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

NCT05089851 | Completed FDA Device

• 1 other identifier: RS-2020-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Wrinkles; Photoaging; Fine Lines

Keywords

anti-aging; serum; onabotulinum toxin A; Botox

Outcome Measures

Primary Outcomes (3)

• 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

• 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

  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.

  12 weeks

Secondary Outcomes (2)

• Self-Assessment Questionnaire

  12 weeks

• Secondary Tolerability Scores

  12 weeks

Study Arms (2)

Peptide Antiaging Serum

ACTIVE COMPARATOR

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

Procedure: Onabotulinumtoxin A; Combination Product: Facial Cleanser; Combination Product: Facial Moisturizer; Combination Product: Sunscreen

Placebo Serum

PLACEBO COMPARATOR

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

Procedure: Onabotulinumtoxin A; Combination Product: Facial Cleanser; Combination Product: Facial Moisturizer; Combination Product: Sunscreen

Interventions

Onabotulinumtoxin A PROCEDURE

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

Also known as: Botulinum Toxin, Allergan

Peptide Antiaging Serum; Placebo Serum

Facial Cleanser COMBINATION_PRODUCT

Facial Cleanser to be used by participants twice daily

Peptide Antiaging Serum; Placebo Serum

Facial Moisturizer COMBINATION_PRODUCT

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

Peptide Antiaging Serum; Placebo Serum

Sunscreen COMBINATION_PRODUCT

Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.

Also known as: Aveeno Face Milk SPF 40+

Peptide Antiaging Serum; Placebo Serum

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revision Skincare: lead

Study Sites (3)

Shino Bay Cosmetic Dermatology and Laser Institute

Fort Lauderdale, Florida, 33301, United States

Location

Infinity Skin Care

Coralville, Iowa, 52241, United States

Location

Juvly Aesthetics

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Botulinum Toxins; Sunscreening Agents

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: August 23, 2020
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (3)