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Completed

NCT Number: NCT05089851

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

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.

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Key information

Conditions

Wrinkles Fine Lines Photoaging

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shino Bay Cosmetic Dermatology and Laser Institute, Fort Lauderdale, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Onabotulinumtoxin A

Procedure

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

Other names: Botulinum Toxin, Allergan

Facial Cleanser

Combination Product

Facial Cleanser to be used by participants twice daily

Facial Moisturizer

Combination Product

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

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.

Other names: Aveeno Face Milk SPF 40+

Primary outcomes

  1. Clinical Efficacy Grading by Griffith's Scale

    Time frame: 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.

  2. Tolerability Scores

    Time frame: 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

    • = Mild
    • = Moderate
    • = Severe

  3. Incidence of Adverse Events

    Time frame: 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 outcomes

  1. Self-Assessment Questionnaire

    Time frame: 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.

  2. Secondary Tolerability Scores

    Time frame: 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

    • = Mild
    • = Moderate
    • = Severe

Sponsors and collaborators

Lead sponsor

Revision Skincare

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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