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Background The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed upon the Core Outcome Set (COS) for use in atopic dermatitis (AD) clinical trials, but additional guidance is needed to maximize its uptake. Objectives To provide answers to some of the commonly asked questions about using the HOME COS; to provide data to help with the interpretation of trial results; and to support sample size calculations for future trials. Methods and results We provide practical guidance on the use of the HOME COS for investigators planning clinical trials in patients with AD. It answers some of the common questions about using the HOME COS, how to access the outcome measurement instruments, what training/resources are needed to use them appropriately and clarifies when the COS is applicable. We also provide exemplar data to inform sample size calculations for eczema trials and encourage standardized data collection and reporting of the COS. Conclusions By encouraging adoption of the COS and facilitating consistent reporting of outcome data, it is hoped that the results of eczema trials will be more comprehensive and readily combined in meta-analyses and that patient care will subsequently be improved. [ABSTRACT FROM AUTHOR]

This document is a commentary on a comparative randomized clinical trial that evaluated the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment for atopic dermatitis in children. The authors commend the study for comparing the effects of these treatments and providing useful data on adverse events. However, they raise concerns about the trial duration, choice of primary outcomes, randomization process, sample size rationale, lack of blinding, implausibility of skin atrophy data, and ethical concerns. The authors suggest that better reporting following the CONSORT statement could have rectified some of these concerns. [Extracted from the article]

Summary: In Part 1 of this 2‐part review of the 20th anniversary of the UK Dermatology Clinical Trials Network (UK DCTN), we described its role in developing and supporting clinical trial proposals, elaborating on structure, process and clinical trials activity. This review describes the diverse educational and training activities that the UK DCTN supports. Although not primarily set up as an educational organization, an education and training function emerged organically as the network grew. Education and training also embodies the democratization principle that drove the formation of the UK DCTN, allowing participation from a much wider group of individuals than just senior academics. Far from being a sideline, education and training has now become a major component of the UK DCTN that evolves constantly through changing training curricula and trial methodology developments. Formal UK DCTN training opportunities started in 2007 with competitively awarded annual fellowships for dermatology trainees, followed by similar schemes for general practitioners, Staff and Associate Specialist clinicians and dermatology nurses. These were followed in 2013 by larger groups of trainees who work up specific trial proposals with senior mentors. Finally, a virtual journal club emerged during the pandemic in 2020 in order to reach trainees with little access to academic training. Focused activities with dermatological nurses and patients/carers also take place. Such activities require considerable organization and volunteerism from the co‐ordinating centre and former fellows. Education and training has become an essential component for capacity building to develop clinical trials and succession planning for the UK DCTN. [ABSTRACT FROM AUTHOR]

Summary: The UK Dermatology Clinical Trials Network (UK DCTN) was formed in 2002 with the aim of developing and supporting high‐quality independent national clinical trials that address prioritized research questions for people with skin disease. Its philosophy is to democratize UK dermatological clinical research and to tackle important clinical questions that industry has no incentive to answer. The network also plays a key role in training and capacity development. Its membership of over 1000 individuals includes dermatology consultants, trainees, dermatology nurses, general practitioners, methodologists and patients. Its organizational structures are lean and include a co‐ordinating team based at the Centre of Evidence‐Based Dermatology in Nottingham, and an executive with independent members to ensure probity and business progression. A prioritization panel and steering group enable a pipeline of projects to be prioritized and refined for external funding from independent sources. The UK DCTN has supported and completed 12 national clinical trials, attracting investment of over £15 million into UK clinical dermatology research. Trials have covered a range of interventions from drugs such as doxycycline (BLISTER), silk clothing for eczema (CLOTHES) and surgical interventions for hidradenitis suppurativa (THESEUS). Trial results are published in prestigious journals and have global impact. Genuine partnership with patients and carers has been a strong feature of the network since its inception. The UK DCTN is proud of its first 20 years of collaborative work, and aims to remain at the forefront of independent dermatological health technology assessment, as well as expanding into areas including diagnostics, artificial intelligence, efficient studies and innovative designs. [ABSTRACT FROM AUTHOR]

Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool. [ABSTRACT FROM AUTHOR]

Importance: Extenuating circumstances can trigger unplanned changes to randomized trials and introduce methodological, ethical, feasibility, and analytical challenges that can potentially compromise the validity of findings. Numerous randomized trials have required changes in response to the COVID-19 pandemic, but guidance for reporting such modifications is incomplete.Objective: As a joint extension for the CONSORT and SPIRIT reporting guidelines, CONSERVE (CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstances) aims to improve reporting of trial protocols and completed trials that undergo important modifications in response to extenuating circumstances.Evidence: A panel of 37 international trial investigators, patient representatives, methodologists and statisticians, ethicists, funders, regulators, and journal editors convened to develop the guideline. The panel developed CONSERVE following an accelerated, iterative process between June 2020 and February 2021 involving (1) a rapid literature review of multiple databases (OVID Medline, OVID EMBASE, and EBSCO CINAHL) and gray literature sources from 2003 to March 2021; (2) consensus-based panelist meetings using a modified Delphi process and surveys; and (3) a global survey of trial stakeholders.Findings: The rapid review yielded 41 673 citations, of which 38 titles were relevant, including emerging guidance from regulatory and funding agencies for managing the effects of the COVID-19 pandemic on trials. However, no generalizable guidance for all circumstances in which trials and trial protocols might face unanticipated modifications were identified. The CONSERVE panel used these findings to develop a consensus reporting guidelines following 4 rounds of meetings and surveys. Responses were received from 198 professionals from 34 countries, of whom 90% (n = 178) indicated that they understood the concept definitions and 85.4% (n = 169) indicated that they understood and could use the implementation tool. Feedback from survey respondents was used to finalize the guideline and confirm that the guideline's core concepts were applicable and had utility for the trial community. CONSERVE incorporates an implementation tool and checklists tailored to trial reports and trial protocols for which extenuating circumstances have resulted in important modifications to the intended study procedures. The checklists include 4 sections capturing extenuating circumstances, important modifications, responsible parties, and interim data analyses.Conclusions and Relevance: CONSERVE offers an extension to CONSORT and SPIRIT that could improve the transparency, quality, and completeness of reporting important modifications to trials in extenuating circumstances such as COVID-19. [ABSTRACT FROM AUTHOR]

This is the third article in a series relating to research and dermatology nursing, and describes why critical appraisal skills are necessary for dermatology nurses. It suggests a quick critical appraisal approach that can be used -- 'read, write and reflect'. The approach advises nurses to consider PICO, types of bias, and validity. The importance of utilising critical appraisal in practice is discussed, as well as the need for it to become a necessary skill for dermatology nurses. [ABSTRACT FROM AUTHOR]

The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. [ABSTRACT FROM AUTHOR]

Background: Cellulitis (erysipelas) is a recurring and debilitating bacterial infection of the skin and underlying tissue. We assessed the cost-effectiveness of prophylactic antibiotic treatment to prevent the recurrence of cellulitis using low dose penicillin V in patients following a first episode (6 months prophylaxis) and more recurrent cellulitis (12 months prophylaxis, or 6 months in those declining 12 months). Methods: Within-trial cost-effectiveness analysis was conducted using the findings of two randomised placebo-controlled multicentre trials (PATCH I and PATCH II), in which patients recruited in the UK and Ireland were followed-up for up to 3 years. Incremental cost, reduction in recurrence, cost per recurrence prevented and cost/QALY were estimated. National unit and reference costs for England in 2010 were applied to resource use, exploring NHS and societal perspectives. A total of 397 patients from the two trials contributed to the analysis. Results: There was a 29% reduction in the number of recurrences occurring within the trial (IRR: 0.71 95%CI: 0.53 to 0.90, p = 0.02), corresponding to an absolute reduction of recurrence of 0.31 recurrences/patient (95%CI: 0.05 to 0.59, p = 0.02). Incremental costs of prophylaxis suggested a small cost saving but were not statistically significant, comparing the two groups. If a decision-maker is willing to pay up to £25,000/QALY then there is a 66% probability of antibiotic prophylaxis being cost-effective from an NHS perspective, rising to 76% probability from a secondary, societal perspective. Conclusion: Following first episode or recurrent cellulitis of the leg, prophylactic low dose penicillin is a very low cost intervention which, on balance, is effective and cost-effective at preventing subsequent attacks. Antibiotic prophylaxis reduces cellulitis recurrence by nearly a third but is not associated with a significant increase in costs. [ABSTRACT FROM AUTHOR]

