atx-101 for the reduction of double chin caused by submental fat: results from the atx-101-10-16...

P6257ATX-101 for the reduction of double chin caused by submental fat: Resultsfrom the ATX-101-10-16 European phase III study

Berthold Rzany, MD, Rzany and Hund, Privatpraxis f€ur Dermatologie und€Asthetische Medizin, Berlin, Germany; Blanka Havlickova, MD, PhD, BayerHealthCare, Dermatology, Global Clinical Development, Berlin, Germany;Patricia Walker, MD, PhD, Kythera Biopharmaceuticals, Inc, Calabasas, CA,United States; Tamara Griffiths, MD, Salford Royal Hospital and the Universityof Manchester, Manchester, United Kingdom

Background: ATX-101, a proprietary formulation of synthetically derived sodiumdeoxycholate (salt of deoxycholic acid), is an investigational facial injectabletreatment for the reduction of double chin. Double chin is the result of submentalfat, and when associated with a predisposition or aging is often unresponsive to dietand exercise.

Methods: In this first of 2 pivotal phase III, multicenter, double-blind, placebo-controlled studies, 363 subjectswith submental fat rated as moderate or severewererandomly assigned (1:1:1) to receive injections of ATX-101 dosed at 1 mg/cm2 or 2mg/cm2, or placebo (vehicle). Subjects received up to 4 treatment sessions, spacedat least 28 days apart, and were followed until 12 weeks after their last treatment.Clinicians evaluated submental fat using the Clinician-Reported Submental FatRating Scale (CR-SMFRS). Subjects evaluated the amount of their submental fat usingthe Patient-Reported Submental Fat Rating Scale (PR-SMFRS), the satisfaction withtheir appearance associated with the face and chin using the Subject Self-RatingScale (SSRS), and the psychological and visual impact of their submental fat using thePatient-Reported Submental Fat Impact Scale (PR-SMFIS). Satisfaction with treat-ment was measured using the Global Post-Treatment Satisfaction Scale.

Results: At 12 weeks after last treatment, both 1 mg/cm2 and 2 mg/cm2 ATX-101groups showed a statistically significant greater improvement (P\.001) comparedto placebo in mean scores for CR-SMFRS (0.7 and 0.9, respectively, vs 0.2 withplacebo), PR-SMFRS (0.8 and 1.0 vs 0.3), and SSRS (2.4 and 2.8 vs 1.4), andpsychological and visual impact. Both ATX-101 groups also showed greatersatisfaction with treatment compared to placebo (P \ .001). The incidence oftreatment satisfaction was 79% and 91% compared to 40%. Adverse events related toATX-101 were mostly mild to moderate in severity, transient, and limited to theinjection site. The most common were pain, swelling, numbness, erythema, andinduration.

Conclusion: ATX-101 treatment was associated with a reduction in submental fatand in its psychological and visual impact, and an improvement in subjectsatisfaction with appearance and with treatment. These changes were statisticallysignificant compared to placebo. These results confirm those from the second phaseIII European study and offer evidence that ATX-101 may offer a new pharmacologicoption for reducing double chin and improving facial appearance.

AB22

d by Kythera Biopharmaceuticals, Inc.

P6729Clinical overview on the efficacy and safety of a self-occlusive topicalanesthetic cream containing lidocaine and tetracaine

Tina S. Alster, MD, Washington Institute of Dermatologic Laser Surgery,Washington, DC, United States; Daniel Stewart, DO, Skin Care Research, ClintonTownship, MI, United States; Joel L. Cohen, MD, Aboutskin Dermatology,Englewood, CO, United States; Mark Taylor, MD, Gateway Aesthetic Institute andLaser Center, Salt Lake City, UT, United States; Neil S. Sadick, MD, SadickDermatology, New York, NY, United States

Aesthetic procedures are often performed in an outpatient setting where anefficacious and expedient topical anesthesia is required. An anesthetic cream oflidocaine and tetracaine 7%/7% (LT peel) has been developed for these types ofin-office aesthetic procedures. LT peel dries after application to form a flexiblemembrane that can be easily removed before the procedure. The efficacy andsafety of LT peel has been evaluated in 9 phase III clinical studies involving morethan 500 patients. All studies were randomized, double-blind, vehicle-controlled,intraindividual comparisons. LT peel and vehicle were applied on 2 comparableareas for either 20 minutes to 30 minutes or for 60 minutes depending on theprocedure. Primary endpoint efficacy was patient-reported pain intensity using avisual analogue scale (VAS). Investigator assessed pain intensity was also evalu-ated using a 4-point scale. LT peel VAS scores were significantly lower in allstudies compared to vehicle (P \ .05). Investigator-assessed pain was alsosignificantly lower with LT peel (P\.05). All reported adverse events were mildor moderate. Edema and blanching were reported with similar frequencybetween LT peel and vehicle. Erythema was more often reported with LT peelthan vehicle. All skin reactions resolved spontaneously. The data presented hereindicate that LT peel is effective in relieving cosmetic procedure pain and is welltolerated by patients.

d by Galderma Research and Development, SNC.

J AM ACAD DERMATOL

P6666Comparative study of the efficacy and tolerability of a unique topical scarproduct versus white petrolatum following shave biopsies

Leon Kircik, MD, Physicians Skin Care, PLLC, Louisville, KY, United States;Elizabeth Makino, MBA, SkinMedica, Inc, Carlsbad, CA, United States; RahulMehta, PhD, SkinMedica, Inc, Carlsbad, CA, United States

Although skin scars are an expected outcome of the tissue repair process,patients with abnormal skin scarring may have aesthetic, psychological, andsocial consequences. With an excess of 70 million cutaneous proceduresconducted annually in the United States, there is high patient demand forproducts that will improve scarring. A novel multicomponent scar product wasdeveloped to target the main principles of scar management, including enhancedhydration, controlled inflammation, collagen maturation, and prevention oftension-mediated collagen formation. This multicomponent scar product waspreviously shown effective to improve scarring from various surgical procedures.A randomized, investigator-blinded, 8-week clinical study was conducted tocompare the tolerability and efficacy of twice-daily application of the scarproduct versus white petrolatum in subjects who have received shave biopsies.Evaluation visits were conducted at baseline and weeks 1, 2, 4, and 8. Subjectswere evaluated by the blinded investigator on parameters based on the Patientand Observer Scar Assessment Scale. Standardized digital photographs were takenat each visit and subjects completed a self-assessment questionnaire regardingeffectiveness and treatment satisfaction. Twenty-eight subjects completed the 8-week study. The scar product provided earlier and more pronounced globalimprovements compared to white petrolatum. At week 1, a significantly greaterproportion of scar product subjects had better global improvement compared towhite petrolatum subjects (P \ .05). The faster onset of improvement wasaccompanied by greater mean reductions in stinging/burning and itching withthe scar product at all visits. Importantly, subject satisfaction with the scarproduct was greater than white petrolatum at all visits.

aid for by SkinMedica, Inc.

P6139Complication of light sources: How to prevent and rectify in darker skin

Jagdish Sakhiya, MD, Sakhiya Skin Clinic Pvt Ltd, Surat, Gujarat, India

Background: In the past 2 decades, the use of different lasers by treating physicianshas increased dramitacially, combined with wide spread media attention fueling ofstrong public focus on youth and duty. The volume of laser procedure performedhas increased steadily and with this so has the number of resulting complications.Understanding the science and principles behind laser surgery can help to minimizethe potential for complications. However, as with all surgical modalities, laserprocedures results are tempered by undesirable adverse outcomes.

Methods: We have studied the complications of following light sources: IPL, CO2,fractional, CO2 ultrapulse, erbium yag, erbium glass, RF, LED, infrared, excimer,Qyag, fractional Qyag, needle RF, diode, and long pulse nd:yag in our clinic.

Results: Laser hair removal, fractional CO2 and Q-switched nd:yag, have shownmaximum complications, followed by IPL, CO2 ultrapulse, and excimer. Mostcommon complications we found where burns and pigmentatory changes anddelayed wound healing. Complications were mainly related to poor patientselection, noncompliance from patients, history of isotretinoin within the previous6 months, a lack of good health, and wrong parameter and wrong light source.

Conclusion: The chance of complications varies with delivered fluence, wave-length, pulse duration, spots size, repetition rates, laser interpulse spacing, and skinpigmentation. Regional body areas, such as the lip and groin, and chronic sunexposed tanned areas also have been associated with greater complications.

cial support: None identified.

APRIL 2013