BACKGROUNDDermal fillers are used to augment wrinkles and folds, and a variety of hyaluronic acid (HA)-based products are available. The non-animal-sourced HA studied was cross-linked using a two-step process and employing cohesive polydensified matrix (CPM) technology. This HA gel (CPMHA) has variable density and viscosity zones for adaptation in the dermis.OBJECTIVETo compare the safety and effectiveness of CPMHA with that of bovine collagen (COL) in the correction of moderate to severe nasolabial folds (NLFs) in a split-face study.METHODS AND MATERIALSOne hundred eighteen subjects were randomized to receive CPMHA and COL on contralateral sides of the face. NLF severity was measured using the Wrinkle Severity Rating Scale (WSRS). The initial treatment was evaluated after 2 weeks, and an optional touch-up to optimal cosmetic correction was permitted if needed. Subjects returned every 2 weeks (up to 24 weeks) for evaluation. Safety was assessed using spontaneous adverse event (AE) reporting.RESULTSCPMHA resulted in a significantly greater reduction in the mean change of WSRS than COL at weeks 8 (p=.009), 12 (p <.001), 16 (p <.001), and 24 (p <.001). There were no significant differences between the two groups in the proportion of AEs considered related to the injection site procedure. Most AEs were mild to moderate in severity and resolved within 7 days.CONCLUSIONCPMHA was well tolerated and first demonstrated to be noninferior and then superior in terms of effectiveness to COL over 24 weeks for the treatment of NLF, including the primary end point at week 12.Merz Pharmaceuticals, LLC funded this Food and Drug Administration clinical trial. Bhushan Hardas, Mandeep Kaur, Starr Grundy, and Eric Pappert are employees of Merz Pharmaceuticals.

ing & Indexing: The journal is indexed in Index Medicus/MEDLINE. Pulse Marketing & Communications, LLC 4 Peninsula Avenue • Suite 401 • Sea Bright, NJ 07760 • Tel (732) 747-6525 • Fax (732) 747-7010 Corporate Publishing Editorial BRIEF SUMMARY Rx ONLY INDICATIONS AND USAGE: Naftin® Cream, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. Naftin® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans*, Epidermophyton floccosum*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections. CONTRAINDICATIONS: Naftin® Cream and Gel, 1% are contraindicated in individuals who have shown hypersensitivity to any of their components. WARNINGS: Naftin® Cream and Gel, 1% are for topical use only and not for ophthalmic use. PRECAUTIONS: General: Naftin® Cream and Gel, 1%, are for external use only. If irritation or sensitivity develops with the use of Naftin® Cream or Gel, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Information for patients: The patient should be told to: 1. Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician. 2. Keep Naftin® Cream and Gel, 1% away from the eyes, nose, mouth and other mucous membranes. Carcinogenesis, mutagenesis, impairment of fertility: Long-term studies to evaluate the carcinogenic potential of Naftin® Cream and Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility. Pregnancy: Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftin® Cream or Gel,1% are administered to a nursing woman. Pediatric use: Safety and effectiveness in pediatric patients have not been established. ADVERSE REACTIONS: During clinical trials with Naftin® Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%) erythema (2%), itching (2%), local irritation (2%). During clinical trials with Naftin® Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%). Manufactured for Merz Pharmaceuticals, Greensboro, NC 27410 © 2010 Merz Pharmaceuticals Rev 3/10 skinmedbriefPI.indd 1 4/5/10 4:50 PM GENERAL COUNSEL Marianne Mckenzie mmckenzie@skinmedjournal.com SAVE THE DATE FOR THE 7th Annual Maui Derm A Pan-Pacifi c Thought Leaders Meeting FEBRUARY 23-27, 2011 GRAND WAILEA, MAUI Save the Date & Register Early! $395 before June 30th! Plan to attend the 7th Annual Maui Derm Conference! “Cutting edge, a great blend of science and clinical medicine and a world class faculty” describe Maui Derm 2011. Our faculty will share with you the most important developments in medical and cosmetic dermatology vital to your practice. Our live patient demonstration workshops in lasers, Botulinum Toxin A and fi llers have set the standard for “hands on” workshops. Our format has been specifi cally designed to allow optimal time for discussion with our faculty. We are certain that you will fi nd this to be an outstanding and memorable educational event that you will not want to miss. Put Maui Derm on your calendar for 2011! FEATURED LECTURES Medical Dermatology Skin Cancer/Chemoprevention • Acne/Rosacea • Pediatric Dermatology • Infectious Diseases • Psoriasis • Pigmentary Disorders • Contact Dermatitis • Cosmeceuticals • Collagen Vascular Diseases • Offi ce Surgery Tips Practice Management • Skin of Color Cosmetic Dermatology Botulinum Toxin A and Fillers • Lasers • Skin of Color “Lunch with the Faculty” – Controversial Topics, Case-based Discussions Interactive Workshops Small Group, Live Patient, Hands-On Demonstrations: Botulinum Toxins/Fillers Maui Derm 2011 has special/reduced rates at the Grand Wailea and the Wailea Marriott For more details, visit our website at www.acmd-derm-hawaii.com MAUI DERM 2011 FACULTY Chairman: Dr. George Martin Dr. Rox Anderson Dr. Andrew Blauvelt Dr. Joel Cohen Dr. Lawrence Eichenfi eld Dr. Ilona Frieden Dr. Sheila Fallon-Friedlander Dr. Michael Gold Dr. Mitchel Goldman Dr. Pearl Grimes Dr. Arthur Kavanaugh Dr. Suzanne Kilmer Dr. David Laub Dr. Craig Leonardi Dr. Stuart Maddin Dr. Sam Moschella Dr. Stuart Nelson Dr. Kevin Pinski Dr. Ted Rosen Dr. Vic Ross Dr. Alan Shalita Dr. Bruce Strober Dr. Hensin Tsao Dr. Sandy Tsao Dr. Guy Webster Dr. Philip Werscheler

