Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
NCT ID: NCT05089851
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2020-08-23
2021-06-03
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Peptide Antiaging Serum
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
Onabotulinumtoxin A
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
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.
Placebo Serum
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
Onabotulinumtoxin A
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
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.
Interventions
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Onabotulinumtoxin A
Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
60 Years
FEMALE
Yes
Sponsors
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Revision Skincare
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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RS-2020-01
Identifier Type: -
Identifier Source: org_study_id