Clinical Assessment of Immediate and Long-Term Effects of a Two-Step Topical Hyaluronic Acid Lip Treatment

April 2017 | Volume 16 | Issue 4 | Original Article | 366 | Copyright © April 2017

Elizabeth T. Makino BS CCRA MBA,a Priscilla Tan BA,a Kun Qian MD,b Michael Babcock MD FAAD,b and Rahul C. Mehta PhDa

aSkinMedica, Inc., an Allergan Company, Irvine, CA bThomas J. Stephens & Associates, Inc., Colorado Springs, CO


Key features of lip aging include loss of volume, color, and definition as well as increases in lines/wrinkles and uneven skin texture. A single-center, open-label clinical study was conducted to assess the efficacy and tolerability of a novel, topical two-step lip treatment (HA5 LS) in female subjects presenting with mild to moderate lip dryness and mild to severe lip condition. Subjects were instructed to apply HA5 LS at least three times a day to ensure coverage 8 hours a day for four weeks. Clinical assessments for efficacy and tolerability were conducted at baseline, baseline post-application, week 2, and week 4. Standardized digital photography, subject self-assessment questionnaires, and instrumentation measurements for skin hydration (corneometer) and lip plumpness (digital caliper) were also conducted. Thirty-six female subjects aged 22-40 years enrolled in the study. HA5 LS provided instant and long term effects, achieving significant improvements in all clinical grading parameters including lip texture, color, definition/contour, scaling, cupping, lines/wrinkles, lip plumpness, and overall lip condition from baseline post-application to week 4 (all P less than equal to .001; Wilcoxon signed-rank test). Instrumentation measurements for hydration and digital caliper at weeks 2 and 4 were also significant (all P less than equal to .032; paired t-test). HA5 LS was also well-tolerated and highly-rated by subjects throughout the study duration. Results from this study suggest that HA5 LS addresses the key features of lip aging, providing both instant and long-term benefits.

J Drugs Dermatol. 2017;16(4):366-371.


Lips are a key defining feature of the face and play an important role in conveying one’s age, attractiveness and health.1 Prominent signs of lip aging include loss of volume or lip thinning, increased appearance of vertical lines/wrinkles, and uneven texture and have a strong inverse relationship with perceived attractiveness.2,3 In addition to these key signs, lip contrast or color also plays an essential role in the aged appearance of lips. Lip color fades over time, resulting in the loss of contrast between the lips and surrounding skin and is associated with an older, aged appearance.4 Similar to facial skin aging, visible features of aged lips can be attributed to degradation of structural components of the skin, including collagen and elastic fibers.5,6 Cumulative exposure to extrinsic factors exacerbate the aging process and impact other areas of skin homeostasis, including hydration; reduced levels of hyaluronic acid (HA) and water-binding capacity have been associated with photoaged skin.7,8 This resulting loss of water-binding capacity of the skin contributes to the formation of lines/wrinkles and uneven skin texture. Lips are especially vulnerable to moisture loss because of their unique structure. Unlike facial skin, the oral mucosa is constantly exposed on the lips due to incomplete corneocyte formation.9 As a result, lips have poor water-retaining capacity which may contribute to the increased susceptibility of a wrinkled, dry, or scaling appearance.