Dermatology is a unique and often complex therapeutic area for conducting clinical research, which is why it is crucial to select a CRO with ample experience in dermatology research to manage your study.
ethica CRO is highly experienced in the following areas:
Psoriasis, atopic dermatitis, seborrheic dermatitis, etc.
fillers, botulinum toxin, topical retinoids, laser/light treatments, etc.
Do you want to learn more about how our clinical expertise can benefit your dermatological study ?
Dermatological studies often face a number of challenges throughout their lifecycles. In order to become accepted by regulatory agencies, many endpoints based on qualitative and subjective assessment scales will require robust validation. Additionally, it is often the case that environmental and seasonal factors confound study results and affect research participant recruitment as well as study compliance.
Several study designs also employ novel assessment tools and may require specialized services such as photography or dermopathology in order to achieve their primary study outcome.
Our Dermatology Expertise
When it comes to your dermatology research program, we are eager to provide insight and strategic guidance to ensure that your study offers optimal research participant experience and viable clinical outcomes. Our dedicated team of clinical experts will effectively design and manage your drug, device, or cosmetic study.
At ethica CRO, not only do we understand the challenges of dermatological research, but we also know how to effectively leverage these obstacles within your clinical study’s design and logistics. Whatever hurdle you may come across during your research program, ethica CRO has the right tools and experience to ensure your study’s success.
Since its inception, ethica CRO has completed over 170 dermatology studies.
Your CRO of Choice for Dermatology Clinical Research
Our team will help you:
- Appropriately validate your assessment scales;
- Manage research participant screening and education;
- Promote compliance and retention, especially when dealing with a younger demographic.
Case Study – FDA’s First Approval of a Dermal Filler for the Treatment of Acne Scars: How ethica CRO helped its client meeting unique technical challenges
It is estimated that between 40 and 50 million people in the U.S. currently suffer from acne. Approximately 95% of acne patients are affected by permanent textural changes, scarring, and skin indentations that occur as a result of acne. Acne scarring, whether it is moderate or severe, can significantly impact the well-being and quality of life of acne patients.
ethica CRO successfully designed and managed a double-blinded, randomized, placebo-controlled pivotal study that led to the FDA’s first approval of a dermal filler for the treatment of acne scars.
Designing and managing filler studies for nasolabial folds, lip augmentation or cheek volumization is quite straightforward; however, there were no predicate filler studies of acne scars.
A proprietary assessment scale was developed, as there was no validated scale for assessing the severity of individual acne scars. An innovative photography rig was also created to effectively and consistently produce photos that captured depth of individual scars.
There was a heterogeneous distribution of acne scarring amongst eligible research participants with the number of scars per participant ranging from approximately 4 to 25. ethica created the full statistical analysis plan (SAP) to include generalized estimating equation (GEE) cumulative logit models and appropriate sensitivity testing (e.g., tipping point analyses) to address the unique presentation of acne scarring.
ethica’s accredited procedures, study management processes, and trial master file (TMF) were audited by the FDA with no 483s issued. Following product approval, ethica assisted its client in their medical affairs research program.