Skin Aging
Conditions
Brief 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.
Interventions
Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.
Investigational Facial Serum #2 is made with an active comparator.
Investigational Facial Serum #3 is a placebo comparator
Sponsors
Victoria Collotta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in appearance of skin characteristics | From Day 0 to Day 28 | Change in appearance of skin firmness through expert grading for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0. |
Countries
United States
Outcome results
None listed