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

A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging, Part 2

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Other: Investigational Facial Serum #3; Other: Investigational Facial Serum #1; Other: Investigational Facial Serum #2

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Needham, Massachusetts, United States, 02494
      • Evolved By Nature

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: ~15 subjects, aged 35-65, will receive Investigational Facial Serum #3	Other: Investigational Facial Serum #3; Investigational Facial Serum #3 is a placebo comparator
Experimental: 0 female subjects, aged 35-65, will receive Investigational Facial Serum #1	Other: Investigational Facial Serum #1; Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.
Active Comparator: 0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2	Other: Investigational Facial Serum #2; Investigational Facial Serum #2 is made with an active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9	Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #3 at Day 28 vs. Day 0	Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in appearance of skin characteristics	Change in surface hydration as measured by the Corneometer for subjects treated with Investigational Facial Serum #3 at Day 14 and Day 28 vs. Day 0	Day 0 to Day 28
Change in appearance of skin characteristics	Change in transepidermal water loss as measured by the Tewometer for subjects treated with Investigational Facial Serum #3 at Day 14 and Day 28 vs. Day 0.	Day 0 to Day 28

Collaborators and Investigators

• Sponsor: Victoria Collotta

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Actual): January 3, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CLN-SKN02-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No