Randomized controlled clinical trials remain the best method for minimizing bias when evaluating dermatological treatments. Many dermatologic clinical trials have suffered from small sample sizes, selective reporting of outcomes, publication bias, poor reporting, and heterogeneous outcomes that have hampered comparability-deficiencies that can be overcome by adopting good trial planning and reporting practice encouraged by this journal. Although a profusion of explanatory placebo-controlled studies have contributed little to decision making in the clinical setting, some comparative effectiveness trials such as the use of topical corticosteroids for pemphigoid may have played a pivotal role in improving the well-being of dermatological patients. Systematic reviews (SRs) of clinical trials strive to organize the entire body of evidence while minimizing bias so that policy makers and guideline developers can base their recommendations on the appropriate strength and level of evidence. In dermatology, SRs, such as those undertaken by the Cochrane Collaboration, have produced clear clinical messages despite conflicting individual studies, and also play a key role in identifying research gaps. Future challenges include optimizing the use of research resources, adopting methodological developments in health technology assessment, and prospective registration and complete reporting of all study results. [ABSTRACT FROM AUTHOR]

Background: The SINS trial (Controlled Clinical Trials ISRCTN48755084; Eudract No. 2004-004506-24) is a randomised controlled trial evaluating long term success of excisional surgery vs. imiquimod 5% cream for low risk nodular and superficial basal cell carcinoma (BCC). The trial included a discrete choice experiment questionnaire to explore patient preferences of a cream versus surgery for the treatment of their skin cancer. Methods: The self-completed questionnaire was administered at baseline to 183 participants, measuring patients’ strength of preferences when choosing either alternative ‘surgery’ or ‘imiquimod cream’ instead of a fixed ‘current situation’ option (of surgical excision as standard practice in UK). The treatments were described according to: cost, chance of complete clearance, side effects and appearance. Participants had to choose between various scenarios. Analysis was performed using a mixed logit model, which took into account the impact of previous BCC treatment and sample preference variability. Results: The analysis showed that respondents preferred ‘imiquimod cream’ to their ‘current situation’ or ‘surgery’, regardless of previous experience of BCC symptoms and treatment. Respondents were more likely to be worried about their cosmetic outcomes and side effects they might experience over and above their chance of clearance and cost. Those with no experience of surgery (compared with experience) valued more the choice of ‘imiquimod cream’ (£1013 vs £781). All treatment characteristics were significant determinants of treatment choice, and there was significant variability in the population preferences for all of them. Conclusions: Patients with BCC valued more ‘imiquimod cream’ than alternative ‘surgery’ options, and all treatment characteristics were important for their choice of care. Understanding how people with a BCC value alternative interventions may better inform the development of health care interventions. [ABSTRACT FROM AUTHOR]

Abstract: Background: Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. Methods: The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) timeto healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reportedpain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG);measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and presence or absence of underlying systemic disease (for example, rheumatoid arthritis).Patients who require topical therapy are asked to enter a parallel observational study (case series). If topical therapy fails and systemic therapy is required, participants are then considered for inclusion in the randomised trial.Trial registration: Current controlled trials: ISRCTN35898459. Eudract No.2008-008291-14. [ABSTRACT FROM AUTHOR]

