P6736Tolerability and safety of a pseudoceramide-containing water in oil creamamong diabetic patients

Ward Billhimer, MS, Kao USA, Cincinnati, OH, United States; Andrea Schultz, KaoUSA, Cincinnati, OH, United States; Lisa Adams, Kao USA, Cincinnati, OH, UnitedStates; Michael Noss, MD, Radiant Research, Cincinnati, OH, United States

Diabetes affects 25.8 million (8.3%) adults and children in the United States. Aconsequence of the disease is loss of body fluids particularly to the stratum corneumwhich can lead to moderate to severe xerosis. Other common symptoms may bepresent, such as scaling, erythema, desquamation (flaking), and chapping. Inaddition, diabetics are susceptible to skin infections, and it is recommended thatdiabetic patients exercise a regular skin care regimen to help keep their skin barrierstrong and healthy. Using a cream containing moisturizing ingredients like occlu-sives, glycerin, ceramides, or pseudoceramides will help protect the stratumcorneum while keeping the skin properly moisturized. An excellent way to deliverthese ingredients is through a water in oil emulsion or cream. A key characteristic ofawater-in-oil emulsion is its hydrophobic nature and its ability to be highly occlusiveto the stratum corneum, thereby providing protection and improving the skinmoisture barrier. A 4-week clinical study was conducted using a pseudoceramide-containing cream on 60 adult diabetic patients, ages 40-79 years, inclusive. Thesepatients were currently using a medication to treat their diabetes. The primaryobjective of this study was to assess the tolerability and safety and the pseudocer-amide cream in a diabetic population. Fifty-nine patients completed the study. Allpatients applied the water in oil pseudoceramide cream twice a day on their body.Investigator Global Assessment, Skindex-16 Dermal Quality of Life, subject self-assessment, and skin conductance measures were performed at baseline and weeks2 and 4. Adverse events were monitored throughout the study. Under the studyconditions, the barrier cream appears to be safe and well accepted within a diabeticpopulation. Only 3 product-related adverse events were reported during the courseof the study. They were mild and quickly resolved. Dermal quality of life measuresindicated significant (P # .05) improvement in all 3 domains (symptoms, 7.6%;emotion, 16.7%; and functioning, 5.9%) after 4 weeks of use, suggesting improve-ment in the emotional well-being of these patients and their ability to function andinteract socially.

AB26

nsored by Kao USA.

100% spo

P6425Use of combination therapy fractionated microneedle radiofrequencywith fractional CO2 laser for the treatment of striae distensae in Koreanpatients

Kyu-Suk Lee, MD, PhD, Department of Dermatology, School of Medicine,Keimyung University, Daegu, South Korea; Gil Han, MD, Department ofDermatology, School of Medicine, Keimyung University, Daegu, South Korea;Jae-We Cho, MD, PhD, Department of Dermatology, School of Medicine, KeimyungUniversity, Daegu, South Korea

Background: Striae distensae is a significant cosmetic problem after weight gain orpregnancy rather than medical problems, which are regarded as permanent. Manytreatment modalities have been tried, but they have not been satisfactory.Microneedle radiofrequency device has been introduced to remodel of deep dermaltissue rejuvenation but there was no trial to treat stirae distensae.

Objective: To evaluate the efficacy and safety of combination therapy withfractionated microneedle radiofrequency device and fractional CO2 laser in thetreatment of striae distensae.

Methods: Twenty-one patients (21 females; mean age 33 years [range, 21-51];Fitzpatrick skin type IV) with moderate to severe striae alba or striae rubra onabdomen or calf enrolled in this study. Patientswere divided into 3 groups, fractionalCO2 laser (CICU2; ilooda, Suwon, South Korea) only, microneedle RF (Secret; ilooda,Suwon, South Korea) only, and combination of both. Each groups were treated with3 sessions at 1-month intervals. Skin biopsy on treated and nontreated sites wereperformed in 2 patients with combination method.

Results: Evaluation of improvement, which took into account with VAS (visualanalogue scale 1-3) by physician and patient. VAS score by physician showed 2.4 infractional CO2 laser treated group, 1.85 in micro RF treated group, and 3 incombination group. Score by patients showed 2.4 in fractional CO2 group, 1.85 inmicro RF group, and 3 in combination group. Through skin biopsy, we observed thatepidermis was thickened and its expression of type I collagen was increased clearlyin microneedle RF and fractional CO2 combination treated site. Transient sideeffects, such as PIH, pain, and pruritus were more common in combination group.

Conclusion: Combination therapy of fractionated microneedle RF with fractionalCO2 laser have a positive therapeutic effect and safety on striae distensae treatment.

cial support: None identified.

Commer

J AM ACAD DERMATOL

AGING/GERIATRICS

P6262A clinical evaluation of topical formulations containing a NF-kB inhibitorfor improving photoaged skin

Menas Kizoulis, Johnson & Johnson Consumer Companies, Inc, Skillman, NJ,United States; Dara Miller, Johnson & Johnson Consumer Companies, Inc,Skillman, NJ, United States; Yohini Appa, PhD, Neutrogena Corporation, LosAngeles, CA, United States

Many patients visiting the dermatologist office are focused on improving the signs offacial photoaging and they are seeking out the most effective topical skin careproducts. Despite the availability of numerous antiaging technologies, patients arestill searching for cosmetically elegant formulations that are highly effective andwell-tolerated. Recent reports have highlighted the antiaging benefits of a uniqueNF-kB inhibitor. A double-blind, randomized study was completed to assess theclinical benefits of daily usage of topical formulations containing this NF-kB inhibitorfor photoaged skin. Healthy female subjects, ages 35 to 60, exhibiting photodamageon the face, with moderate scores for 4 of the following 6 skin parameters: fine lines,wrinkles, mottled hyperpigmentation, tactile surface roughness, lack of radiance,and skin laxity were enrolled. Subjects applied the test products to their full faceonce per day for 16 weeks. In addition to the treatment cells, the study included aparallel tracking cell that was comprised of women who do not routinely use facialskin care products. All subjects were assessed at multiple time points by expertgrading, patient self-assessment and objective biophysical measures, including high-resolution clinical imaging. Statistically significant antiaging skin benefits wereobserved in all 3 assessment categories at multiple time points up to and including16 weeks. This new technology provides the practicing dermatologist with anotheroption when recommending evidence-based topical antiaging treatments.

d in full by Johnson & Johnson Consumer Companies, Inc.

Sponsore

P7003A cosmetic multiproduct regimen effectively reduces the appearance offacial hyperpigmentation

Joseph Kaczvinsky, PhD, Procter and Gamble, Cincinnati, OH, United States;James Li, MS, Procter and Gamble, Cincinnati, OH, United States; Krista Seta,Procter and Gamble, Cincinnati, OH, United States; Michael Marmor, Procter andGamble, Cincinnati, OH, United States; Tiehong Huang, MS, Procter and Gamble,Cincinnati, OH, United States; William Janson, MS, Procter and Gamble,Cincinnati, OH, United States

Hyperpigmented lesions and irregular facial pigmentation are significant contrib-utors to aged appearance and impressions of health and attractiveness in females. Assuch, a number of individual topical cosmetic products to improve the appearanceof facial hyperpigmentation have been developed. However, the use of multiplebenefit agents in a single product can often either be restricted by ingredientcompatibility issues or serve to limit the choices available to the user. Multiproductregimens can therefore serve as popular and effective alternatives. A cosmetictreatment regimen containing multiple ingredients shown to improve the appear-ance of facial hyperpigmentation was designed and evaluated via a multicenter,randomized, controlled clinical trial. The 8-week trial was conducted in 272women, 35 to 70 years old with Fitzpatrick skin types I to IV and hyperpigmentedfacial spots. The study was conducted at 2 sites in the United States, comparing thecosmetic regimen versus both a control regimen and a 4% hydroquinone regimen.Improvement in facial hyperpigmentation was determined via computer analysis ofdigital images for changes in pigmented spot area and melanin-related attributes(melanin spot area, average melanin level and distribution), and subject self-assessments. Tolerance of treatment was determined by clinical grading oferythema and subject self-assessment. Additional skin attributes, such as hydrationand skin texture, were also evaluated. Both the cosmetic regimen and 4%hydroquinone significantly reduced pigmented spot area and melanin spot areaover the 8-week trial period (P\.05) and also significantly reduced them relative tocontrol treatment. The cosmetic regimen did not reduce the mean overall melaninlevel (ie, lighten skin) but did significantly improve melanin evenness relative tocontrol after 8 weeks. Significantly higher numbers of subjects reported pigmen-tation related improvements compared to both the control and hydroquinoneregimens. The cosmetic regimen also provided significant benefits for hydrationand skin texture after 8 weeks versus 4% hydroquinone. The cosmetic regimen waswell tolerated, producing no erythema and only some slight sensory affects viasubject self-assessment.

ponsored by Procter and Gamble.

100% is s

APRIL 2013