Atopic Dermatitis, Psoriasis & Inflammatory Skin Disease
A comprehensive analysis of the dermatology clinical trial landscape — from validated scoring systems and photographic documentation to biologic-experienced populations and pipeline dynamics across JAK inhibitors, IL-targeted therapies, and novel topical agents.
The Dermatology Trial Landscape in 2026
Dermatology has emerged as one of the most dynamic therapeutic areas in clinical development, driven by a wave of biologic innovation and a deepening understanding of the immunological mechanisms underlying chronic inflammatory skin disease. Within the Clinitiative network, dermatology represents a rapidly growing portfolio with 18 active studies spanning atopic dermatitis (AD), plaque psoriasis, pustular psoriasis, palmoplantar psoriasis, acne vulgaris, alopecia areata, hidradenitis suppurativa (HS), and vitiligo. This breadth reflects both the high prevalence of skin disease globally and the extraordinary volume of novel therapeutics entering clinical evaluation across multiple mechanisms of action.
Moderate-to-severe atopic dermatitis is the single largest indication in our dermatology portfolio, accounting for 7 of the 18 active protocols. The AD landscape has been fundamentally reshaped by the success of dupilumab and the subsequent approval of JAK inhibitors, creating a highly competitive therapeutic environment where new entrants must demonstrate differentiation on efficacy, speed of onset, durability, and safety profile. Psoriasis follows with 5 active studies, predominantly in moderate-to-severe plaque disease but with increasing attention to difficult-to-treat subtypes including pustular and palmoplantar variants. The remaining 6 studies are distributed across alopecia areata, HS, vitiligo, and moderate-to-severe acne — indications that have historically been underserved by clinical research but are now attracting significant pipeline investment.
The dermatology trial landscape is evolving rapidly as JAK inhibitors and interleukin-targeted biologics — particularly those directed against IL-13, IL-31, and IL-36 — continue to reshape treatment paradigms. Novel topical agents including topical JAK inhibitors, tapinarof, and roflumilast are expanding the therapeutic toolkit for mild-to-moderate disease, creating new clinical trial opportunities in patient populations that were previously difficult to study in controlled settings. This convergence of systemic and topical innovation is driving unprecedented trial volume and complexity across the dermatology spectrum.
Key Performance Metrics
Network-wide benchmarks from our dermatology portfolio provide critical reference points for study planning and site performance evaluation across inflammatory skin disease indications.
Dermatology benefits from high disease prevalence, enabling strong enrollment velocity across the network. Atopic dermatitis studies consistently lead at 3.2 patients per site per month, driven by large patient pools in allergy and dermatology referral networks. Psoriasis studies average 2.6 patients per site per month, with plaque psoriasis outpacing pustular and palmoplantar subtypes. Alopecia areata and HS studies trend lower at 1.8-2.0 per site per month due to more restrictive eligibility criteria and smaller addressable populations.
Screen failure rates in dermatology are driven primarily by disease severity scoring thresholds. Studies requiring EASI scores above 16 or PASI scores above 12 for enrollment account for the majority of screen failures, as patients presenting during mild flare periods may not meet minimum severity cutoffs at the screening visit. Washout-related failures represent an additional 12% of all screen failures, occurring when patients are unable or unwilling to discontinue current effective therapies for the required washout duration prior to baseline assessment.
Dermatology studies consistently achieve faster site startup timelines compared to most therapeutic areas, reflecting lower regulatory complexity, fewer specialized infrastructure requirements, and well-established IRB pathways for inflammatory skin disease research. Sites with existing dermatology scoring certification and photography infrastructure achieve startup 2-3 weeks faster than sites requiring de novo rater training and photography suite configuration prior to first patient screening.
Patient retention in dermatology studies is supported by the visible nature of treatment response, which provides patients with tangible evidence of benefit that reinforces study adherence. Biologic and oral systemic studies achieve retention rates of 88-91%, while topical vehicle-controlled studies in mild-to-moderate disease experience higher attrition at 78-82%, driven by patient frustration with vehicle-only arms and the availability of effective over-the-counter alternatives outside the study context.
Network Capabilities
Executing dermatology trials at the quality and consistency required by modern protocols demands specialized infrastructure, trained personnel, and standardized operational processes. Our network has been developed to ensure deep dermatology-specific capabilities across every participating site, from validated scoring expertise to photographic documentation and tissue biomarker analysis.
