A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging, by Comparing to a Placebo
NCT ID: NCT06804772
Last Updated: 2025-02-03
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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ACTIVE_NOT_RECRUITING
NA
15 participants
INTERVENTIONAL
2024-12-03
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
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~15 subjects, aged 35-65, will receive Investigational Facial Serum #3
Investigational Facial Serum #3
Investigational Facial Serum #3 is a placebo comparator
0 female subjects, aged 35-65, will receive Investigational Facial Serum #1
Investigational Facial Serum #1
Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.
0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2
Investigational Facial Serum #2
Investigational Facial Serum #2 is made with an active comparator.
Interventions
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Investigational Facial Serum #3
Investigational Facial Serum #3 is a placebo comparator
Investigational Facial Serum #1
Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.
Investigational Facial Serum #2
Investigational Facial Serum #2 is made with an active comparator.
Eligibility Criteria
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Inclusion Criteria
* Subject has signed a written Informed Consent prior to Day -7.
* 100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.
* 50% of subjects have self-perceived sensitive skin.
* 20% of the subjects are not 100% Caucasian.
Exclusion Criteria
* Subject is currently using medication likely to affect the response to investigational formulation.
* Subject had a fever in the last 12 hours prior to the start of the study.
* Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis; insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.
* The Subject used a form of retinol on their face in the past six months.
* The Subject used any prescription skincare products on their face in the last six months.
* The Subject has received any laser, chemical peel, or other facial resurfacing treatment such as microdermabrasion, dermablading or microneedling in the past four weeks.
* The Subject received Botox, Dysport, other muscle relaxers or injectable skin fillers in the face during the past six months.
* Subject has a known allergy or sensitivity to any ingredient in the aqueous skincare formulation provided for their use in the trial .
* Subject is currently participating in another study utilizing facial products.
* Subject is blind, visually impaired or decisionally impaired.
35 Years
65 Years
ALL
Yes
Sponsors
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Victoria Collotta
INDUSTRY
Responsible Party
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Victoria Collotta
General Manager, Branded Products, Principal Investigator
Locations
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Evolved By Nature
Needham, Massachusetts, United States
Countries
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Other Identifiers
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CLN-SKN02-011
Identifier Type: -
Identifier Source: org_study_id
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