Background: Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description: The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011) covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each trial, the database gives the citation for the published report and also provides enough information to enable a user to decide whether the trial is worth further scrutiny. Conclusions: The Global Resource of Eczema Trials has been created to facilitate knowledge mobilization into healthcare and to reduce wastage of research time through unnecessary duplication. The collective time saved by research groups around the world can now be used to make strides in optimising the treatment of eczema, in order to further benefit people with eczema. The database can be accessed free of charge at http://www.greatdatabase.org.uk [ABSTRACT FROM AUTHOR]

In the course of producing the 2009 NHS Evidence - skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of trial reporting were identified. Several trials concluded no effect of a treatment yet they were insufficiently powered to exclude potentially useful benefits. There were examples of duplicate publication and "salami publication", as well as two trials being combined and reported as one. In some cases, an incorrect "within-groups" statistical comparison was made and one trial report omitted original efficacy data and included only P values. Both of the non-inferiority studies examined failed to pre-specify a non-inferiority margin. Trials reported as "double-blind" compared treatments that were dissimilar in appearance or had differing adverse effect profiles. In one case an intention-to-treat analysis was not performed and there was a failure to account for all of the randomized participants. Trial results were made to sound more impressive by selective outcome reporting, emphasizing the statistical significance of treatment effects that were clinically insignificant, and by the use of larger-sounding odds ratios rather than rate ratios for common events. Most of the reporting problems could have been avoided by use of the CONSORT guidelines and prospective trial registration on a public clinical trials database. [ABSTRACT FROM AUTHOR]

Antibiotics are among the most important interventions in healthcare. Resistance of bacteria to antibiotics threatens the effectiveness of treatment. Systematic reviews of antibiotic treatments often do not address resistance to antibiotics even when data are available in the original studies. This omission creates a skewed view, which emphasizes short-term efficacy and ignores the long-term consequences to the patient and other people. We offer a framework for addressing antibiotic resistance in systematic reviews. We suggest that the data on background resistance in the original trials should be reported and taken into account when interpreting results. Data on emergence of resistance (whether in the body reservoirs or in the bacteria causing infection) are important outcomes. Emergence of resistance should be taken into account when interpreting the evidence on antibiotic treatment in randomized controlled trials or systematic reviews. [ABSTRACT FROM AUTHOR]

Background: Valid and reliable outcome measurements are a prerequisite for evidence-based practice. The comparative validity and reliability of outcome measurements for assessing atopic eczema (AE) severity is unclear. Objective: We sought to assess the validity, reliability, sensitivity to change, and ease of use of outcome measurements for AE. We also sought to give recommendations on which outcomes to use in clinical research and for clinical monitoring. Methods: We performed a systematic review and survey of clinical experts and patients. Results: Twenty published outcome measurements were identified. There is evidence of adequate construct validity for 3 measurements (Severity Scoring of Atopic Dermatitis index [SCORAD], Eczema Area and Severity Index [EASI], and Three Item Severity Score), adequate internal consistency of 1 scale (Patient-oriented Eczema Measure [POEM]), adequate interobserver reliability of 5 measurements (Basic Clinical Scoring System; Nottingham Eczema Severity Score; Objective Severity Assessment of Atopic Dermatitis; Six Area, Six Sign Atopic Dermatitis severity score; and SCORAD), adequate test-retest reliability of 1 scale (POEM), and adequate sensitivity to change of 3 measurements (EASI, SCORAD, and Investigators'' Global Atopic Dermatitis Assessment). Most outcome measurements have adequate content validity, as assessed by patients and experts. Data on the time to perform the assessment was identified for 8 outcome measurements. Only SCORAD, EASI, and POEM have been tested sufficiently and performed adequately. Conclusion: There are too many published outcome measures for AE. Most have not been tested properly or perform adequately when tested, and their continued use hampers scientific communication. Clinical implications: Only SCORAD, EASI, and POEM currently perform adequately. These scales should be used in future studies. [Copyright &y& Elsevier]

