A Clinical Study to Evaluate the Long-Term Efficacy and Tolerability of a Daily Anti-Aging Daily Serum
NCT ID: NCT05514782
Last Updated: 2022-10-27
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
67 participants
INTERVENTIONAL
2021-09-15
2021-12-10
Brief Summary
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Detailed Description
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Efficacy and tolerability were assessed through clinical grading at baseline, week 4, week 8, and week 12. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and overall photodamage on the global face were performed at baseline and post-baseline by a clinical grader, a board-certified dermatologist. Furthermore, blinded photo-grading at baseline and week 12 were performed by two board certified dermatologists.
Self-assessment questionnaires, Antera 3D image, Ultrasound Imaging, and VISIA photography were completed at baseline and post-baseline timepoints. Furthermore, 10 randomized subjects, a subset of the study (five in Cell 1 and five in Cell 2) had 2 mm punch skin biopsies collected from the lateral, pre-auricular at baseline and week 12.
A total of 62 subjects completed study participation (31 in Cell 1 and 31 in Cell 2).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Anti-Aging Daily Serum
Daily serum composed of a patent-pending botanical extract, bioavailable peptide, antioxidants, postbiotic(s), short term and long-term moisturizers. New product in development.
Cleansing Lotion
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Facial Moisturizer
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Sunscreen SPF 40+
Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.
Per FDA this intervention is an Over the counter
Placebo-Control
Vehicle control of the anti-aging daily serum.
Cleansing Lotion
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Facial Moisturizer
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Sunscreen SPF 40+
Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.
Per FDA this intervention is an Over the counter
Interventions
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Cleansing Lotion
Facial cleansing lotion to be used by study participants (morning and evening, 2x daily).
Facial Moisturizer
Anti-aging facial moisturizer to be used by study participants after anti-aging daily serum before sunscreen.
Sunscreen SPF 40+
Sunscreen to be applied after application of the facial moisturizer in the morning. Participants were asked to reapply every 2 hours.
Per FDA this intervention is an Over the counter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick skin type I -IV
* Moderate overall photodamage of the skin
* Moderate lack of firmness (visual) of the skin
* Moderate dull appearance of the skin
* Subjects must be willing to withhold all facial treatments during the course of the study and have not undergone a treatment within the last 6 months
* Subject must be willing to provide verbal understanding and written informed consent
Exclusion Criteria
* Nursing, pregnant, or planning to become during the duration of the study
* History of skin cancer within the past 5 years
* Having used oral isotretinoin within the last 12 months
* Having used prescription-strength skin-lightening products within the last 3 months
* Having used any anti-wrinkle, skin-lightening, or other product or topical or systemic medication known to affect skin aging or dyschromia within the last 4 weeks
* Having a health condition and/or pre-existing or dermatologic disorder that, in the Investigator's opinion, may interfere with the outcome of the study
* Having observable sunburn, suntan, scars, excessive facial hair, or other dermal conditions on the face that, in the Investigator's opinion, may influence test results
* Having a history of immunosuppression/immune deficiency disorders, or currently using oral or systemic immunosuppressive medications and biologics, and/or undergoing radiation or chemotherapy
* Using or having regularly used systemic or topical corticosteroids within the past 4 weeks
* Having started a long-term medication within the last 2 months
30 Years
60 Years
FEMALE
Yes
Sponsors
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KGL, Inc.
OTHER
Revision Skincare
INDUSTRY
Responsible Party
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Locations
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KGL Skin Study Center
West Chester, Pennsylvania, United States
Countries
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Other Identifiers
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8602
Identifier Type: -
Identifier Source: org_study_id
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