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

NCT ID: NCT06804772

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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~15 subjects, aged 35-65, will receive Investigational Facial Serum #3

Group Type PLACEBO_COMPARATOR

Investigational Facial Serum #3

Intervention Type OTHER

Investigational Facial Serum #3 is a placebo comparator

0 female subjects, aged 35-65, will receive Investigational Facial Serum #1

Group Type EXPERIMENTAL

Investigational Facial Serum #1

Intervention Type OTHER

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

0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2

Group Type ACTIVE_COMPARATOR

Investigational Facial Serum #2

Intervention Type OTHER

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

Interventions

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Investigational Facial Serum #3

Investigational Facial Serum #3 is a placebo comparator

Intervention Type OTHER

Investigational Facial Serum #1

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

Intervention Type OTHER

Investigational Facial Serum #2

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Victoria Collotta

INDUSTRY

Sponsor Role lead

Responsible Party

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Victoria Collotta

General Manager, Branded Products, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Evolved By Nature

Needham, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CLN-SKN02-011

Identifier Type: -

Identifier Source: org_study_id

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