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

Victoria Collotta

Status

Active, not recruiting

Conditions

Skin Aging

Treatments

Other: Investigational Facial Serum #3

Other: Investigational Facial Serum #2

Other: Investigational Facial Serum #1

Study type

Interventional

Funder types

Industry

Identifiers

NCT06804759

CLN-SKN02-006

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.