Active, not recruiting
Not applicable
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
Condition(s) studied
Skin Aging
Investigational drug(s) / intervention(s)
Investigational Facial Serum #1Investigational Facial Serum #2Investigational Facial Serum #3
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.
Investigational Facial Serum #3: Investigational Facial Serum #3 is a placebo comparator
Study summary
A clinical study with approximately 40 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging.
Eligibility
Inclusion Criteria:
* Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.
* 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 pregnant, nursing, or planning to become pregnant.
* 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 (inflammation of a vein); 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.
Primary outcome measure(s)
- Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9 — Day 0 to Day 28
Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 28 vs. Day 0.
Trial sites (1)
| Facility | City | Region | Status |
| Evolved By Nature |
Needham |
Massachusetts |
|
More Victoria Collotta trials in the USA
Other trials for the same condition