Validated Dermatology Scoring
Accurate and consistent disease severity assessment is the foundation of dermatology trial execution. Our network investigators and sub-investigators are trained and certified in all major dermatology scoring instruments including the Eczema Area and Severity Index (EASI), Psoriasis Area and Severity Index (PASI), Investigator Global Assessment (IGA), Scoring Atopic Dermatitis (SCORAD), and the Hidradenitis Suppurativa Clinical Response (HiSCR) scoring system. All raters undergo initial certification training with photographic case exercises and participate in ongoing inter-rater calibration sessions conducted quarterly to minimize scoring drift and ensure consistency across sites and timepoints.
For studies requiring centralized scoring adjudication, our sites maintain standardized documentation workflows that support remote review by central raters, including structured body region mapping, lesion counting protocols, and severity component scoring that aligns with sponsor-specific scoring manuals. Sites with established rater calibration programs demonstrate 35% fewer scoring queries compared to sites without formal inter-rater reliability processes.
Photographic Documentation & Central Review
Standardized clinical photography is increasingly required in dermatology protocols as both a primary and secondary efficacy endpoint and as a quality assurance measure for scoring validation. Our network sites maintain dedicated photography suites equipped with controlled lighting environments, standardized patient positioning guides, calibrated color reference cards, and high-resolution digital camera systems configured to sponsor specifications. VISIA complexion analysis imaging is available at select sites for studies requiring quantitative assessment of pigmentation, texture, and vascular changes — particularly relevant in vitiligo and acne programs.
All photographic data is captured using standardized protocols that ensure consistent framing, lighting angle, and resolution across visits, enabling reliable longitudinal comparison and central review adjudication. Sites with established photography workflows achieve 95% first-pass acceptance rates from central imaging vendors, reducing re-photography requirements that can delay data cleaning and database lock timelines.
Skin Biopsy & Histopathology
An increasing number of dermatology protocols include skin biopsy as part of the study assessments, whether for histopathologic confirmation of diagnosis, pharmacodynamic biomarker evaluation, or translational research endpoints. Our network sites are equipped for punch biopsy procedures with standardized collection, processing, and shipping protocols for both formalin-fixed paraffin-embedded (FFPE) and fresh-frozen tissue specimens. Established relationships with dermatopathology laboratories enable rapid turnaround for diagnostic confirmation, while biomarker tissue banking capabilities support long-term specimen storage for future translational analyses.
For studies requiring immunohistochemistry, gene expression profiling, or spatial transcriptomics on skin biopsy specimens, our sites follow sponsor-specific tissue handling protocols that preserve analyte integrity from collection through shipment. Biopsy-related screen failures are minimized through pre-biopsy clinical assessment workflows that confirm disease eligibility criteria before subjecting patients to invasive procedures.
Patient-Reported Outcome Infrastructure
Dermatology trials rely heavily on patient-reported outcomes (PROs) to capture the subjective disease burden that clinical scoring alone cannot quantify. Our network sites are equipped with electronic PRO (ePRO) capture systems that support validated instruments including the Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), itch Numerical Rating Scale (NRS), sleep disturbance NRS, and disease-specific quality-of-life measures. ePRO platforms are configured for both in-clinic completion and remote daily diary capture, enabling real-time symptom monitoring between study visits.
Compliance rates for ePRO completion across the network average 92%, supported by automated reminder systems, coordinator follow-up protocols for missed entries, and patient training sessions conducted at enrollment that familiarize participants with the ePRO devices and completion expectations. High PRO compliance is essential for dermatology endpoints, as missing PRO data at key timepoints can compromise the statistical analysis of co-primary and key secondary endpoints that increasingly rely on patient-reported measures.
Enrollment Dynamics
Dermatology enrollment patterns are shaped by unique factors including high disease prevalence, seasonal variability, treatment history requirements, and competitive dynamics among an increasingly crowded therapeutic landscape. Understanding these dynamics is critical for realistic enrollment planning and site management across inflammatory skin disease indications.
Large patient pools across atopic dermatitis, psoriasis, and acne provide a strong foundation for enrollment, but competition for specific patient subpopulations — particularly biologic-naive patients with moderate-to-severe AD — has intensified significantly as the number of active studies has grown. The widespread availability of dupilumab, tralokinumab, and JAK inhibitors means that an increasing proportion of patients with moderate-to-severe disease have prior biologic or advanced therapy exposure, making it progressively more difficult to identify and enroll biologic-naive populations that many Phase III protocols still require or preferentially target.
Washout requirements represent a significant enrollment barrier in dermatology trials. Patients on effective systemic therapies are often reluctant to discontinue treatment and endure disease flare during the washout period, particularly when the washout duration extends to 4-12 weeks depending on the prior therapy. Our network addresses this challenge through patient education programs that set clear expectations about the washout process, rescue medication protocols that provide safety nets for severe flares, and flexible screening scheduling that allows patients to initiate washout at times that minimize impact on work and daily life.
