Dermatological conditions can cause patients physical, mental, and emotional distress. We believe that everyone should be able to feel comfortable in their own skin. Having supported more than 175 dermatology clinical trials, Rho is recognized as an industry leading CRO in the space. Serving as the statistical and clinical coordinating center for the NIAID funded Atopic Dermatitis Research Network (ADRN) since 2004, we fully understand the challenges prevalent in today’s dermatology landscape. While we are able to support a variety of indication-specific studies, we have a strong history with atopic dermatitis, alopecia areata, pruritus, and vitiligo trials. Our regulatory, biometrics, and government partnership expertise compliments our deep understanding of skin conditions to create a unique approach.

Why Choose Rho?

The race to market for dermatology products, especially for atopic dermatitis and alopecia areata treatments and therapies, makes efficient start up timelines more important than ever. Increasing operational efficiencies, and leveraging site and PI relationships that cross multiple indications and sponsors, are critical to advancing a program. We keep your goal on top of mind — from study conduct to applications submission, through collaborative and strategic planning between operational and regulatory teams and the sponsor. Our cross-functional approach allows us to identify challenges early and eliminate the missteps and delays often caused by silos and handoffs. Rho’s collective regulatory experience in dermatology development programs and working with FDA CDER Division of Dermatology & Dentistry and Office of Therapeutic Products (OTP) spans a broad range of products and indications.

Expertise in Action

• Long standing relationships with sites, KOLs, SMOs (site management organizations), and Patient Advocacy Groups (e.g., National Eczema Association, NAAF, Bald Girls Do Lunch)
• Collective regulatory experience in dermatology development programs and working with FDA CDER Division of Dermatology & Dentistry and Office of Therapeutic Products (OTP) spans a broad range of products and indications
• Recent extensive regulatory, biometrics, and authoring support for 6 global marketing applications including 4 NDAs to FDA Division of Dermatology & Dentistry
• Support of multiple dermatology development programs, including pre-IND activities, IND preparation/maintenance, and marketing applications
• Strong understanding of patient populations, assessments and patient reported outcomes

Atopic Dermatitis

• Managed 30+ clinical trials in atopic dermatitis, including registry and Phase 1-3 studies
• Serve as the Statistical and Clinical Coordinating Center for the NIAID-funded Atopic Dermatitis Research Network since 2004
• Strong knowledge of patient populations and experience in developing inclusion and exclusion criteria, including required medication washouts
• Experience with biopsies and tape strips
• Extensive expertise in Assessments and Patient Reported Outcomes specific to atopic dermatitis
  • DQLI, EASI, IGA, POEM, Pruritus NRS, SCORAD
  • Skin prick testing
• Statistical analysis of biomarker data

Alopecia Areata

• Managed numerous Phase 1-3 alopecia areata trials for multiple sponsors spanning 100+ sites and 1000+ patients
  • In an 8 year partnership with one client,
    • we successfully guided the sponsor through 3 Phase 2 studies
    • helped the sponsor expand their Phase 2 development program into a global Phase 3 program by providing a centralized, global model
    • supported the client with their NDA submission and subsequently expanded into a new dermatology indication with the same drug
• Led a North American based Phase 2 alopecia areata study which led to a subsequent global atopic dermatitis study with the same sponsor
• Strong understanding of Assessments and Patient Reported Outcomes specific to alopecia areata
  • SALT, SPRO, BETA, BELA, QPRO
  • Photography of hair and skin, skin prick testing and wheal measurements, allergen skin testing

Patient Reported Outcomes

• DLQI, POEM, Pruritus Numeric Rating Scale (PNRS) 
• Skin Pain Numerical Rating Scale (SP-NRS) 
• Patient Global Impression of Severity for AD (PaGIS-AD) 
• Patient Global Impression of Change for AD (PaGIC-AD) 
• Patient Global Impression of Bother for AD (PaGIB-AD) 
• Subject Satisfaction Questionnaire (SSQ) 
• Subject Satisfaction Rating Scale (SSRS) 
• SCORAD (VAS portion)
• EASI, vIGA-AD, Hand Dermatitis Investigator Global Assessment (IGA), SCORAD

Decentralized Trial Solutions 

At Rho, we believe that the best decentralized solutions are patient-centric, customizable, and rooted in a robust Risk-Based Quality Management (RBQM) framework. With patient safety and patient centricity as our primary goal, we use our data-driven RBQM process to evaluate risk and make recommendations for the optimal decentralized solution for your clinical trial or program. When designing and executing decentralized solutions, our teams focus on ensuring patient safety, increasing patient engagement, and reducing patient burden. We have found decentralized solutions essential in successful dermatology clinical trials. Prioritizing the patient’s comfort is of the utmost importance during dermatology studies, and our decentralized approach ensures positive patient experience and study outcomes.