A Single Site, Open Label Clinical Trial, Evaluating the Duration, Efficacy, and Safety of a Novel Lip Plumper
September 2018 | Volume 17 | Issue 9 | Original Article | 999 | Copyright © September 2018
Monica Boen MD, Marwan Alhaddad MD, Isabella Guiha BSc, Douglas P. Wu MD PhD, Mitchel P. Goldman MD
Cosmetic Laser Dermatology, San Diego, CA
Abstract
Introduction: Lip plumpers are topical agents that offer immediate, but temporary, volumization of the lips. While these products are becoming increasingly popular and are available at multiple retailers, there is a lack of clinical studies to evaluate the efficacy, longevity, and safety of the lip plumping products.
Methods: This is a prospective, single center, clinical trial to evaluate the duration, efficacy, and safety of a lip plumping agent in two clinical visits. Lip volume and adverse event were assessed by two clinicians at various time points: 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours.
Results: Twenty-two subjects were enrolled in the study, and eighteen completed the study. Investigator assessments of global improvement 15 minutes after application of the lip plumping product demonstrated improvement in lip fullness in 100% of the subjects (18/18), and 1 hour post-application 67% (12/18) showed an improvement in lip fullness that was statistically significant compared to the 2-hour assessment (P less than 0.05). Subject evaluations noted improvement in lip fullness 15 minutes post-application in 94.4% (17/18) of subjects, and 1 hour post-application, 89% (16/18) of the subjects who completed the trial noted some improvement in the volume of their lips that was statistically significant compared to the 2-hour post-application time point (P less than 0.0001). Subjects noted that they did experience a tingling and heat sensation, but a majority noted that that this sensation lasted less than 15 minutes.
Discussion: Our study demonstrated that the lip plumping product increased lip volume in almost all patients 15 minutes post-application and showed a continued improvement in lip fullness per investigator assessments 1 hour after application. Adverse events of a tingling or heat sensation were expected and observed as the topical product contained capsaicin, cinnamon, and menthol, all of which can induce this sensation by the release of substance P.
J Drugs Dermatol. 2018;17(9):999-1004.
INTRODUCTION
Full and well-defined lips impart a sense of youth, attractiveness, and health.1 While the ideal lip varies across cultures, the appropriate upper to lower lip balance and a defined vermillion border has been associated a pleasing appearance of the lips.2 Lip augmentation has been on the rise in recent years, with a 53% increase in the number of lip augmentations between 2000 and 2016 according the American Society of Plastic Surgeons Statistics report.3 These increases maybe caused by the already present trend of fuller lips in Western culture, the advent of cosmetic fillers, and social media influences. In particular, the use of “selfies” in social media may have spurred patients to seek cosmetic augmentation of their lips to portray their desired lip volume in their digital images. Minimally invasive treatment options with dermal fillers can give immediate and significant benefit to the lips.4 However, due to cost, pain, and potential risk for complications, some individuals elect to opt-out of having these procedures. For these reasons, a topical lip-care treatment to temporarily plump the lips may be an attractive option to many women. Lip plumpers have been available over the counter for over a decade, however, there are few studies in the literature to evaluate their effectiveness and tolerability.5,6 This prospective study will evaluate the efficacy and safety of novel lip plumper using 3D photography, and will relay subjects’ assessment and opinions of this product.
MATERIALS AND METHODS
The study was approved by a centralized Institutional Review Board (Schulman Associates IRB, Inc.) and conducted in accordance with Good Clinical Practices conforming to the ethical guidelines of the 1975 Declaration of Helsinki.ParticipantsEligible subjects were men or women 18 years of age or older enrolled from October to November 2017. Written informed consent was obtained from all participants before study entry. Exclusion criteria included subjects with a history of sensitivity or allergy to any component of the topical lip care product; history or current evidence of a medical or current evidence of
