OBJECTIVE: Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. PARTICIPANTS utilized a standardized facial cleanser and SPF15 moisturizer. SETTING: Single study center (Texas, United States; June-November 2007). PARTICIPANTS: Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II-III. MEASUREMENTS: Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05). RESULTS:Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed. CONCLUSION:Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial photodamage. TRIAL REGISTRY: Not applicable. Study precedes FDAAA 801 clinical trial registration and results submission requirements.
RCT Entities:
OBJECTIVE: Evaluate an anti-aging skin care supplement on the appearance of photodamaged skin. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. Following a one-month washout period, subjects received two anti-aging skin care formula tablets (total daily dose: marine complex 210mg, vitamin C 54mg, zinc 4mg) or placebo daily for 16 weeks. Subjects were restricted from products/procedures that may affect the condition/appearance of skin, including direct facial sun or tanning bed exposure. PARTICIPANTS utilized a standardized facial cleanser and SPF15 moisturizer. SETTING: Single study center (Texas, United States; June-November 2007). PARTICIPANTS: Healthy women aged 35 to 60 years (mean, 50 years), Fitzpatrick skin type I-IV, modified Glogau type II-III. MEASUREMENTS: Subjects were assessed at Weeks 6, 12, and 16 on clinical grading (0-10 VAS), bioinstrumentation, digital photography, and self-assessments. Analysis of variance with treatment in the model was used for between-group comparisons (alpha P≤0.05). RESULTS: Eighty-two anti-aging skin care formula subjects and 70 placebo subjects completed the study. Significant differences in change from baseline to Week 16 scores were observed for clinical grading of overall facial appearance (0.26; P<0.0001), radiant complexion (0.59; P<0.0001), periocular wrinkles (0.08; P<0.05), visual (0.56; P<0.0001) and tactile (0.48; P<0.0001) roughness, and mottled hyperpigmentation (0.15; P<0.001) favoring the subjects in the anti-aging skin care supplement group. Ultrasound skin density (Week 16) was significantly reduced for placebo versus anti-aging skin care supplement group (-1.4% vs. 0%; P<0.01). Other outcomes were not significant. Mild gastrointestinal symptoms possibly related to the anti-aging skin care supplement (n=1) and placebo (n=2) were observed. CONCLUSION:Women with photodamaged skin receiving anti-aging skin care supplement showed significant improvements in the appearance of facial photodamage. TRIAL REGISTRY: Not applicable. Study precedes FDAAA 801 clinical trial registration and results submission requirements.
Authors: Rebecca Fitzgerald; Miles H Graivier; Michael Kane; Z Paul Lorenc; Danny Vleggaar; Wm Philip Werschler; Jeffrey M Kenkel Journal: Aesthet Surg J Date: 2010 Jul-Aug Impact factor: 4.283