BACKGROUNDRepeat treatments of nonpermanent dermal fillers are used in the long-term treatment of wrinkles and folds and to volumize.OBJECTIVETo determine the safety and effectiveness of a nonanimal-sourced hyaluronic acid (HA) (which uses a cohesive polydensified matrix (CPM) technology [CPMHA]) for the treatment of nasolabial folds (NLFs) during an 18-month open-label extension trial.METHODS AND MATERIALSNinety-five of 118 subjects continued with this optional open-label extension of a split-face, double-blind trial. All subjects received CPMHA in both NLFs at 24 weeks after treatment in this study and were assessed at weeks 32, 48, 72, and 96. Touch-ups were allowed for optimal correction. Safety was assessed according to reported adverse events (AEs) and serum antibody measurement.RESULTSAt all four post-week 24 time points, the severity of the NLFs showed a decrease from baseline on the Wrinkle Severity Rating Scale. The effects persisted in the majority (similar to 80%) of subjects without repeat treatment for at least one interval of 48 weeks. The study filler was well tolerated, with only one related AE (injection site bruising) reported. Little potential for immunogenic reactions was identified.CONCLUSIONThis CPMHA is a well-tolerated and effective treatment for at least 48 weeks in the majority of subjects for the correction of moderate to severe NLFs with repeat injections given over an 18-month period.This study was sponsored by Merz Pharmaceuticals, LLC. B. Hardas, M. Kaur, S. Grundy, and E. Pappert are employees of Merz. The authors were compensated for their work as investigators.

