Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne.

Importance: Treatment satisfaction is important to achieving therapeutic success in patients with inflammatory dermatological diseases, such as acne. Objective: To evaluate the structural validity, internal consistency, and construct validity of the DermSat-7, a questionnaire-based measure of treatment satisfaction, in patients with acne seen in routine clinical practice. Design, Setting, and Participants: This cross-sectional study included adults with acne who were fluent in English and treated at an outpatient clinic at Brigham and Women's Hospital between July 2022 and May 2023. At each visit, patients completed a self-administered, patient-reported outcome questionnaire, including a patient global assessment (PGA) of their acne severity and the DermSat-7. The DermSat-7 consists of 7 items assessing 3 domains of treatment: effectiveness (3 items), convenience (3 items), and overall satisfaction (1 item). At subsequent visits, patients were asked an anchor item related to change in disease severity ("How has your acne changed compared to your last visit?") that was scored on a 7-point scale (-3 = much worse to 3 = much better). Also at each visit, a dermatologist completed the Comprehensive Acne Severity Scale (CASS). Main Outcomes and Measures: The main outcomes were structural validity (assessed by factor analysis), internal consistency (assessed by Cronbach α), and construct validity (assessed using linear regression models and Pearson correlation coefficients). Results: The analysis included 142 patients with acne (mean [SD] age, 25.1 [5.1] years; 96 females [67.6%]) taking acne medication who completed the DermSat-7. Exploratory factor and confirmatory factor analysis supported the unidimensionality of the 3 DermSat-7 domains. Cronbach α values of 0.89 and 0.80 supported good internal consistency in the effectiveness and convenience domains, respectively. Known-groups validity was supported by increasing DermSat-7 effectiveness and overall satisfaction scores with increasing levels of positive change in disease severity (linear regression coefficient, 7.51; 95% CI, 4.94-10.08; P < .001). Construct validity was further supported by moderate correlations with the anchor, PGA, and CASS scores (effectiveness domain: anchor r = 0.567, PGA r = -0.538, and CASS r = -0.485; overall satisfaction domain: anchor r = 0.467, PGA r = -0.486, and CASS r = -0.489). Conclusion and Relevance: This cross-sectional study found that the DermSat-7 may be an effective tool for measuring treatment satisfaction, particularly effectiveness and overall satisfaction domains, among patients with acne. Further research is needed to examine additional measurement properties of the DermSat-7, such as content validity and interpretability, as well as to validate the DermSat-7 in other populations of patients with acne.

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).

Factors that influence women's enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial.

BACKGROUND: The use of decentralised clinical trials (which bring trials to patients through remote processes and technology versus central on-site visits) has been thought to be a potential solution to common recruitment and retention barriers. However, there is a lack of evidence to understand the experiences, needs and preferences of the public to inform trial methodologies that appeal to different populations. We report participant experiences of SAFA, a partially decentralised randomised clinical trial, to inform the methodology used in future dermatology trials that aim to appeal to women aged 18 and over. METHODS: Participants of the SAFA (Spironolactone for Adult Female Acne) trial were invited to take part in a qualitative semi-structured interview to explore their experience and perspectives of taking part in the trial. Questions focused on their experience of using decentralised methods to access and enrol in the trial (e.g. social media advertising), in addition to the decentralised trial visit and data collection methods used throughout. Interviews were conducted remotely, recorded, and transcribed. Data were analysed using reflexive thematic analysis. RESULTS: Twelve SAFA participants (all women, age range 22-36 years) were interviewed. Initially, participants were influenced to enrol by trusted online information, the feeling of validation the trial provided, and the convenience and flexibility offered by the decentralised methods and research staff made participants feel valued and enabled them to engage in the trial with minimal interference to existing commitments. SAFA participants were generally accepting of trial demands, such as the text-heavy paperwork and on-site visits for blood collection and highlighted several areas relevant for trial conduct going forwards including where decentralised methods may (and may not) be accepted and how trial accessibility and understanding could be improved. CONCLUSIONS: The study has shown that decentralised methods used by responsive and approachable staff were widely accepted in the SAFA trial. Interviewees found the methods adopted in the SAFA trial helped the trial to fit with their needs and promoted a sense of feeling valued that encouraged ongoing trial engagement. Decentralised methods should be considered favourably when designing a dermatology trial as they can potentially enhance both recruitment and retention. TRIAL REGISTRATION NUMBER: ISRCTN 12892056. Registered on October 15, 2018.

Systematic review of clinical practice guidelines for acne vulgaris published between January 2017 and July 2021.