When discussing treatment options with patients, clinicians often use terms such as “frequently” or “rarely” when referring to potential benefits or possible harms. Quantitative measurements of treatment benefits and harms derived from randomized clinical trials or meta-analysis such as odds ratios or risk reduction are more precise terms, yet physicians and their patients find them difficult to understand and they are not, therefore, commonly used in clinical practice. To overcome the lack of intuitiveness for traditional measures of risk estimates derived from clinical trials, the number needed to treat (NNT) has been widely recommended as a measure of effectiveness, and number needed to harm as a way of describing risk of possible adverse events. NNT is simply the number of patients who, on average, would need to be treated with a proposed intervention to demonstrate one additional gain over the standard comparator intervention. NNT is an absolute measure and it is calculated as the inverse of the absolute risk reduction. In this article we describe the usefulness and limits of the NNT with particular reference to dermatology, and compare NNT with other relative measures such as the relative risk and relative risk reduction. [Copyright &y& Elsevier]

The article provides information on the scientific concepts underlying pragmatic clinical trials in dermatology. It discusses the objectives of pragmatic clinical trials and its comparison to explanatory clinical trials, limitations of pragmatic clinical trials, and the use of the Pragmatic-Explanatory Continuum Indicator Summary tool.

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it. [ABSTRACT FROM AUTHOR]

The article reports that the International Committee of Medical Journal Editors (ICMJE) is a group of the world's leading medical journals whose participants meet annually to improve standards in manuscripts submitted to biomedical journals. In September 2004, the ICMJE announced a tough new stance on registering clinical trials. All trials that start enrolling participants after July 1, 2005 must register their trial in a suitable publicly accessible register before that date in order to be considered for subsequent publication in those journals.

Background: Pyoderma gangrenosum is a rare inflammatory skin condition. Two prospective studies have evaluated treatments for pyoderma gangrenosum using a primary outcome of healing speed at 6 weeks.Objective: Using data from both studies we assessed the predictive value of 3 early predictors for healing at 6 months: speed of healing, Investigator Global Assessment (IGA), and resolution of inflammation, recorded at 2 and 6 weeks.Methods: Logistic regression models were applied and the effectiveness of the 3 measures was assessed through estimating the positive and negative predictive values and the area under the receiver operating characteristic curve.Results: The positive and negative predictive value at 6 weeks were, respectively, 63.5% (95% confidence interval [CI] 52.4%-73.7%) and 74.6% (95% CI 62.5%-84.5%) for speed of healing; 80% (95% CI 68.7%-88.6%) and 74.2% (95% CI 64.1%-82.7%) for IGA; and 72.1% (95% CI 59.9%-82.3%) and 68.1% (95% CI 57.7%-77.3%) for resolution of inflammation. IGA had the best combined positive predictive value, negative predictive value, and area under the receiver operating characteristic curve at 2 and 6 weeks.Limitations: We were limited by data available from existing datasets.Conclusion: Speed of healing, IGA, and resolution of inflammation were all shown to be good predictors of eventual healing of pyoderma gangrenosum. [ABSTRACT FROM AUTHOR]

Comments on the study on the use of fluticasone propionate added to emollient maintenance treatment to reduce the risk of relapse in atopic dermatitis (AD). Short duration of most clinical trials for the treatment of AD; Relapse of the disease over a 16-week period; Quality of the study; Side effects; Effectiveness of fluticasone.

Comments on the research 'A Double-blind, Randomized, Controlled Clinical Trial to Assess the Efficacy of a New Coal Tar Preparation (Exorex) in the Treatment of Chronic, Plaque-type Psoriasis.' Topical formulation for the treatment of psoriasis; Failure of the study to show a clinically important difference in efficacy between the Exorex and coal tar-control treated sides at the end of the evaluation period.