This study evaluated the effect of an onion extract cream with Centella asiatica and hyaluronic acid in improving the appearance of striae rubra (SR). Women participants with bilateral, outer aspect of the thigh SR were randomized to apply a quarter-sized amount of the onion extract cream twice daily for 12 weeks to the randomized left or right, outer aspect of the thigh. No treatment was administered to the contralateral side. Participants were evaluated at weeks 2, 4, 8, and 12. Primary efficacy endpoints included color, texture, softness, and overall appearance of SR by the participant and investigator at week 12. The treated thigh demonstrated a statistically significant difference in the mean change in participant and investigator evaluations in overall appearance, texture, color, and softness compared with the untreated thigh at week 12. No adverse events occurred during the study. The onion extract cream was well tolerated and significantly improved the appearance of SR in women.

Dermatologic Surgery: May 2010 - Volume 36 - Issue 1 - p 729 doi: 10.1111/j.1524-4725.2010.01578.x

BACKGROUND:As with other facial wrinkles, the gradual loss and disorganization of collagen fibers and elastin, connective tissues that provide underlying support for skin, cause horizontal forehead rhytides in large part.OBJECTIVES:To develop the Forehead Lines Grading Scale for objective quantification of horizontal forehead rhytides at rest and with expression and to establish the reliability of this photonumeric scale for clinical research and practice.MATERIALS AND METHODS:The Forehead Lines Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients.RESULTS:The agreement between the experts was highly significant. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts.CONCLUSION:The 5-point photonumeric scale generated spans the severity of forehead lines for which patients commonly seek correction. The scale is well stratified for consistent rating.

BACKGROUND Following the popularity of facial cosmetic procedures to reverse the signs of aging, cosmetic procedures that rejuvenate the hand are being sought. Irregular surface pigmentation, prominence of superficial veins and tendons, thinning of the dermis, and loss of subcutaneous fat typically characterize aging of the hand. OBJECTIVES To develop the Hand Grading Scale for objective quantification of the severity of hand aging and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS The Hand Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify the severity of aging of the hand. Nine experts rated photographs of 35 subjects, twice, with regard to the aspect "hand aging" in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS The agreement between the experts was considerably high. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION The 5-point photonumeric scale generated spans the severity of hand aging for which patients most commonly seek correction. The scale is well stratified for consistent rating.

OBJECTIVES To develop the Lip Fullness Grading Scale for objective quantification of lip volume for a reliable assessment and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS A 5-point photonumeric rating scale was developed to objectively quantify fullness of upper and lower lip separately. Nine experts rated photographs of 35 subjects, twice, separately for upper and lower lip. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS Agreement between the experts was high. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION The 5-point photonumeric scale generated spans the fullness of the upper and lower lip for which patients commonly seek correction. This scale is well stratified, with low intra- and interrater variability.

BACKGROUND One of the first areas to show facial aging is the periorbital region, where brow malposition contributes to the overall appearance of aging. Movement and positioning of the brows are also sex specific. Men may desire a low brow, whereas women may prefer high, arched brows. OBJECTIVES To develop the Brow Positioning Grading Scale for objective quantification of eyebrow position and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS A 5-point photonumeric rating scale was developed to objectively quantify positioning of eyebrows at rest. Nine experts rated photographs of 35 subjects twice with regard to positioning of the eyebrow in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. The test–retest correlation coefficients were acceptable for each expert. CONCLUSION The 5-point photonumeric scale generated spans the positioning of the eyebrow for which patients commonly seek correction. The scale is well stratified for consistent rating.

OBJECTIVE To develop the Crow's Feet Grading Scale for objective quantification of the severity of lateral canthal lines and to establish the reliability of this photonumeric :scale for clinical research and practice.MATERIALS AND METHODS A 5-point photonumeric rating scale was developed to objectively quantify the severity of lateral canthal lines at rest and at maximum contracture of the orbicularis oculi. Nine experts rated photographs of 35 subjects, twice, with regard to the aspect crow's feet in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients.RESULTS The agreement between the experts was significantly high. Furthermore, the test-retest correlation coefficients were high for each expert after an overnight interval, demonstrating low inter- and intraevaluator variability.CONCLUSION The 5-point photonumeric scale generated spans the severity of the type of crow's feet for which patients most commonly seek correction. The scale is well stratified for consistent rating.