Background: Acne is very common, can cause considerable negative impact on quality of life and there is increasing concern over the use of long courses of oral antibiotics for this condition. Objectives: (1) To critically appraise reporting in acne guidelines and compare this with previous systematic review of acne guidelines. (2) Examine acne treatment guidance on pre-specified acne treatments of interest and compare between acne guidelines. Methods: Searches for new or updated guidelines were carried out in MEDLINE, Embase, Google Scholar, LILACS from 1 January 2017 to 31 July 2021, supplemented by searching a guideline-specific depository and checking for updates to guidelines included in previous review. We included guidelines, consensus statements or care protocols on the medical treatment of acne vulgaris in adults and/or children and excluded those that focused on a single intervention or subgroup of acne, regional adaptations of guidelines or guidelines included in previous review. AGREE II checklist was applied to critically appraise reporting of guidelines. Results were synthesised narratively. Results: Of 807 abstracts identified nine guidelines were identified that were eligible for inclusion. All guidelines had AGREE II scores above average in at least one domain and reporting was substantially improved compared to the systematic review of acne carried out 5 years previously. There was consensus between guidelines on the key role of topical treatments as first-line acne treatment and most recommended continuing topical treatments as maintenance therapy. There was considerable variation between guidelines on classification of severity, indications for commencing oral antibiotics and on maximum duration of oral antibiotics. However, there was consensus on the need for co-prescription of a non-antibiotic topical treatment when using oral antibiotics. There were notable differences on recommendations regarding provision of information for patients on how to use topical treatments or how to mitigate against side effects. Conclusions: Substantial differences in classification of acne severity hampered comparisons between guidelines. Although development and reporting of guidelines has improved over the past 5 years, differences in key recommendations remain, possibly reflecting uncertainties in the underlying evidence base. Differences between guidelines could have substantial implications for prevalence of antibiotic prescribing for acne.

The Personalized Acne Treatment Tool - Recommendations to facilitate a patient-centered approach to acne management from the Personalizing Acne: Consensus of Experts.

Background: Acne, a commonly treated skin disease, requires patient-centered management due to its varying presentations, chronicity, and impact on health-related quality of life. Despite this, evidence-based clinical guidelines focus primarily on clinical severity of facial acne, omitting important patient- and disease-related factors, including ongoing management. Objectives: To generate recommendations to support patient-centered acne management, which incorporate priority and prognostic factors beyond conventional clinical severity, traditionally defined by grading the appearance and extent of visible lesions. Methods: The Personalizing Acne: Consensus of Experts consisted of 17 dermatologists who used a modified Delphi approach to reach consensus on statements regarding patient- and treatment-related factors pertaining to patient-centered acne management. Consensus was defined as ≥75% voting "agree" or "strongly agree." Results: Recommendations based on factors such as acne sequelae, location of acne, high burden of disease, and individual patient features were generated and incorporated into the Personalized Acne Treatment Tool. Limitations: Recommendations are based on expert opinion, which may differ from patients' perspectives. Regional variations in healthcare systems may not be represented. Conclusions: The Personalizing Acne: Consensus of Experts panel provided practical recommendations to facilitate individualized management of acne, based on patient features, which can be implemented to improve treatment outcomes, adherence, and patient satisfaction.

Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial.

OBJECTIVE: To assess the effectiveness of oral spironolactone for acne vulgaris in adult women. DESIGN: Pragmatic, multicentre, phase 3, double blind, randomised controlled trial. SETTING: Primary and secondary healthcare, and advertising in the community and on social media in England and Wales. PARTICIPANTS: Women (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics. INTERVENTIONS: Participants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment. MAIN OUTCOME MEASURES: Primary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12 (range 0-30, where higher scores reflect improved QoL). Secondary outcomes were Acne-QoL at week 24, participant self-assessed improvement; investigator's global assessment (IGA) for treatment success; and adverse reactions. RESULTS: From 5 June 2019 to 31 August 2021, 1267 women were assessed for eligibility, 410 were randomly assigned to the intervention (n=201) or control group (n=209) and 342 were included in the primary analysis (n=176 in the intervention group and n=166 in the control group). Baseline mean age was 29.2 years (standard deviation 7.2), 28 (7%) of 389 were from ethnicities other than white, with 46% mild, 40% moderate, and 13% severe acne. Mean Acne-QoL symptom scores at baseline were 13.2 (standard deviation 4.9) and at week 12 were 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo (difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46), adjusted for baseline variables). Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo (difference 3.45 (95% confidence interval 2.16 to 4.75), adjusted). More participants in the spironolactone group reported acne improvement than in the placebo group: no significant difference was reported at week 12 (72% v 68%, odds ratio 1.16 (95% confidence interval 0.70 to 1.91)) but significant difference was noted at week 24 (82% v 63%, 2.72 (1.50 to 4.93)). Treatment success (IGA classified) at week 12 was 31 (19%) of 168 given spironolactone and nine (6%) of 160 given placebo (5.18 (2.18 to 12.28)). Adverse reactions were slightly more common in the spironolactone group with more headaches reported (20% v 12%; p=0.02). No serious adverse reactions were reported. CONCLUSIONS: Spironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne. TRIAL REGISTRATION: ISRCTN12892056.

