Clinical trial NCT06804772: 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
Official title: A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging, Part 2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Aging
Lead sponsor: Evolved By Nature
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A clinical study with approximately 15 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, by comparing to a placebo.


Eligibility criteria: 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; 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 outcomes:
measure: Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9
timeFrame: Day 0 to Day 28
Secondary outcomes:
measure: Change in appearance of skin characteristics
timeFrame: Day 0 to Day 28
measure: Change in appearance of skin characteristics
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Needham
country: United States
facility: Evolved By Nature
state: Massachusetts
Study officials:
References: