P1608Long-lasting relief for moderate to severe dry skin with a therapeuticmoisturizing cream

Michael Suero, Johnson & Johnson Consumer & Personal Products Worldwide,Skillman, NJ, United States; Dara Miller, Johnson & Johnson Consumer & PersonalProducts Worldwide, Skillman, NJ, United States; Marilyne Candolives, Johnson &Johnson Consumer & Personal Products Worldwide, Skillman, NJ, United States;Warren Wallo, MS, Johnson & Johnson Consumer & Personal ProductsWorldwide, Skillman, NJ, United States

Patients suffering from dry skin are in constant search of an effective, long-lastingsolution. An effective moisturizer should be able to improve the visual signs ofdryness, the tactile roughness that accompanies this condition, and increase stratumcorneum water content and retard transepidermal water loss (TEWL). A dry legregression design allows for the assessment of a moisturizer’s efficacy in restoringthe skin to a hydrated state even after product application has stopped. A newtherapeutic moisturizing cream was evaluated for its ability to improve the overallcondition of dry skin. A randomized, controlled clinical study was conducted on 32healthy volunteers 18 to 65 years of age with clinically evident moderate to severexerosis, to evaluate the efficacy of the moisturizer over a 7-day use period followedby a 2-day regression period. Product application was performed on the lower laterallegs by study personnel through day 7, with no product being applied on days 8 and9. Product efficacy was determined via clinical grading of visual dryness and tactileroughness, skin conductance measurements using two different instruments, TEWLreadings, and subject self-assessments at various time points over the 9-day study.The immediate benefits of the therapeutic moisturizing cream were shown withstatistically significant increases in skin hydration levels and decreases in TEWL, asmeasured instrumentally, and significant decreases in visual dryness and tactileroughness after a single application through the 24-hour time point, as compared tothe untreated test site and its baseline scores. Twice daily applications producedcontinued significant improvements in visual dryness and tactile roughness scores,and skin conductance values from both instruments, versus the untreated site andbaseline scores throughout the 7-day treatment period. These significant improve-ments were maintained through the 48-hour regression period. Subjects alsoperceived significant improvements in the itchiness, tightness and discomfort oftheir dry skin at all the self-assessment time points. In conclusion, this newtherapeutic moisturizing cream has demonstrated its effectiveness in providing anintensive and long-lasting relief for dry skin.

AB56

cial support: Sponsored by Johnson & Johnson Consumer & PWorldwide.

Commer ersonalProducts

P1609The rapid and lasting efficacy of an oatmeal lotion in improving themoisturization and skin barrier properties of extra dry, itchy skin

Judith Nebus, Johnson and Johnson Consumer & Personal Products Worldwide,Skillman, NJ, United States; Glenn Nystrand, Johnson & Johnson Consumer andPersonal Products Worldwide, Skillman, NJ, United States; KristineSchmalenberg, PhD, Johnson & Johnson Consumer & Personal ProductsWorldwide, Skillman, NJ, United States; Warren Wallo, Johnson & JohnsonConsumer and Personal Products Worldwide, Skillman, NJ, United States

Daily routine skin moisturization is imperative to patients with compromised skinand xerosis. Body moisturizers can be strategically formulated for these skinconditions by utilizing benefit agents that help the skin to attract and retainmoisture, decrease irritation, and provide protection, which are all important inhelping to rebuild the skin barrier. Colloidal oatmeal has a long successful history ofuse in skin care mainly because its skin protectant and antiirritant properties.Colloidal oatmeal lotions with avenanthramides have been extremely beneficial topatients with an array of compromised skin conditions, even demonstratingtolerance and efficacy in babies and children with atopy. The purpose of thisclinical study was to demonstrate the efficacy of a colloidal oatmeal, skin protectantlotion with avenanthramides in improving the skin condition of patients withmoderate itch and severely dry skin. Thirty patients between the ages of 18 and 55completed the 9-day randomized, investigator blinded study. Patients used the lotiontwice a day for 7 days, followed by a 2-day regression period during which no lotionwas used. Efficacy was determined by clinical evaluations and instrumentalmeasures of moisturization and barrier function. Informed consent was obtainedfrom all study participants. Clinical evaluations showed a significant (P \ .05)improvement in skin dryness after 1 day of using the colloidal oatmeal skinprotectant lotion. Skin moisturization conductance values on day 1, after a one-timeuse of the lotion, nearly double compared to measurements obtained before thestudy began. After 4 days of using the oatmeal skin protectant lotion, patientsreported a significant improvement in itching (P \.05). Transepidermal water lossmeasurements demonstrated a significant improvement in skin barrier at this timepoint. Improvements in skin condition continued throughout the 7-day treatmentphase of the study. In addition, these improvements were maintained during the 48-hour regression phase of the study in which no product was used. In conclusion, thiscolloidal oatmeal lotion with avenanthramides demonstrated the quick efficacy inproviding relief to patients with itchy, extra dry skin by providing moisturization,relieving itching, and improving the skin barrier. In addition, this lotion was effectivein providing lasting skin benefits even after discontinuation of use for 2 days.

cial support: 100% is sponsored by Johnson & Johnson ConsProducts Worldwide.

