The primary objective of this study is to evaluate the efficacy of DefenAge 8-in-1 BioSerum supplemented with the enhanced concentration of defensins (enhanced 8-in-1 BioSerum) in the improvement of periorbital wrinkles.
Enrolled subjects will all receive enhanced DefenAge 8-in-1 BioSerum to be applied on the face including periorbital area. Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using Canfield Vectra 3D and VISIA. Patients will return for follow-up assessments at Day 30, 60, and 90.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
DefenAge is a topical skincare brand containing a composition of biologically active natural molecules, named defensins, that repair skin damage associated with aging.
West Dermatology Research Center/Cosmetic Laser Dermatology
San Diego, California, United States
RECRUITINGClinician evaluator assessment of change using Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale
measurements will be completed based on images captured at baseline, Day 30, Day 60, and Day 90 and assessed by a blinded evaluator using the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis Scale where wrinkling ranges from class 1 (fine wrinkles) to class 3 (Fine to deep wrinkles, numerous lines, with or without redundant skin folds) and Elastosis ranges from 1-3 (mild) to 7-9 (severe)
Time frame: baseline, Day 30, Day 60, and Day 90
Asses the change of Percent of improvement at different time points
Percent improvement in periorbital wrinkles, laxity, pigmentation, erythema, texture, and radiance conducted by an evaluator
Time frame: Day 30, Day 60, and Day 90
Investigator-assessed Global Aesthetic Improvement Score (I-GAIS)
Investigator-assessed Global Aesthetic Improvement Score based on photographs where scale is 1 (much improved) to 5 (much worse)
Time frame: Day 30, 60 and 90
Subject Global Aesthetic Improvement Score (S-GAIS)
Subject Global Aesthetic Improvement Score Day 30, 60 and 90 using photographs where scale is 1 (much improved) to 5 (much worse)
Time frame: Day 30, 60 and 90
Investigator assessment of tolerability of study drug including erythema, burning/stinging, dryness, peeling (desquamation), and tenderness
Investigator assessment of tolerability of study drug
Time frame: Day 30, 60 and 90.
Patient questionnaire
Self-Assessment questionnaire
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Time frame: Day 30, 60 and 90.