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NCT Number: NCT06804759

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evolved By Nature

Needham, Massachusetts, 02494, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Facial Serum #1

Other

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

Investigational Facial Serum #2

Other

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

Investigational Facial Serum #3

Other

Investigational Facial Serum #3 is a placebo comparator

Primary outcomes

  1. Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9

    Time frame: Day 0 to Day 28

    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.

Secondary outcomes

  1. Change in appearance of skin characteristics

    Time frame: From Day 0 to Day 28

    Change in appearance of skin firmness through expert grading for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.

  2. Change in appearance of skin characteristics

    Time frame: From Day 0 to Day 28

    Change in surface hydration as measured by the Corneometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.

  3. Change in appearance of skin characteristics

    Time frame: From Day 0 to Day 28

    Change in transepidermal water loss measured by the Tewometer for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.

  4. Change in appearance of skin characteristics

    Time frame: From Day 0 to Day 28

    Subject reported improvements from the self-perception questionnaire with subject responses of agree, strongly agree, disagree, strongly disagree for subjects treated with Investigational Facial Serum #1 vs. Investigational Facial Serum #2 at Day 14 and Day 28 vs Day 0.

Sponsors and collaborators

Lead sponsor

Victoria Collotta

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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