Clinical trial NCT05089851: Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
Official title: A Randomized, Multicenter, Double-blinded, Placebo Controlled, Split-Face Study Evaluating Procedure Pairing of a Peptide Anti-Aging Serum With Onabotulinumtoxin A in the Treatment of Periorbital Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Photoaging
Fine Lines
Keywords: anti-aging
serum
onabotulinum toxin A
Botox
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 29
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face
Primary purpose: OTHER

Brief 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.

Detailed description: This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging.

Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. Investigator and subject tolerability, self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8 and 12.

A total of 29 subjects completed study participation.

Eligibility criteria: Inclusion Criteria:

1. Female subjects must be between 35-60 years of age.
2. Female subjects of childbearing potential must be willing to use a form of birth control during the study.
3. Subjects with Fitzpatrick I-VI photo skin type.
4. 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.
5. 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.
6. Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
7. Subjects must have no skin disease in the facial area being evaluated.
8. Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
9. Subjects must be willing to provide verbal understanding and written informed consent

Exclusion Criteria:

1. Female subjects who are pregnant, breast feeding, or planning a pregnancy.
2. Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
3. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
4. Subjects who are unwilling or unable to comply with the requirements of the protocol.

Primary outcomes:
measure: Clinical Efficacy Grading by Griffith's Scale
timeFrame: 12 weeks
measure: Tolerability Scores
timeFrame: 12 weeks
measure: Incidence of Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-Assessment Questionnaire
timeFrame: 12 weeks
measure: Secondary Tolerability Scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Shino Bay Cosmetic Dermatology and Laser Institute
state: Florida
city: Coralville
country: United States
facility: Infinity Skin Care
state: Iowa
city: Columbus
country: United States
facility: Juvly Aesthetics
state: Ohio
Study officials:
References: