Formaldehyde 2% is not a useful means of detecting allergy to formaldehyde releasers- results of the ESSCA network, 2015-2018.

BACKGROUND: Studies suggest that patch testing with formaldehyde releasers (FRs) gives significant additional information to formaldehyde 1% aq. and should be considered for addition to the European baseline series (EBS). It is not known if this is also true for formaldehyde 2% aq. OBJECTIVES: To determine the frequency of sensitization to formaldehyde 2% aq. and co-reactivity with FRs. To establish whether there is justification for including FRs in the EBS. MATERIALS AND METHODS: A 4-year, multi-center retrospective analysis of patients with positive patch test reactions to formaldehyde 2% aq. and five FRs. RESULTS: A maximum of 15 067 patients were tested to formaldehyde 2% aq. and at least one FR. The percentage of isolated reactions to FR, without co-reactivity to, formaldehyde 2% aq. for each FR were: 46.8% for quarternium-15 1% pet.; 67.4% imidazolidinyl urea 2% pet.; 64% diazolidinyl urea 2% pet.; 83.3% 1,3-dimethylol-5, 5-dimethyl hydantoin (DMDM) hydantoin 2% pet. and 96.3% 2-bromo-2-nitropropane-1,3-diol 0.5% pet. This demonstrates that co-reactivity varies between FRs and formaldehyde, from being virtually non-existent in 2-bromo-2-nitropropane-1,3-diol 0.5% pet. (Cohen's kappa: 0, 95% confidence interval [CI] -0.02 to 0.02)], to only weak concordance for quaternium-15 [Cohen's kappa: 0.22, 95%CI 0.16 to 0.28)], where Cohen's kappa value of 1 would indicate full concordance. CONCLUSIONS: Formaldehyde 2% aq. is an inadequate screen for contact allergy to the formaldehyde releasers, which should be considered for inclusion in any series dependant on the frequency of reactions to and relevance of each individual allergen.

Identifying the Impacts of Acne and the Use of Questionnaires to Detect These Impacts: A Systematic Literature Review.

BACKGROUND: Acne (syn: acne vulgaris) ranks as the most common inflammatory dermatosis treated worldwide. Acne typically affects adolescents at a time when they are undergoing maximum physical and social transitions, although prevalence studies suggest it is starting earlier and lasting longer, particularly in female patients. According to global burden of disease studies, acne causes significant psychosocial impact. Hence, identifying mechanisms to accurately measure the impact of the disease is important. Adopting an approach to harmonize and standardize measurements is now recognized as an essential part of any clinical evaluation and allows for better comparison across studies and meta-analyses. OBJECTIVE: The Acne Core Outcome Research Network (ACORN) has identified relevant domains as part of a core outcome set of measures for use in clinical studies. One of these is health-related quality of life (HRQoL). The aim of this systematic review was to provide information to inform the identification of the impacts most important to people with acne. METHODS: A synthesis of available evidence on acne impacts was constructed from a systematic review of the literature, with searches conducted in the MEDLINE, EMBASE and PsychInfo databases. RESULTS: We identified 408 studies from 58 countries using 138 different instruments to detect the impacts of acne. Four of the five most commonly used instruments (Dermatology Life Quality Index [DLQI], Cardiff Acne Disability Index [CADI], Acne Quality of Life scale [Acne-QoL], Hospital Anxiety and Depression Scale [HADS] and Skindex-29) do not identify specific impacts but rather quantify to what extent acne affects HRQoL. Other studies identified one or more impacts using open-ended questions or tailor-made questionnaires. CONCLUSION: This review serves as a rich data source for future efforts by groups such as ACORN (that include patients and health care providers) to develop a core set of outcome measurements for use in clinical trials.

Prioritizing treatment outcomes: How people with acne vulgaris decide if their treatment is working.