Real-World Case Studies Showing the Effective Use of Azelaic Acid in the Treatment, and During the Maintenance Phase, of Adult Female Acne Patients.

Acne Vulgaris is a chronic inflammatory skin disease, and one of the most prevalent inflammatory dermatoses among teenagers, affecting more than >95% of boys and 85% of girls. Adult female acne (AFA) is a subtype of acne, pragmatically defined as affecting women over the age of 25. The clinical presentation of AFA may be distinguished from adolescent acne according to some key clinical and psychosocial characteristics. The etiopathogenic factors and the chronic clinical course that are implicated in AFA make management complex and challenging. A frequent tendency to relapse makes the requirement for maintenance therapy highly likely. Therefore, AFA typically requires a specific, tailored therapeutic approach. This paper presents six challenging case studies that demonstrate the efficacy of azelaic acid gel (AZA) in adult female acne. The six cases use AZA as monotherapy, as part of a combination regimen at treatment initiation, or as maintenance treatment (which is frequently required in this adult population). The positive outcomes achieved in this case series demonstrate that AZA can be efficacious, result in excellent patient satisfaction in mild to moderate adult female acne, and can be effective as a maintenance therapy.

Adolescent acne vulgaris: current and emerging treatments.

Acne vulgaris is one of the commonest inflammatory skin diseases seen worldwide, affecting all ethnicities and races, with a peak prevalence between age 15 years and 20 years. The burden of this condition, and the resulting clinical and psychological sequelae, is substantial. The visual appearance of acne and its sequelae, including scarring and pigment changes, frequently results in psychological and social morbidity because of concerns about appearance. As understanding of the pathophysiology has evolved, approaches to achieving the optimal outcomes with effective treatment regimens continue to emerge. In the past few years, several novel therapeutics have been developed, including new agents aimed at reducing antimicrobial resistance and products with specific actions targeting retinoid receptors and androgen receptors. This Review considers the management approaches of an adolescent with acne vulgaris and reviews treatment options from the evidence base and international expert opinion. Approaches to selecting current treatments and novel and emerging treatment regimens are discussed.

Adapalene/benzoyl peroxide gel 0.3%/2.5% for acne vulgaris

Acne vulgaris is typically treated with a combination of a topical retinoid plus an antimicrobial agent, as recommended by national and international evidence-based guidelines around the globe. Adapalene, a synthetic topical retinoid, is available in two concentrations (0.1% and 0.3%) and in once-daily fixed-dose combinations with benzoyl peroxide (BPO) 2.5%. Adapalene 0.3%/BPO 2.5% is approved for use for moderate-to-severe acne with proven efficacy, good safety and tolerability across a spectrum of patient variables (different ages, genders, and skin types) and disease severity. While some patients experience issues with transient tolerability during retinoid and BPO therapy, it is our clinical experience that good patient education to set expectations and provide strategies to minimize irritation can overcome the majority of issues. This article reviews the data supporting the use of adapalene 0.3%/2.5% in practice, including the complementary mechanism of action of adapalene and BPO, clinical data from a range of settings, and key aspects of patient education.

Prevalence and Demographics of Truncal Involvement Among Acne Patients: Survey Data and a Review of the Literature.

Background: Truncal acne is frequently underdiagnosed despite affecting around half of those with facial acne. The objective was to provide an overview of the literature on the incidence of truncal acne according to age, gender, and acne severity. Methods: A narrative review of data from recent large surveys and a literature search in PubMed on the incidence of truncal acne across subgroups of age, gender, and acne severity. Results: The prevalence of truncal acne alone was low, ranging from <1% to 14%, but approximately 30 to 60 percent of individuals with facial acne also had truncal acne depending on the population. In an online survey in the United States of 2,000 respondents aged between 14 -29 years with self-reported active facial and/or truncal acne, the incidence of truncal acne was lower in the 14-20 years subgroup than in the 21-29 years subgroup (49% vs 54%). The incidence of truncal acne was similar in both males and females, while 46 percent of respondents with self-declared clear and mild acne indicated having truncal involvement compared to 60 percent of those with moderate or severe acne. Limitations: Online surveys have inherent limitations, such as self-reporting and potential confounders. Conclusion: Data suggests that patients with both facial and truncal involvement have earlier onset of acne and more severe acne. Additional adverse psychological impact may arise from having the impression that the disease is spreading and becoming more severe. Raising awareness of truncal acne prevalence and demographics could improve its clinical management to reduce the negative psychological impact.

