A Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Tolerability of a Topical Body Treatment in Combination With Cryolipolysis Procedures
April 2019 | Volume 18 | Issue 4 | Original Article | 342 | Copyright © April 2019
Alan D. Widgerow MBBCh MMed FCS(Plast) FACS,a Amir Moradi MD MBA,b Jeanette Poehler BA CRRCc
aDepartment of Plastic Surgery, University of California, Irvine, CA; Alastin Skincare, Inc., Carlsbad, CA bAmir Moradi MD, MBA, Private Practice, Moradi MD, Vista, CA cJeanette Poehler, BA, CCRC, Moradi MD, Vista, CA
is comprehensively covered in this issue.This pilot study was designed to assess the ability of the topical body product with TriHex to speed up the process of fat dropletelimination manifesting as a more rapid clinical outcome. Although the numbers are small, the series demonstrate a statisticallysignificant improvement in contour changes at 8 weeks using the test product as opposed to the comparator. Subjective analysis demonstrated that changes in arm contour, both from investigator and subject perspectives, improved positively with the test group showing 8 weeks results equivalent to or greater than the 12-week results of the comparator and then maintaining the advantage from investigators perspective right up to the final 24-week time point. In addition, skin laxity appeared to be improved across all time periods compared to baseline. Further, more accurate objective analysis using Canfield software and measuring the baseline compared to the follow-up to receive a delta, demonstrated significant advantages at 8 and 24 weeks when subjected to statistical analysis.Although this is a pilot study, it appears that the hastened fat dissolution may be occurring at expected time points with maximalfirst signs of this evident at 8 weeks. One would then expect a certain amount of remodeling over the following few weeks and it is encouraging to see that long-term assessments at 24 weeks demonstrate an ongoing advantage.Limitations of the study include the small numbers and the difficulty in relying on subjective assessments. It is also salient to note that the upper arms in many cases have limited fat compartments and overall consistently good results with cryolipolysis may be difficult to achieve. That makes the assessment of an added topical application extra difficult to assess. Objective assessments were therefore added to the protocol and this analysis demonstrated statistical significance at the 8 and 24- week period. These points considered, it is noteworthy that this small study was able to demonstrate this significant difference between the groups tested.Due to these limitations, a further extension of the study was undertaken, also pilot in nature, to assess if objective volume assessments could improve the predictability and confidence of assessing outcomes. To this end, 3 additional subjects were chosen where procedures were conducted on the abdominal area (2 cryolipolysis, 1 radiofrequency). The body treatment with TriHex was randomized to be used on one side only and all assessments were made using the QuantifiCare LifeViz® Infinity camera and software imaging system (Quantificare Inc., San Francisco, CA). The software displays before/after 3D images to compare volume and contour changes over time. (Figures 6A, B).This small series provided objective validation of improved fat/volume reduction in all cases on the test side and provided good evidence for objective assessments in these types of studies rather than subjective photo analysis. Results of additional studies using this modality will be reported shortly.
Non-surgical fat reduction is an extremely popular procedure. Cryolipolysis is often applied as the technology of choice forupper arm contour improvement. In a study of 11 subjects, a topical product with TriHex technology was compared to a blandemollient as an adjunct to the cryolipolysis procedure. The test product appeared to speed up the process of contour improvementwith results at 8 weeks matching those attained at 12 weeks by the comparator, with long term results at 24 weeks appearing to maintain this advantage in contour improvement. When measured objectively using independent additional Canfield 3D space analysis, 8-week contour improvement was significantly better than comparator and maintained at 24-weeks. Skin laxity was also improved. In additional assessments, using objective 3D volume analysis in different anatomic areas, all cases