Atopic Dermatitis (AD) Case Study

Click here for a PDF version of this case study

Outcomes

Innovaderm successfully managed this AD study
and this resulted in:

Enrollment completed 2 months earlier than planned;
Innovaderm CRU recruited 33% of patients

Study Characteristics

- Study Phase: Ib

Patient Population: 36 subjects with moderate to severe AD
IP Route of Administration: Systemic - Oral
Site distribution: 10 sites in 2 countries (USA and Canada)
Study Design: Randomized, sequential, placebo-controlled, double-blind | Multiple ascending dose (MAD): 3 sequential cohorts
Study procedures: 4.5 mm punch skin biopsies, photographs, biomarker analysis, skin microbiome, pharmacokinetics, tape stripping and efficacy-safety assessments

Study Challenges

- Recruitment during summer months; Seasonality impacts on AD flares
- Short treatment duration; 4-week treatment period
- Data and Safety Monitoring Board (DSMB) after each cohort; Challenging to manage without affecting recruitment

Key Success Factors & Strategies

Recruitment completed in 6 months vs planned 8 months

Outstanding contribution by Innovaderm's Clinical Research Unit

Recruitment Curve

Enrollment target reached 2 months ahead of schedule

Newsletter

Get notified to have the latest trends and be at the forefront of dermatology clinical research and innovation.

Newsletter subscription resources

*By subscribing to our newsletter, you acknowledge and agree to the terms of our privacy policy.

Blog Article

The Role of Skin barrier Dysfunction in Atopic Dermatitis—The Microbiome

Table of contents Cutaneous Dysbiosis Interplay S. aureus: Its Interaction and Impact on Skin S. aureus and Inflammation Focusing on the microbiome, Staphylococcus aureus (S. aureus) is a widespread bacterium that produces a multilayer biofilm, was shown to colonize the skin and play a critical role in Atopic Dermatitis (AD). Over 70% of people are […]

Blog Article

Enhancing Clinical Performance and Cost Efficiency: The Significance of Protocol Writing in Dermatology Trials

Did you know that protocol amendments are not only common, but also very costly? In fact, as per a recent article by Getz K. et al., 57% of protocols had at least one substantial amendment with an average of 2.3 global amendments for phase 2 and phase 3 studies. The cost to implement one protocol amendment was $141,000 US for a phase 2 study and $535,000 US for a phase 3 study. To avoid unnecessary hassle and expenses, take the time to ensure your protocols are well written and top-notch quality.

Blog Article

How to Write First-Rate Protocols for a Psoriasis Study - Focus: Study Design

The success of any clinical study is dependent upon a sturdy protocol; the overall quality of the study depends on this very document. This is especially true for multicenter studies which involve many investigators and clinical staff. This article will explore the best tips to deliver first-rate protocols in psoriasis to set you apart from the competition. Innovaderm Research Inc specializes in a spectrum of dermatological indications, namely acne vulgaris, atopic dermatitis, and psoriasis.