Wrinkles, Photoaging, Fine Lines
Conditions
Keywords
anti-aging, serum, onabotulinum toxin A, Botox
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.
Interventions
PROCEDUREOnabotulinumtoxin A
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
COMBINATION_PRODUCTFacial Cleanser
Facial Cleanser to be used by participants twice daily
COMBINATION_PRODUCTFacial Moisturizer
Bland moisturizer to be used by study participants after serum twice daily.
COMBINATION_PRODUCTSunscreen
Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.
Sponsors
Revision Skincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Subjects left and right face (split face) will be randomly assigned to one of the following treatment arms: peptide antiaging serum vs placebo serum. The active and placebo will be placed in the same container and labelled Right and Left. Double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety are blinded to treatment during the twelve week randomization study. The investigational product will be identical in appearance to placebo and both will be packaged in the same container, which will be labelled Right and Left corresponding to the randomization.
Intervention model description
Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. = Severe |
| Incidence 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-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. |
| 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. = Severe |
Countries
United States
Outcome results
None listed