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A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines

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ClinicalTrials.gov Identifier: NCT04545970
Recruitment Status : Completed
First Posted : September 11, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Ablon Skin Institute Research Center
Information provided by (Responsible Party):
Revision Skincare

Study Description
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Brief Summary:
This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Condition or disease Intervention/treatment Phase
Fine Lines Wrinkles Photoaging Combination Product: Facial cleanser Combination Product: Facial moisturizer Combination Product: Sunscreen Not Applicable

Detailed Description:

This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.

Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12.

A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description: Randomization will occur by assignment to either the active group or placebo group using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the investigator. Subjects will be assigned a number in numerical order as enrolled. The unblinded staff member will take a set of products from one of two groups of labeled active product vs. placebo and fill in the patient number and distribution date on the bottles to be dispensed to the subject.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines
Actual Study Start Date : December 23, 2019
Actual Primary Completion Date : March 11, 2020
Actual Study Completion Date : July 6, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Anti-aging Serum

Dosage form: Serum composed of water, thickener, and bioactive ingredients including antioxidants and peptides.

Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.

Study Duration: 12 weeks.

 Combination Product: Facial cleanser
Facial cleanser to be used by study participants

Combination Product: Facial moisturizer
Bland moisturizer to be used by study participants after serum in the evening.

Combination Product: Sunscreen
Sunscreen to be applied after application of serum in the morning.
Other Name: Neutrogena Sheer Zinc SPF 30
Placebo Comparator: Placebo Serum

Dosage form: Serum composed of water and thickener. Frequency of Dosage: Two times daily. Subjects are asked to pump 2x and apply on global face morning and evening.

Study Duration: 12 weeks.

 Combination Product: Facial cleanser
Facial cleanser to be used by study participants

Combination Product: Facial moisturizer
Bland moisturizer to be used by study participants after serum in the evening.

Combination Product: Sunscreen
Sunscreen to be applied after application of serum in the morning.
Other Name: Neutrogena Sheer Zinc SPF 30


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Efficacy Graded by Griffiths' Scale [ Time Frame: 12 weeks ]

    The primary efficacy endpoint will be the Investigator Clinical Grading using Modified Griffith's 10-point Scale. A decrease in scores at Day 28, Day 56 and Day 84 in comparison to baseline indicates an improvement for the indicated parameter.The efficacy parameters will be assessed globally on each subject's face using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):

    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. Objective Tolerability: scores [ Time Frame: 12 weeks ]

    The primary tolerability endpoint will be the Investigator Tolerability Assessment of Erythema, Edema and Dryness. A decrease in scores or lack of significant increase 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.

    Example for Erythema:Erythema 0 = None No erythema of the treatment area

    1. = Mild Slight, but definite redness of the treatment area
    2. = Moderate Definite redness of the treatment area
    3. = Severe Marked redness of the treatment area


Secondary Outcome Measures :
  1. Subjective Tolerability: scores [ Time Frame: 12 weeks ]

    The secondary tolerability endpoint will be the Subject Tolerability Assessment of Burning, Itching and Stinging. A decrease in scores or lack of significant increase 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.

    Example Burning. 0 = None No burning of the treatment area

    1. = Mild Slight burning sensation of the treatment area; not really bothersome
    2. = Moderate Definite warm, burning of the treatment area that is somewhat bothersome.
    3. = Severe Hot burning sensation of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep

  2. Self Assessment Questions [ Time Frame: 12 weeks ]
    The secondary efficacy endpoints will be the Self-Assessment Questionnaire and the Subject Treatment Satisfaction and Ease of Use Questionnaire. A decrease or increase in response values at Day 28, Day 56 and Day 84 indicates an 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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women between the ages of 35 and 60 years were scheduled for eligibility screening at the study site.
  • Women with Fitzpatrick Skin Type I-VI
  • Subjects must have mild to moderate global face wrinkles and fine lines
  • Subjects may have mild to moderate photo-aging secondary to physiologic aging
  • 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 as determined by the Investigator.
  • Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
  • Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
  • Subjects use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
  • Subjects who spend excessive time out in the sun.
  • Subjects who are unwilling or unable to comply with the requirements of the protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545970


Locations
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United States, California
Ablon Skin Institute Research Center
Manhattan Beach, California, United States, 90266
Sponsors and Collaborators
Revision Skincare
Ablon Skin Institute Research Center
Investigators
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Principal Investigator: Glynis Ablon, MD, FAAD Ablon Skin Institute Research Center
More Information
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Responsible Party: Revision Skincare
ClinicalTrials.gov Identifier: NCT04545970    
Other Study ID Numbers: ASIRC-RS-01
First Posted: September 11, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revision Skincare:
anti-aging
serum
Additional relevant MeSH terms:
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Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents