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

Revision Skincare29 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Wrinkles Photoaging Fine Lines

Interventions

Onabotulinumtoxin APROCEDURE

Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)

Facial CleanserCOMBINATION_PRODUCT

Facial Cleanser to be used by participants twice daily

Facial MoisturizerCOMBINATION_PRODUCT

Bland moisturizer to be used by study participants after serum twice daily.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Clinical Efficacy Grading by Griffith's Scale

The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10 point scale. A change in scores at Day 28, Day 56, and Day 84 (+/- 3 days) in comparison to baseline indicates an improvement for the indicated parameter. The efficacy parameters will be assessed at rest and at maximum smile and at specific areas on both the left and right sides of the subjects face using a modified Griffith's 10 point scale according to the following numerical definitions (half point scores may be used as necessary to more accurately describe skin conditions) 0 = None (best possible condition) 1 to 3 = Mild 4 to 6 = Moderate 7 to 9 = Severe (worst possible condition). The lower the score equates to the best possible outcome.

Time frame: 12 weeks

Tolerability Scores

The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change at Day 28, Day 56, and Day 84 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe

Time frame: 12 weeks

Incidence of Adverse Events

The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.

Time frame: 12 weeks

Secondary Outcomes

Self-Assessment Questionnaire

The secondary efficacy endpoint will be the Self-Assessment Questionnaire. A change in response values at Day 28, Day 56, and Day 84 indicates and improvement compared to baseline response values. Subjects are asked to rate based on a scoring system of the following: from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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