A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines
NCT ID: NCT04545970
Last Updated: 2020-09-16
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
56 participants
INTERVENTIONAL
2019-12-23
2020-07-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Facial cleanser
Facial cleanser to be used by study participants
Facial moisturizer
Bland moisturizer to be used by study participants after serum in the evening.
Sunscreen
Sunscreen to be applied after application of serum in the morning.
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.
Facial cleanser
Facial cleanser to be used by study participants
Facial moisturizer
Bland moisturizer to be used by study participants after serum in the evening.
Sunscreen
Sunscreen to be applied after application of serum in the morning.
Interventions
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Facial cleanser
Facial cleanser to be used by study participants
Facial moisturizer
Bland moisturizer to be used by study participants after serum in the evening.
Sunscreen
Sunscreen to be applied after application of serum in the morning.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
60 Years
FEMALE
Yes
Sponsors
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Ablon Skin Institute Research Center
OTHER
Revision Skincare
INDUSTRY
Responsible Party
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Principal Investigators
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Glynis Ablon, MD, FAAD
Role: PRINCIPAL_INVESTIGATOR
Ablon Skin Institute Research Center
Locations
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Ablon Skin Institute Research Center
Manhattan Beach, California, United States
Countries
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Other Identifiers
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ASIRC-RS-01
Identifier Type: -
Identifier Source: org_study_id
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