Poster Department of Dermatology, Henry Ford Hospital, Detroit, MI; 2 Johnson & Johnson Consumer Inc., Skillman, NJ

Transcription

1 Poster 7237 A Single Center, Randomized, Double-Blinded, Multiple Exposure Evaluation of And SPF 100+ Sunscreens for Prevention of Erythema Under Actual Use Conditions Cynthia L. Nicholson MD 1, Indermeet Kohli PhD 1, Joshua Williams PhD 2, InSeok Seo PhD 2, Prithwiraj Maitra PhD 2, Henry W. Lim MD 1, Iltefat H. Hamzavi MD 1 1 Department of Dermatology, Henry Ford Hospital, Detroit, MI; 2 Johnson & Johnson Consumer Inc., Skillman, NJ

2 Disclosures Joshua D. Williams, Prithwiraj Maitra, and InSeok Seo are employed by Johnson & Johnson Consumer Inc. (Skillman, NJ, USA), the manufacturer of Neutrogena Ultra Sheer sunscreen. Henry W. Lim is a co-investigator for Estee Lauder, Johnson & Johnson, Ferndale Laboratories, Allergan, and Incyte with grant money paid to institution, and was also a consultant for Johnson & Johnson with fee paid to institution. Iltefat H. Hamzavi received honoraria as an advisory board member for Aclaris, was a consultant for Johnson & Johnson, Chromaderm, and Pfizer with fees paid to institution, consultant for Bayer with fee paid to self, and an investigator for Ferndale Laboratories, Estee Lauder, Allergan, Unigen, Incyte, Bayer, and Johnson & Johnson with grant money paid to institution. Indermeet Kohli is an investigator for Ferndale Laboratories, Estee Lauder, Johnson & Johnson, Allergan, Unigen, and Bayer with grant money paid to institution, and is a consultant for Johnson & Johnson, Chromaderm, Pfizer, and Bayer with fees paid to institution. Cynthia Nicholson has no disclosures. This study was supported by Johnson & Johnson Consumer Inc., Skillman, NJ, USA 2

3 Study Design, Participants, & Condition Side-by-side comparative evaluation for prevention of sunlight-induced erythema over multiple days at the beach Randomized: 55 participants (67% women, 45 ± 11 years, 2% Phototype I, 40% Type II, & 58% Type III), randomized to a treatment regimen for sun exposed areas of the face/body: ( left & right) or ( left & right) Double Blind: Participants, evaluator, and staff were blinded to treatment group and test product identity Test Products: Broad Spectrum - Neutrogena Ultra Sheer Dry-Touch Sunscreen Lotion, (UPC ) Broad Spectrum - Banana Boat Sport Performance with Powerstay Technology Sunscreen Lotion, (UPC ) Actual Use: Participants self-applied test products with visibility to complete sunscreen Drug Facts information minus ingredient list. Initial supervised sunscreen application occurred prior to sun exposure and participants could reapply at their discretion for the duration. Daily sun exposure period between 10 am & 3 pm with a mandatory exposure break from 12-1 pm. Assessments: Clinical & Objective erythema endpoints evaluated at baseline and morning following each sun exposure period Conditions: Conducted over a sunny Memorial Day holiday weekend at a Gulf Coast beach park near St. Petersburg, FL. 6 Period 1 Period 2 Period 3 Period 4 Period 5 5 M ED / hr Local Time Indicates mandatory sun exposure break *MED / hr, minimal erythema doses per hour 3

4 Results Clinical assessments indicate sunscreen was significantly more effective at protecting against sunlight-induced erythema than sunscreen Clinical Assessments Percentage of subjects (N = 55) The majority of participants exhibited more sunburn on the side based on total side-by-side comparisons 56.4% (31/55) Subjects more sunburned on SPF 50+ side 36.4% (20/55) No difference in sunburn 7.3% (4/55) Subjects more sunburned on side Mean erythema score (± SEM) Overall mean erythema score 1 significantly reduced on the protected side Treatment Effect: P < (N = 55) UPF 50+ Clothing Protected sunscreen provided increased sunburn protection with overall treatment effect determined to be significant for both clinical endpoints. Treatment effect significance 2 was also observed after first exposure period. Bilateral Comparison Mean Erythema Score Treatment Effect Significance Treatment Effect Significance Overall Treatment Effect 2 (N = 55) P < P < Effect By Exposure Period: Following Period 1 (N = 54) P = P = Following Periods 1 & 2 (N = 53) P < P < Following Periods 1 3 (N = 46) P = P = Following Periods 1 4 (N = 40) P < P < Following Periods 1 5 (N = 36) P = P = SEM (standard error of the mean). 1 Mean erythema score derived as averaged scores of all exposed areas from evaluations following all exposure periods, excluding evaluations for subjects once suspended from further sun exposure. 2 Treatment effect estimated as half of the difference of the two randomization group means with P-value determined using t-test at the 95% CI. 4

5 Results The additional clinical benefit of the sunscreen for enhanced protection against sunlightinduced erythema was confirmed by objective assessments Objective Assessments Overall skin redness (a*) 1 significantly reduced on the protected side 2 Overall skin oxy hemoglobin content 1 significantly reduced on the protected side 2 a* (Mean ± SEM) ± Baseline: ± 0.19 Treatment Effect: P < (N = 55) ± ± 0.18 Oxy Hemoglobin (Mean ± SEM) Baseline: ± ± Treatment Effect: P = (N = 55) ± ± sunscreen provided better protection against erythema induced by sunlight exposure with overall treatment effect determined to be significant 2 for both objective endpoints. Mean a* (skin redness) Mean Oxy Hemoglobin Treatment Effect Significance Treatment Effect Significance Overall Treatment Effect 2 (N = 55) P < P = Effect By Exposure Period: Following Period 1 (N = 55) P = P = Following Periods 1 & 2 (N = 53) P = P = Following Periods 1 3 (N = 46) P < P = Following Periods 1 4 (N = 40) P < P = Following Periods 1 5 (N = 36) P = P = SEM (standard error of the mean). Mean a* and oxy hemoglobin derived as averaged change from baseline values for all exposure sites excluding evaluations for subjects once suspended from further sun exposure. 2 Treatment effect estimated as half of the difference of the two randomization group means with P-value determined using t-test at the 95% CI. 5