OBJECTIVE: To collect information about how people with acne make day-to-day decisions concerning the effectiveness of their treatment. METHODS: Between May and August 2013, an optional question was embedded in the James Lind Alliance Acne Priority Setting Partnership's online survey to collect treatment uncertainties. The question asked people with acne to "Tell us in your own words how you decide if your treatment has been effective." RESULTS: A total of 742 respondents specified at least one outcome or means of assessing change (outcome measure). Fewer spots were the most commonly cited outcome, identified by 272 respondents (36.7%). Other frequently mentioned outcomes were in descending order: less redness (19.4%), reduction in spot size (12.1%), and less pain/discomfort (11.4%). Signs were much more commonly used than symptoms and surrogate outcomes such as changes in aspects of life quality were infrequently mentioned. Visual inspection of the skin was the most widely adopted outcome measure (16.3%). CONCLUSIONS: Although the most frequently used methods map well onto the outcome measures adopted in the majority of acne trials, namely physician-assessed changes in lesion counts and global acne severity, people with acne often take into account several factors that cannot be assessed by a third party at a single point in time. The minimal use of changes in psychosocial wellbeing and mood may reflect that these are regarded as secondary consequences of improvements in appearance. The robustness of these findings now requires independent evaluation. If confirmed, they could form the basis of a new patient-reported outcome measure.

Oral Spironolactone for Acne Vulgaris in Adult Females: A Hybrid Systematic Review.

BACKGROUND: The management of acne in adult females is problematic, with many having a history of treatment failure and some having a predisposition to androgen excess. Alternatives to oral antibiotics and combined oral contraceptives (COCs) are required. OBJECTIVE: Our aim was to conduct a hybrid systematic review of the evidence for benefits and potential harms of oral spironolactone in the management of acne in adult females. METHODS: The review was conducted according to a previously published protocol. Three reviewers independently selected relevant studies from the search results, extracted data, assessed the risk of bias, and rated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: Ten randomized controlled trials (RCTs) and 21 case series were retrieved. All trials were assessed as being at a 'high risk' of bias, and the quality of evidence was rated as low or very low for all outcomes. Apart from one crossover trial that demonstrated statistical superiority of a 200 mg daily dose versus inflamed lesions compared with placebo, data from the remaining trials were unhelpful in establishing the degree of efficacy of lower doses versus active comparators or placebo. Menstrual side effects were significantly more common with the 200 mg dose; frequency could be significantly reduced by concomitant use of a COC. Pooling of results for serum potassium supported the recent recommendation that routine monitoring is not required in this patient population. CONCLUSION: This systematic review of RCTs and case series identified evidence of limited quality to underpin the expert endorsement of spironolactone at the doses typically used (≤100 mg/day) in everyday clinical practice.

Identifying acne treatment uncertainties via a James Lind Alliance Priority Setting Partnership.

OBJECTIVES: The Acne Priority Setting Partnership (PSP) was set up to identify and rank treatment uncertainties by bringing together people with acne, and professionals providing care within and beyond the National Health Service (NHS). SETTING: The UK with international participation. PARTICIPANTS: Teenagers and adults with acne, parents, partners, nurses, clinicians, pharmacists, private practitioners. METHODS: Treatment uncertainties were collected via separate online harvesting surveys, embedded within the PSP website, for patients and professionals. A wide variety of approaches were used to promote the surveys to stakeholder groups with a particular emphasis on teenagers and young adults. Survey submissions were collated using keywords and verified as uncertainties by appraising existing evidence. The 30 most popular themes were ranked via weighted scores from an online vote. At a priority setting workshop, patients and professionals discussed the 18 highest-scoring questions from the vote, and reached consensus on the top 10. RESULTS: In the harvesting survey, 2310 people, including 652 professionals and 1456 patients (58% aged 24 y or younger), made submissions containing at least one research question. After checking for relevance and rephrasing, a total of 6255 questions were collated into themes. Valid votes ranking the 30 most common themes were obtained from 2807 participants. The top 10 uncertainties prioritised at the workshop were largely focused on management strategies, optimum use of common prescription medications and the role of non-drug based interventions. More female than male patients took part in the harvesting surveys and vote. A wider range of uncertainties were provided by patients compared to professionals. CONCLUSIONS: Engaging teenagers and young adults in priority setting is achievable using a variety of promotional methods. The top 10 uncertainties reveal an extensive knowledge gap about widely used interventions and the relative merits of drug versus non-drug based treatments in acne management.