Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
NCT05089851 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2021-10-28
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.
Conditions
- Wrinkles
- Photoaging
- Fine Lines
Interventions
- PROCEDURE
-
Onabotulinumtoxin A
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
- COMBINATION_PRODUCT
-
Facial Cleanser
Facial Cleanser to be used by participants twice daily
- COMBINATION_PRODUCT
-
Facial Moisturizer
Bland moisturizer to be used by study participants after serum twice daily.
- COMBINATION_PRODUCT
-
Sunscreen
Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.
Sponsors & Collaborators
-
Revision Skincare
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-23
- Primary Completion
- 2021-06-03
- Completion
- 2021-06-03
- FDA Device
- Yes
Countries
- United States
Study Locations
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