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Challenges in Dermatology Device Clinical Trials (and How to Overcome Them)

February 13th, 2019 | Clinical Trials | Dermatology | Medical Device | Article

Rising concerns about aesthetics has led to increased demand for hair- and skincare procedures. In addition, rates of skin disorders such as psoriasis, acne, eczema, and skin lesions have increased, primarily due to “irregular lifestyle and food habits,” according to a Grand View Research report.

The rise in skin disease means a heavier burden on healthcare costs. A comprehensive study published in the May 2017 Journal of the American Academy of Dermatology reports total skin disease healthcare costs increased from an estimated $28.7 million in 2004 to $44 million in 2013 (adjusted for inflation).

This increase in demand, combined with technological advancements, has paved the way for new, innovative dermatology devices. Developments in light therapy (phototherapy) in dermatology and dermatopathology aim to help people manage and treat conditions such as psoriasis, vitiligo and scleroderma, among many others.

A few interesting clinical trials in the works include:

• Northwestern University is conducting a pilot study to evaluate the effect of the Fraxel Restore 1550 nm fractional erbium-glass laser in patients with alopecia areata.

• The Skin Center Dermatology Group in New York is sponsoring a study to examine the efficacy of a non-thermal, atmospheric plasma device in the treatment of a number of different skin disorders.

• West Virginia University is sponsoring a split-face prospective trial to test the effectiveness of the Candela Family of Pulsed Dye Laser Systems on patients with perioral dermatitis. Investigators will use laser therapy on one half of the face and ask patients to also apply a topical medication to their entire face for eight weeks.

Getting a dermatology device through clinical trials to achieve FDA approval, however, comes with unique challenges. Here, we sort through a few of them.

Clinical trial design

In an article for Journal of Investigative Dermatology, author Hywel C. Williams says dermatology clinical trials are (with a few exceptions), “too small, poorly designed, and too poorly reported to reduce treatment uncertainties.”

Williams notes how frustrating it is for clinicians to read a study, only to come to a conclusion that says “more research is needed.” What’s needed, according to Williams, is not more research, but better research.

To ensure successful medical device trials, investigator and research staff need extensive dermatology experience. Allowing clinicians the opportunity to participate in, as well as lead, research may help reduce clinical uncertainties. “Clinicians are often in the best position to suggest important questions for investigator-initiated research,” Williams writes.

Site selection is also key to clinical trial success. The clinical site must have the patient population to support the trial. For an uncommon disease, certain institutions may not have the volume to support the device.

Staff training and experience, facility size, experience in medical device trials, and many other factors also determine site suitability.

Crossover trials

Dermatology, as well as numerous other therapeutic areas, use crossover trials to determine the effectiveness and/or safety of a drug or device. Crossover trials are a challenge to administer because of their complexity.

A dermatology trial may investigate a drug-and-device combination; for example, a laser treatment combined with a topical medication. In this situation, one patient may operate as his or her own control. Without careful management, the validity of the study becomes compromised.

Patient recruitment and retention

Many clinical trials fail to meet recruitment goals. Of patients that may be eligible, many choose not to participate. Why? Inconvenience, concern about safety, and the odds that it might not help their condition. It’s also common to see dropout rates between 15 and 40 percent.

Informed consent helps keep patients on board. A patient-centered approach further ups the odds of compliance. A Psoriasis Council report suggests the principal investigator and study coordinator establish personal relationships with patients.

Priority scheduling helps patients stick to the required number of office visits. Arranging transportation and childcare aren’t out of the question.

To ease patient burden, some dermatology device clinical trials incorporate telemedicine services. Using remote monitoring, patients can report certain data points without having to drive to a hospital or clinic. Sponsors can also handle recruitment, informed consent, education and compliance issues remotely. Whether a medical device manufacturer is launching a feasibility study or pivotal study, a successful dermatology device trial requires expert management. Partnering with a CRO with access to high-performing dermatology sites and a focus on patient screening, education, and retention will ensure a trial delivers the most accurate, relevant results.