Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in … (NCT05089851) | Clinical Trial Compass
CompletedNot Applicable
Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
United States29 participantsStarted 2020-08-23
Plain-language summary
This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. A total of 29 subjects completed study participation.
Who can participate
Age range35 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Female subjects must be between 35-60 years of age.
✓. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
✓. Subjects with Fitzpatrick I-VI photo skin type.
✓. Subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
✓. Subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified Griffith's 10-point scale.
✓. Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
✓. Subjects must have no skin disease in the facial area being evaluated.
✓. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
Exclusion criteria
✕. Female subjects who are pregnant, breast feeding, or planning a pregnancy.
✕. Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
✕. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.