The Synergy between Pharmacological Regimens and Dermocosmetics and Its Impact on Adherence in Acne Treatment.

Background: Acne is the most common inflammatory skin disease in adolescence. It is also prevalent in adults, especially females. The disease has a considerable impact on health-related quality of life. Many studies have reported the negative impact of acne on patients due to skin disfigurement, ineffective treatment, and adverse effects of the treatment. Numerous factors contribute towards nonadherence to therapy. Summary. This review discusses the various factors that are related to treatment nonadherence such as ineffective therapy, adverse effects with topical pharmacotherapy such as skin irritation and erythema as well as patient-related factors such as lack of knowledge of disease and a poor patient-physician relationship. Various methods are being adopted to increase adherence to treatments. Increased adherence to acne therapy has been associated with the use of dermocosmetics, such as moisturizers and cleansers. Encouraging the use of dermocosmetics in synergy with pharmacological regimens could support improved treatment adherence resulting in better clinical outcomes for acne patients. Conclusion: Dermocosmetics as an adjunct to pharmacological regimens has the potential to improve clinical outcomes by increasing treatment adherence in patients with acne.

Evaluation of Psychological Wellbeing and Social Impact of Combined Facial and Truncal Acne: a Multi-national, Mixed-Methods Study.

INTRODUCTION: Half of the individuals with facial acne develop truncal acne, but the impact of combined facial and truncal acne (CA) on patients' quality of life is poorly researched. METHODS: A 60-min interview of 30 participants with CA was conducted that formed the basis for a cross-sectional survey of 694 adolescents and adults with CA. RESULTS: The main themes identified from the qualitative interviews among CA subjects included acceptability to self and others, social functioning and emotional wellbeing. Feelings of embarrassment, self-consciousness and low confidence were experienced often or all the time by over 50% of participants, and were more frequent in those who perceived their acne to be out of control (P = 0.003). Half of patients reported feeling stigmatised because of their CA, and 65.4% believed that others associated their truncal acne with unhealthy or unhygienic habits. Perceived stigma was associated with more feelings of embarrassment (P = 0.005), self-consciousness (P = 0.034) and low self-confidence (P = 0.017). Overall, 64% participants reported that CA interfered with daily life, 46.4% often or always avoided social interaction, 48.6% were often concerned about talking to unfamiliar people and 47.4% were uncomfortable showing affection. Further, 32% and 24.4% participants ≥ 16 years old avoided dating or having romantic/intimate relationships because of their facial and truncal acne, respectively. Social and leisure activities were more frequently negatively impacted among those with perceived uncontrolled CA than among those with controlled CA. Avoiding undressing in front of spouse/partner/friends/relatives was more commonly reported by participants with perceived uncontrolled truncal acne than by those with controlled truncal acne (90.5% versus 80.6%, P = 0.031). CONCLUSION: CA is associated with considerable psychological morbidity, with several exacerbating (e.g. perceived stigma) and attenuating factors (e.g. acne being perceived as being under control) that should be accounted for in CA management.

Patient and Public Involvement in Dermatology Research: A Review.

Patient and public involvement (PPI) in research is defined as research being carried out 'with' or 'by' members of the public, patients, and carers, on both an individual and a group level, rather than simply 'about', or 'for' them. Within dermatology, PPI is increasingly recognised as a vital component of research as it helps to ensure that research remains relevant to the populations we intend to serve. Dermatology scholarship, with its rich psychosocial implications due to the stigma, physical disability, and mental health burdens these conditions may incur, is in a unique position to benefit from PPI to unlock previously inaccessible patient lived experiences or therapeutic consequences. Throughout the rapid growth of PPI, it has been infused throughout the research lifecycle, from design to dissemination and beyond. After first explaining the principles of PPI, we examine the existing evidence base at each research stage to explore whether our specialty has effectively harnessed this approach and to identify any subsequent impact of PPI. Finally, we scrutinise the challenges faced by those implementing PPI in dermatology research.