Seasonal disease severity variability, particularly in atopic dermatitis, introduces an additional layer of complexity to enrollment planning. AD severity tends to worsen in winter months due to low humidity and indoor heating, creating natural enrollment peaks between October and March when more patients meet minimum severity thresholds. Conversely, summer months may see reduced screening volumes as UV exposure and higher humidity improve skin barrier function. Our network leverages dermatology referral networks, allergy clinic partnerships, and patient registry databases to maintain enrollment continuity across seasonal fluctuations, with targeted outreach campaigns timed to coincide with anticipated disease flare periods.
Key Challenges in Dermatology Trial Execution
The evolving complexity of dermatology protocols and the competitive enrollment landscape present operational challenges that require specialized strategies and infrastructure.
Biologic-Experienced vs Biologic-Naive Requirements
The increasing difficulty of identifying biologic-naive patients with moderate-to-severe atopic dermatitis represents the most significant enrollment challenge in the dermatology space. As approved biologic and JAK inhibitor therapies become standard of care, the pool of treatment-naive patients with severe disease continues to shrink. Protocols requiring biologic-naive populations now experience enrollment timelines 40-60% longer than those accepting biologic-experienced patients. Our network addresses this through early patient identification in primary care and allergy settings before specialist referral and advanced therapy initiation, partnerships with pediatric-to-adult transition clinics where patients may not yet have received biologics, and database screening across health system electronic medical records to identify eligible patients who have not yet been prescribed advanced therapies.
Scoring Consistency & Rater Training
Inter-rater variability in dermatology severity scoring instruments remains a persistent challenge that can introduce noise into efficacy endpoints and compromise data quality. EASI and PASI scoring require subjective assessment of erythema, induration, excoriation, and lichenification across multiple body regions, and studies have demonstrated that untrained raters can differ by 20-30% in total EASI scores for the same patient. Our network mitigates this risk through mandatory rater certification programs with photographic case validation, quarterly inter-rater calibration exercises using standardized patient vignettes, centralized scoring review for outlier detection, and real-time rater feedback loops that identify and correct scoring drift before it impacts study data. Sites participating in our calibration program achieve intra-class correlation coefficients exceeding 0.85 for EASI scoring.
Washout Period Compliance
Patients enrolled in dermatology trials frequently struggle with the washout period required to eliminate the pharmacological effects of prior therapies before baseline assessment. The clinical reality is that patients have sought effective treatment precisely because their disease is burdensome, and asking them to discontinue therapy — even temporarily — creates genuine hardship and disease flare that can lead to screening withdrawal. Washout-related screen failures account for approximately 12% of all screen failures across our dermatology portfolio. Our network supports washout compliance through detailed patient counseling at the pre-screening stage, provision of approved rescue medications for intolerable flare, flexible scheduling that allows washout timing to align with patient preferences, and coordinator check-in calls during the washout period to address concerns and maintain engagement.
Placebo Response in Dermatology
Vehicle-controlled studies in mild-to-moderate dermatology indications consistently demonstrate higher-than-expected placebo response rates, which can compromise the ability to demonstrate treatment differentiation and statistical significance. In topical vehicle studies for mild-to-moderate AD and psoriasis, placebo response rates of 15-25% are common, driven by the emollient effects of the vehicle formulation, increased skin care attention during study participation, and the natural waxing and waning disease course. Our network addresses placebo response through rigorous baseline disease severity confirmation at multiple timepoints, patient education about the importance of maintaining consistent skin care routines, and study design consultation that recommends appropriate run-in periods and minimum disease severity thresholds to reduce the impact of placebo response on treatment effect estimation.
Pipeline Analysis
The dermatology development pipeline continues to expand with remarkable breadth, spanning multiple mechanisms of action, routes of administration, and disease indications. Several key therapeutic trends are driving shifts in trial design, site requirements, and enrollment strategy across the inflammatory skin disease landscape.
Next-Generation IL-Targeted Biologics
The next wave of biologic therapies for inflammatory skin disease targets specific interleukin pathways with increasing precision. IL-13-specific antibodies are advancing through late-phase development for AD, aiming to demonstrate differentiation from dual IL-4/IL-13 blockade through improved tolerability profiles. IL-31 receptor antagonists target the neuroimmune itch pathway directly, offering a novel approach to the most burdensome symptom in AD. IL-36 receptor antagonists are transforming the treatment of pustular psoriasis, a severe and previously underserved indication. OX40 and OX40L-targeted agents represent an emerging mechanism that modulates T-cell co-stimulation in AD and other T-cell-mediated skin diseases. These biologic programs require sites with subcutaneous and intravenous administration capabilities, immunogenicity sample processing, and long-term safety monitoring infrastructure.
Oral JAK Inhibitors & Small Molecules
Oral JAK inhibitors have established a new treatment paradigm in dermatology, offering rapid onset of action and convenient oral dosing for moderate-to-severe inflammatory skin disease. Selective JAK1 inhibitors continue to advance in AD, alopecia areata, and vitiligo, while TYK2 inhibitors represent a potentially safer alternative with selectivity away from JAK2 and JAK3. PDE4 inhibitors provide another oral small molecule option with a differentiated safety profile. These programs require sites to implement enhanced cardiovascular and thromboembolic safety monitoring, regular laboratory assessments including lipid panels and complete blood counts, and long-term follow-up protocols that address the evolving regulatory requirements for JAK inhibitor safety surveillance — particularly in dermatology populations that tend to be younger and healthier than the rheumatology populations where safety signals were initially identified.
Topical Innovation
The topical therapeutic landscape is undergoing a renaissance with the emergence of novel mechanisms that move beyond traditional corticosteroids and calcineurin inhibitors. Topical JAK inhibitors such as ruxolitinib cream have demonstrated efficacy in AD and vitiligo with minimal systemic exposure, opening opportunities for long-term maintenance therapy in mild-to-moderate disease. Tapinarof, an aryl hydrocarbon receptor modulating agent, represents an entirely new mechanism for psoriasis and AD. Topical PDE4 inhibitors including roflumilast cream are expanding treatment options for plaque psoriasis in sensitive skin areas. These topical innovation programs present unique trial execution requirements including standardized application area mapping, compliance monitoring through tube weight measurement, and vehicle-controlled study designs that demand rigorous blinding and patient management to minimize differential dropout.
Emerging Indications
Several dermatology indications that have historically lacked effective treatments are now attracting significant pipeline investment. Alopecia areata has emerged as a major focus following the approval of baricitinib, with multiple JAK inhibitors and other mechanisms in development. Vitiligo is seeing its first wave of targeted therapies, predominantly topical JAK inhibitors and emerging systemic agents. HS remains severely underserved despite its debilitating impact, with biologic programs targeting IL-17, TNF, and novel pathways advancing through clinical development. Prurigo nodularis, a chronic itch condition with profound quality-of-life impact, is gaining pipeline attention through IL-31 and other neuroimmune targets. These emerging indications require sites to develop indication-specific expertise in disease assessment, patient identification, and long-term management, as many of these conditions involve patient populations with limited prior clinical trial exposure and unique psychosocial considerations.
Site Requirements for Dermatology Excellence
The infrastructure, staffing, and operational processes required to execute modern dermatology protocols at the highest level of quality and consistency.
Dedicated examination rooms equipped for full-body skin assessment, calibrated lighting for accurate erythema and pigmentation evaluation, standardized body surface area mapping tools, and access to validated scoring training materials. Rater certification records and inter-rater calibration documentation maintained for audit readiness.
Controlled-environment photography room with standardized lighting, patient positioning guides, calibrated color reference standards, and high-resolution digital imaging systems. VISIA or equivalent complexion analysis capability for studies requiring quantitative photographic assessment. Secure image transfer and archival systems compliant with sponsor and central review vendor specifications.
Punch biopsy capability with sterile procedure rooms, standardized specimen collection and processing kits for FFPE and fresh-frozen tissue, established dermatopathology laboratory relationships for diagnostic confirmation, and biomarker tissue banking infrastructure for translational research specimen storage and future analysis.
Electronic PRO platforms configured for DLQI, POEM, itch NRS, sleep NRS, and disease-specific quality-of-life instruments. Support for in-clinic and remote daily diary capture with automated compliance monitoring, reminder systems, and coordinator alert workflows for missed entries. Device provisioning and patient training protocols at enrollment.
Research pharmacy with temperature-controlled storage for biologic investigational products, topical formulation management including tube weight documentation for compliance monitoring, drug accountability systems, and dispensing protocols for both systemic and topical investigational agents. Blinding maintenance for vehicle-controlled topical studies.
Board-certified dermatologist investigators with clinical trial experience, certified clinical research coordinators trained in dermatology scoring and photographic documentation, ePRO support staff, research nurses capable of subcutaneous and intravenous biologic administration, and regulatory coordinators managing IRB submissions and protocol amendments.
Discuss Your Dermatology Program
Connect with our team to explore site capabilities, enrollment strategies, and scoring infrastructure for your dermatology clinical development program.