retrospective study evaluates the differences in treatment and costs between male and female patients. While male patients had a higher total cost of treatment than female patients, female patients had a higher treatment cost when medication costs were excluded. Female patients who missed prescription windows had a longer treatment course and incurred significantly higher treatment costs than female patients who did not miss a prescription window. The iPLEDGE program places female patients at a disadvantage of incurring higher treatment costs as a consequence of the prescription window requirement.

Parametric Acne Severity (PAS) Score and Lesion Counts From Multi-Modality Facial Image Analysis Correlates Strongly with Investigator Assessment.

Variability in acne lesion counting and assessing global severity necessitates large sample sizes that increase trial costs. Lack of standardized measures for these outcomes precludes the conduct of meta-analyses needed to compare efficacy of acne treatments. The goal of this study was to evaluate objective measures of lesion counts and global severity using analysis of multimodal photography. An algorithm for counting lesions was trained and validated in 30 acne subjects and compared to parallel assessments by 2 expert raters. A composite of photographic data representative of acne lesion topography, erythema, and C Acnes fluorescence was used to generate a Parametric Acne Severity (PAS) score. No relationship was identified between lesion counts and IGA. The correlation coefficients between raters and the algorithm when compared per view for the inflammatory and non-inflammatory lesion counts were 0.77 (P=0.001) and 0.85 (P=0.001), respectively. The correlation coefficient between the raters’ IGA grades and the PAS score was 0.82 (P<0.05). These data demonstrate that the lesion counting, and PAS are objective measures that strongly correlate with investigator assessments. Inclusion of these measure in clinical trials may reduce variability, standardize outcomes, and provide insights into treatment effects on photographic parameters associated with acne. J Drugs Dermatol. 2021;20(6):642-647. doi:10.36849/JDD.6165.

The assessment of psychology, quality of life in acne patients and evaluation of ALA-PDT for moderate to severe acne.

OBJECTIVE: To evaluate the state of psychology and quality of life of patients effected by acne and also the efficacy and safety of photodynamic therapy with topical 5-aminolevulinic acid (ALA-PDT) for moderate to severe acne patients. METHODS: In the questionnaire part, a pre-designed form was filled out. The questionnaire was comprised of 2 sections related to acne including sociodemographic and disease information as well as Cardiff Acne Disability Index (CADI) and Self-Rating Anxiety Scale (SAS). In the trial part, the ALA-PDT was applied to moderate to severe acne patients. Fresh 5% ALA solution was topically applied to face or face & neck. After 1 h's incubation, a LED device was illuminated. A power density of 60-100 mW/cm2 was delivered for 20 min. All the patients finished 3-4 sessions of ALA-PDT at 7-10 days intervals. Non-invasive detections were taken for skin moisture, oil, and VISIA indexes. Adverse events were recorded during and after the treatment. RESULTS: A total of 247 acne patients finished questionnaires. Over 97 % patients were assessed as mild to severe impacts in CADI questionnaire and 37.6 % patients had various degrees of anxiety in SAS questionnaire. The higher the BMI was, the higher the CADI points were (G = 0.278, p = 0.005). The severity of acne was correlated with psychology and quality of life (CADI: G = 0.367, p = 0.000; SAS: G = 0.285, p = 0.003). A total of 116 patients with moderate or severe acne accepted ALA-PDT and completed at least 3 sessions (PDT3) or even PDT4. After 1 session of treatment (AT1) and AT2, the efficiencies of all patients were 5.2 % and 29.3 %. For patients with PDT3, the efficiencies at follow-up at 1st month after last session (FU1), FU2 and FU3 were 59.4 %, 66.7 % and 78.3 %, respectively. For patients with PDT4, the efficiencies at AT3 and FU1-3 were 51.3 %, 63.6 %, 76.5 % and 85.7 %, respectively. The efficacies of PDT4 patients showed an increasing trend from FU1 to FU3 (G = 0.480, p = 0.004). Acne lesions of mild to severe were correlated with the treatment efficacies (FU1: G = 0.354, p = 0.000; FU2: G = 0.474, p = 0.000; FU3: G = 0.397, p = 0.000). Nearly 15 % patients were followed up for 12 months and among them 52.9 % patients were able to maintain ≥90 % improvement rate. There were no statistically significant differences before and after treatment (p > 0.05) according to the skin moisture content, oil content, ultraviolet ray spots, brown spots, red areas, and purple textures measured. The adverse reactions of ALA-PDT, including local burning sensation, mild pain sensation, mild edema erythema, reactive acne, pigmentation, etc., were temporary and tolerable. CONCLUSION: In our study, 97.2 % patients were rated as impact in CADI questionnaire and 37.6 % patients had anxiety in SAS questionnaire. It is necessary to control weight and disease progression. The efficiencies of ALA-PDT for moderate and severe acne were 59.4%-85.7% at follow-ups of 1st, 2nd or 3rd month after last session. The adverse reactions of ALA-PDT were temporary and tolerable.

Psychiatric disorders and suicidal behavior in patients with acne prescribed oral antibiotics versus isotretinoin: Analysis of a large commercial insurance claims database.

BACKGROUND: The association between isotretinoin and psychiatric disturbance, including depression and suicidal behavior, is controversial. OBJECTIVE: To investigate whether acne patients prescribed isotretinoin or antibiotics were more likely to have psychiatric disorders and/or engage in suicidal behavior. METHODS: Retrospective cohort study using the IBM MarketScan Research Databases, which contain commercial insurance claims in the United States, to identify acne patients who were prescribed isotretinoin or oral antibiotics between 2011 and 2017 and who were diagnosed with psychiatric disorders or suicidal behavior. RESULTS: A total of 72,555 patients were included in the study. Patients in the general population were 1.47 times more likely to be diagnosed with suicidal ideation or attempt compared to acne patients prescribed isotretinoin (adjusted odds ratio [OR] 1.47; confidence interval [95% CI], 1.27, 1.70; P < .0001). The general population (adjusted OR 0.87; 95% CI, 0.84, 0.89; P < .0001) and acne patients prescribed antibiotics (adjusted OR 0.88; 95% CI, 0.85, 0.91; P < .0001) were less likely to have a psychiatric diagnosis compared to acne patients prescribed isotretinoin. The prevalence of suicidal behavior during isotretinoin treatment was lower (0.10%; P = .082) than in the year prior to isotretinoin treatment (0.22%) and in the year following treatment (0.34%; P = .004). LIMITATIONS: The study excluded individuals with public insurance and those who were uninsured, and the data in the study relied on the accuracy of the medical coding. CONCLUSIONS: Compared to the general population, acne patients prescribed isotretinoin were less likely to engage in suicidal behavior. Further exploration into the slight increase in suicidal behavior seen in isotretinoin patients 1 year after therapy is warranted.