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

NCT06804759 | Active Not Recruiting

• 1 other identifier: CLN-SKN02-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (1)

• 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 #1 vs. Investigational Facial Serum #2 at Day 28 vs. Day 0.

  Day 0 to Day 28

Secondary Outcomes (4)

• Change in appearance of skin characteristics

  From Day 0 to Day 28

• Change in appearance of skin characteristics

  From Day 0 to Day 28

• Change in appearance of skin characteristics

  From Day 0 to Day 28

• Change in appearance of skin characteristics

  From Day 0 to Day 28

Study Arms (3)

~25 subjects, aged 35-65, will receive Investigational Facial Serum #1

EXPERIMENTAL

Other: Investigational Facial Serum #1

~15 subjects, aged 35-65, will receive Investigational Facial Serum #2

ACTIVE COMPARATOR

Other: Investigational Facial Serum #2

0 subjects, aged 35-65, will receive Investigational Facial Serum #3

PLACEBO COMPARATOR

Other: Investigational Facial Serum #3

Interventions

Investigational Facial Serum #1 OTHER

Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.

~25 subjects, aged 35-65, will receive Investigational Facial Serum #1

Investigational Facial Serum #2 OTHER

Investigational Facial Serum #2 is made with an active comparator.

~15 subjects, aged 35-65, will receive Investigational Facial Serum #2

Investigational Facial Serum #3 OTHER

Investigational Facial Serum #3 is a placebo comparator

0 subjects, aged 35-65, will receive Investigational Facial Serum #3

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• % 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.
• % of subjects have self-perceived sensitive skin.
• % of the subjects are not 100% caucasian.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Victoria Collotta: lead

Study Sites (1)

Evolved By Nature

Needham, Massachusetts, 02494, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Manager, Branded Products, Principal Investigator

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 3, 2025
• Study Start: November 18, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)