Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines

Revision Skincare

Status: Completed

Conditions: Wrinkles; Fine Lines; Photoaging

Treatments: Combination Product: Facial Cleanser; Combination Product: Facial Moisturizer; Procedure: Onabotulinumtoxin A; Combination Product: Sunscreen

Study type: Interventional

Funder types: Industry

Identifiers

NCT05089851

RS-2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

Peptide Antiaging Serum

Active Comparator group

Description:

Dosage Form: Serum composed of water, thickener, and bioactive ingredients including peptides and antioxidants. Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization. Study Duration: 12 weeks

Treatment:

Combination Product: Facial Moisturizer

Combination Product: Sunscreen

Procedure: Onabotulinumtoxin A

Combination Product: Facial Cleanser

Placebo Serum

Placebo Comparator group

Description:

Dosage Form: Serum composed of water and thickener Frequency of Dosage: Twice daily. Subjects will be asked to pump 1x and apply to assigned facial side (left or right) corresponding to randomization. Study Duration: 12 weeks

Treatment:

Combination Product: Facial Moisturizer

Combination Product: Sunscreen

Procedure: Onabotulinumtoxin A

Combination Product: Facial Cleanser