Advanced dermatology protocols require more than just standard site execution; they demand precise data and response-guided care. As clinical pipelines increasingly prioritize complex immunological conditions like Hidradenitis Suppurativa (HS), DelRicht Research distinguishes itself as a high-speed partner for sponsors and CROs. By pairing data-driven recruitment with agile infrastructure, our network mitigates screening challenges and delivers robust data necessary to advance complex skin therapies.

DelRicht Research deployed a powerhouse network of three high-performing sites. The 44-week trial targeted a complex patient population: adults aged 18 to 70 with at least a 6-month history of HS, lesions in two or more distinct anatomical areas (with at least one area meeting Hurley Stage II or III criteria), and a total abscess and inflammatory nodule (AN) count of five or more. Additionally, candidates must have demonstrated an inadequate response, intolerance, or contraindication to oral antibiotics.

Exceeding Enrollment Targets & Investigator Expertise

The global metrics for this study planned to enroll 225 patients across 58 sites. Initially, DelRicht planned to enroll 11.7 patients across 3 sites, but instead enrolled 27 patients across 3 sites, achieving 232.7% of target enrollment. This enrollment success earned our 3 sites top enroller status studywide with Dr. Ira Thorla highlighted for First Site Activation and First Patient First Screened Studywide. Marshall Morris, Partner at DelRicht Research commented:

“Achieving 232% of our enrollment goal across three distinct sites demonstrates the power of a disciplined, patient-centric approach to clinical research. Our investigators and site managers consistently prove that when you combine strategic profile screening with flawless site execution, you can drastically collapse traditional enrollment timelines for critical Phase 2 programs.”

 

– Marshall Morris, Partner at DelRicht Research

Our network success is anchored by a roster of experienced Principal Investigators (PIs) and dedicated site leadership who specialize in the complexities of advanced dermatological trials:

– Dr. Christie Matter at Lockhart Matter Dermatology | Dallas, TX
– Dr. Ira Thorla at LA Dermatology Associates | Baton Rouge, LA
– Dr. Stephanie Smith-Phillips at Mt. Pleasant Dermatology | Mt. Pleasant, SC

Overcoming Key Challenges

Large-scale dermatology trials present unique hurdles that can threaten both the enrollment timeline and the quality of the clinical data collected. DelRicht identified two key operational challenges that any site running this protocol would face and implemented systematic solutions to mitigate them.

Fluctuation in Lesion Profile Screening

Due to natural fluctuations in Hidradenitis Suppurativa disease severity, some patients experienced symptom regression that placed them below eligibility thresholds at screening. To overcome this, our teams monitored disease activity trends among potential participants prior to screening and leveraged protocol-allowable scheduling flexibility when appropriate. By aligning screening visits with periods of higher disease activity, the team reduced screen failures, optimized enrollment, and minimized unnecessary patient travel.

Subjectivity in Data Quality and Lesion Evaluation

The accuracy of abscess and inflammatory nodule counts relied heavily on investigator assessment. Because these physical examinations are inherently subjective and depend closely on the fluctuating severity of the disease, high inter-rater variability could threaten the robustness of the primary endpoint data. Our site teams were able to optimize data quality and sharply reduced assessment variance by implementing a three-tiered rater protocol:

– Rater Calibration: Thorough internal team training sessions aligned all clinical eyes on lesion identification.
– Rater Consistency: The exact same investigator/evaluator was utilized across a single participant’s subsequent visits to eliminate inter-rater variance.
– Cross-Referencing: Raters consistently cross-referenced historical data of prior lesion counts to track precise disease progression.

What This Means for Sponsors and CROs

This performance reinforces the competitive advantages of partnering with a fully aligned site network for complex immunological research: rapid start-up, enrollment velocity, and data integrity. Rapid start-up timelines can significantly accelerate overall study progress and achievements like FSA and FPFV, ensuring that your study hits the ground running. By navigating restrictive eligibility criteria and disease fluctuations at the site level, we maintain high enrollment without compromising protocol compliance. These capabilities paired with our implementation of active rater calibration and consistent evaluator assignments ensure highly reliable data sets for primary endpoint analysis.

Partner With DelRicht Research

From rapid startup to high-performance patient enrollment, DelRicht Research delivers the infrastructure, investigator expertise, and data management required for modern Phase 2 and Phase 3 dermatological trials. If you are planning an upcoming immunology or dermatology program, our team is ready to accelerate your timelines and exceed your enrollment targets.

Learn more at www.DelRichtResearch.com or connect with our business development team to discuss your next clinical protocol.