Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
- Conditions
- PhotoagingWrinklesFine Lines
- Interventions
- Procedure: Onabotulinumtoxin ACombination Product: Facial CleanserCombination Product: Facial MoisturizerCombination Product: Sunscreen
- Registration Number
- NCT05089851
- Lead Sponsor
- Revision Skincare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
- Female subjects must be between 35-60 years of age.
- Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- Subjects with Fitzpatrick I-VI photo skin type.
- 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.
- 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.
- Subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors.
- Subjects must have no skin disease in the facial area being evaluated.
- Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Subjects must be willing to provide verbal understanding and written informed consent
- Female subjects who are pregnant, breast feeding, or planning a pregnancy.
- Subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the Investigator.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peptide Antiaging Serum Onabotulinumtoxin A 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 Placebo Serum Onabotulinumtoxin A 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 Peptide Antiaging Serum Facial Cleanser 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 Placebo Serum Sunscreen 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 Peptide Antiaging Serum Sunscreen 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 Placebo Serum Facial Cleanser 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 Placebo Serum Facial Moisturizer 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 Peptide Antiaging Serum Facial Moisturizer 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
- Primary Outcome Measures
Name Time Method Tolerability Scores 12 weeks 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. = SevereIncidence of Adverse Events 12 weeks 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.
Clinical Efficacy Grading by Griffith's Scale 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Secondary Tolerability Scores 12 weeks 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
1. = Mild
2. = Moderate
3. = SevereSelf-Assessment Questionnaire 12 weeks 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.
Trial Locations
- 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