Commer umer &Personal

J AM ACAD DERMATOL

P1610Micronized inorganic UV filter sunscreen use appears safe and efficaciousin babies and children

Alexandra Mccollum, MD, Rady Children’s Hospital & UCSD School of Medicine,San Diego, CA, United States; Hao Ouyang, PhD, Neutrogena Corporation, LosAngeles, CA, United States; Lawrence Eichenfield, MD, Rady Children’s Hospital& UCSD School of Medicine, San Diego, CA, United States; Yohini Appa, PhD,Neutrogena Corporation, Los Angeles, CA, United States

Although there is a large body of knowledge regarding sunscreen use in animals andadults, clinical trials documenting the tolerability and efficacy of sunscreen in infantsand children are scarce. Infants and children possess a relatively higher body surfaceto mass ratio than adults, and penetration, absorption, and irritation issues are ofhigher concern in the younger population. Micronized inorganic UV filters arechemically inert and do not penetrate into skin. Excellent and balanced UVA/UVBprotection can be provided in such products by combining titanium dioxide andzinc oxide without additional chemical UV filters. A randomized, double-blinded,crossover clinical study was conducted in infants and young children at RadyChildren’s Hospital in the summer of 2008 comparing the efficacy and tolerability ofa micronized inorganic filter sunscreen with a commercially available organicsunscreen as benchmark. This is a real-world usage study. Thirty infants and childrenfrom 6 months to 4 years of age were enrolled in the study. They were assignedrandomly to initially use one of the two sunscreens for 2 weeks; at the end of thisperiod they switched study products and used the other product for the following 2weeks. Subjects were assessed by pediatric dermatologists at baseline and every 2weeks for safety and tolerance and for product efficacy as measured by erythemagrading and photography. Sun exposure and sunscreen usage of the subjects wererecorded during the study period. Subjects reported an average of 28 hours in thesun during the 2-week period as well as approximately 19 applications of sunscreentotaling 34 to 39 g. The inorganic filter product showed statistically significant lackof erythema on the body when compared to the benchmark sunscreen product;however, there was no significant difference noted on the face between the twosunscreens. Two adverse events were related to the use of the benchmark organicsunscreen product while no adverse events were observed in association with theuse of the inorganic filter study sunscreen. This pilot study indicates that theinorganic filter sunscreen tested is both gentle and efficacious when used on theskin of infants and children.

cial support: Johnson and Johnson.

Commer

P1611Efficacy and substantivity evaluation of a sunscreen formulation forpeople conducting sporting activities in a high UV intensity locale

Darrell Rigel, MD, New York University Medical Center, New York, NY, UnitedStates; Hao Ouyang, PhD, Neutrogena Corporation, Los Angeles, CA, UnitedStates; Yohini Appa, PhD, Neutrogena Corporation, Los Angeles, CA, UnitedStates

Background: It has been reported that when people conduct moderate physicalactivities outdoors, sweat or heat can facilitate skin erythema reaction. Sunscreensdesigned for people conducting sport activities should then provide higherprotection level to help compensate for the changes in skin physiology. In addition,sweating or water immersion and rub-off can also compromise the performance ofthe sport sunscreen, and a sport sunscreen needs to withstand these factors.

Methods: The performance of a SPF 701 sport sunscreen was tested under real-world conditions in a double-blinded, randomized clinical study conducted in thesummer of 2008 at Vail, CO (elevation 2500 meters above sea level) for peopleplaying golf (average exposure, 4.5hours). Subjects applied sunscreen themselves inthe study. To test the substantivity of the sunscreen, one subset of the subjects (21)applied the SPF 701 sport sunscreen over the entire face at the baseline andreapplied the sunscreen in the middle of the activities (about 2hours into the UVexposure) to only one half of the face. To test the formulation’s efficacy, a secondsubset of the subjects (22) in a split-face design applied the sport sunscreen on onehalf of the face and a regular SPF 15 sunscreen on the other side at the baseline. Uponcompletion of the sport activity, a dermatologic evaluation was conducted tocompare the lateral differences between the two sides of the face for both subsets.

Results: The UV condition during the study was monitored and was such thatvirtually all of the participants would have been expected to sunburn in unprotectedskin areas. For the 21-subject reapplication group, none of the subjects could bedifferentiated in terms of increased erythema on one side by clinical examination atthe end of the exposure. No postexposure sunburn was noted clinically, althoughone subject had a slight increase in erythema. No subjects complained of symptomsof early sunburning at the time of the final evaluation. Of the 22 subjects that had SPF70 applied to one half of the face and SPF 15 applied of the other, seven hadnoticeable increased erythema on one side associated with the SPF15 sunscreen (P[ .001).

Conclusions: We found that the tested formulation is substantive to the skin and isvery effective in protecting skin from sunburns under extreme UV and real sportingconditions.

cial support: None identified.

Commer

MARCH 2010