Clinical Trial Review

July 2015 | Volume 14 | Issue 7 | Features | 762 | Copyright © July 2015

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit


Effect of Multiple Subcisions on Rolling Acne Scars

Sponsored by Northwestern University, the purpose of this pilot study is to find out whether the use of multiple subcisions over several visits will improve the appearance of rolling acne scars compared with no treatment. The change in acne scarring is measured using a quantitative global scarring grading system to compare baseline with the treatment. To be included in the study, subjects must have bilateral rolling acne scars on each side of their face, and no active or ongoing acne. Subjects will receive multiple subcision treatments to their randomized side of the face 5 times in total, spaced 4 weeks apart. At the start of the procedure, a straight vitrectomy knife will be inserted subdermally and slowly advanced parallel to the dermis. Rapid advancement and retraction of the needle under the scarred area in a lancing motion will be performed to abrade the underside of the dermis, followed by side to side sweeping motions attempting to break any fibrous attachments to the deeper tissues. Control subjects will receive no intervention control on the other side of the face.
table 1


An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

This open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis is designed to quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2%, in pediatric subjects with tinea corporis over a time frame of 2 weeks.
For the younger pediatric cohort, aged 2 years to 5 years 11 months, approximately 3 grams of Naftin® Cream, 2% will be applied once per day. For the older pediatric cohort, aged 6 years to 11 years, 11 months, approximately 4 grams of Naftin® Cream, 2% will be applied once per day.
Inclusion criteria include the presence of tinea corporis, characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area. Exclusion criteria include tinea infection of the scalp, face, groin, and/or feet, as well as any life-threatening condition within the last 6 months.
table 2


VELOS for the Treatment of Vascular Lesions and Skin Rejuvenation

This is a multi-center, multi-cohort, prospective, open-label study of VELOS for the treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. It will include treatment of facial skin disorders, leg veins, skin rejuvenation, and skin laxity.
The primary objective of this trial is to collect data from the use of VELOS in clinical practice under a wide range of treatment parameters variability, including RF energy and laser pulse duration for treating each of the vascular disorders. This will be conducted by documenting the physician-selected treatment parameters, as well as the subjects' clinical clearing response, perception of improvement, and sensations, through the study treatments and post-treatment(s) follow-up visits.
table 3