Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
Completed · Not applicable · Has a placebo group
Conditions studied: Wrinkles, Photoaging, Fine Lines
In brief
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.
Key facts
- Study ID
- NCT05089851
- Run by
- Revision Skincare
- People needed
- 29
- Starts
- 2020-08-23
- Expected to finish
- 2021-06-03
- Last updated by the study team
- 2021-10-28
Who can join
Age: 35 and older, up to 60. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Subjects must be willing to provide verbal understanding and written informed consent
You may not qualify if…
- 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.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Where it is running
- Shino Bay Cosmetic Dermatology and Laser Institute — Fort Lauderdale, Florida, United States
- Infinity Skin Care — Coralville, Iowa, United States
- Juvly Aesthetics — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.