Multi-Center, Double-Blind, Vehicle-Controlled Clinical Trial of an Alpha and Beta Defensin-Containing Anti-Aging Skin Care Regimen With Clinical, Histopathologic, Immunohistochemical, Photographic, and Ultrasound Evaluation
Amy Taub MD,a Vivian Bucay MD,b Gregory Keller MD,c Jay Williams PhD,c and Darius Mehregan MDd
aAdvanced Dermatology/Skinfo, Lincolnshire, IL; Northwestern University Medical School, Department of Dermatology, Chicago, IL bBucay Center for Dermatology and Aesthetics, San Antonio, TX cGregory Keller Plastic Surgery, Santa Barbara, CA dWayne State University, Monroe, MI
(P=0.016). Clinically, reduction of melanin was noted in a variety of patients (Figures 10,11). Transepidermal water loss (TEWL) and skin conducting properties (hydration) were measured by this system also. The average TEWL in the FFG (11 subjects) was decreased from 32.54 mg/cm2/hour at baseline to 11.24 mg/cm2/hour after 6 weeks and to 15.02 mg/cm2/hour at 12 weeks. The PG (4 subjects) did not demonstrate improvement in TEWL, the average TEWL were 19.03 mg/cm2/hour, 15.68 mg/cm2/hour, and 24.20 mg/cm2/hour at baseline, 6 weeks, and 12 weeks, respectively. However, the P value was >0.05. The average skin electrical conductance in the FFG (8 subjects) was increased from 174.6 μS at baseline to 224.3 μS at week 12 (increasing skin conductivity reflects increased hydration).The average skin conductance in the PG (3 subjects) was 184.0 μS and 185.1 μS at baseline and 12 weeks, respectively. Although a trend was noted favorably in the FFG, no significance was established. Participants #23 and #24 (both FFG) were excluded from the analysis of TEWL and skin hydration at week 12 due to the missing data (no measurements). Participants #26 (PG) and #21 (FFG) were excluded from the analysis of skin hydration due to incorrect measurements either at baseline or week 12. Skin elasticity in a subset of 8 patients (6 FFG, 2 PG) was measured using the SkinLab Combo. The average skin retraction time in the FFG was decreased from 450 ms at baseline to 321 ms at week 12; the times in the PG were 589 ms and 598 ms at baseline and 12 weeks, respectively, demonstrating no improvement (Figure 12). However P value was >.05. Participants #16, #17, #23, and #24 (all FFG) were excluded from the analysis of skin elasticity due to the missing data at baseline (#16 and #17) or week 12 (#23 and #24; no measurements). Participants #29 (PG), #30 (PG), and #18 (FFG) were excluded from the analysis of elasticity due to incorrect measurements at week 12, electrical conductance (hydration) and retraction time (elasticity) are both very technically difficult methods. Using a high-resolution skin ultrasound, a sub-epidermal low echogenicity band (SLEB) was analyzed. We observed that 4/9 in the FFG who underwent SLEB evaluation demonstrated improvement of signs of elastosis (Figure 13). For example, participant #20 demonstrated the reduction of SLEB from 0.974 mm to 0.895 mm at 6 weeks. Zero PG participants demonstrated comparable data.
The present study shows that the full formula skin care products containing the messaging peptides alpha-defensin 5 and beta defensin 3: (1) globally improve the visual appearance of aging skin, (2) do not stimulate proliferation of cells based
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