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

Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05089851
• Other study ID #: RS-2020-01
• Status: Completed
• Phase: N/A
• Start date: August 23, 2020
• Est. completion date: June 3, 2021

Study information

• Verified date: October 2021
• Source: Revision Skincare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fine Lines
• Photoaging
• Wrinkles

Intervention

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

Locations

Country	Name	City	State
United States	Juvly Aesthetics	Columbus	Ohio
United States	Infinity Skin Care	Coralville	Iowa
United States	Shino Bay Cosmetic Dermatology and Laser Institute	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revision Skincare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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; = Mild; = Moderate; = Severe	12 weeks
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Secondary Tolerability Scores	The secondary tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change at Day 28, Day 56, Day 84, and Day 168 in comparison to baseline indicates tolerability / safety of the test material. Four point scale with a lower score indicating a better outcome.; 0 = None; = Mild; = Moderate; = Severe	12 weeks