Eggshell Membrane Beauty From Within Trial

NCT06148337 | Completed DMC

• 1 other identifier: ESM-CLN#2023T01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to evaluate the efficacy of oral supplementation of an unhydrolyzed eggshell membrane ingredient (uESM) vs placebo on both objective and subjective markers of skin aging in middle-aged and senior adults using the Cutometer® MPA 580 multi-probe system along with specially designed subject questionnaires. Secondary objectives will be to assess the benefits of uESM on the health of hair and fingernails based on a subject questionnaire.

Conditions

Skin Elasticity; Skin Hydration; Skin Barrier to Water Loss; Fingernail Health; Hair Health

Outcome Measures

Primary Outcomes (1)

• skin elasticity/firmness

  The primary endpoint will be any statistically significant improvement in skin firmness/elasticity in the anterior region of the temporal fossa of the face based upon measurements taken with the Cutometer® MPA 580 multi-probe system.

  6 weeks or 12 weeks

Secondary Outcomes (5)

• skin hydration

  6 weeks or 12 weeks

• skin barrier function

  6 weeks or 12 weeks

• overall skin health

  6 weeks or 12 weeks

• overall hair health

  6 weeks or 12 weeks

• overall fingernail health

  6 weeks or 12 weeks

Study Arms (2)

uESM (Ovolux brand)

EXPERIMENTAL

This arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of one 300 mg capsule of uESM.

Dietary Supplement: unhydrolyzed eggshell membrane

Placebo

PLACEBO COMPARATOR

This arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of one capsule containing psyllium husk fiber.

Dietary Supplement: Placebo

Interventions

unhydrolyzed eggshell membrane DIETARY_SUPPLEMENT

an unhydrolyzed, minimally processed chicken eggshell membrane powder.

Also known as: uESM, Ovolux™ brand

uESM (Ovolux brand)

Placebo DIETARY_SUPPLEMENT

psyllium husk fiber powder

Also known as: psyllium husk fiber

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be male or female, 35-70 years of age and have a light complexion
• Subject should be generally healthy and free of chronic skin conditions
• Subject must be able and willing to give informed consent
• Subject must be available for and willing to attend all evaluation visits
• Subject must not have used for 30 days prior to screening and be willing to discontinue use of all topical and ingested products expected to improve the health of the skin, hair, or fingernails for the duration of the study (Examples of these types of medicines are: tretinoin (Retin A®), isotretinoin (Accutane®), hyaluronic acid, collagen, topical steroids, topical antibiotics, topical retinol, topical benzoyl peroxide, topical glycolic acid, topical salicylic acid, etc.)
• Subject must not be a current smoker and have not smoked cigarettes, cigars, a pipe, etc. for 3 months prior to screening and be willing to remain non-smoking for the duration of the study (the use of 'vape' pens is allowed)
• Subjects participating in prior studies evaluating eggshell membrane can participate in the current study so long as they are not currently taking an eggshell membrane supplement and have not done so for 90 days prior to screening

You may not qualify if:

• Subject has had Botox® or other facial injection (dermal filler) at or near the temple area within 6 months of screening
• Subject has had facial cosmetic surgery affecting skin elasticity/flexibility (e.g. face lift, etc.)
• Subject has undergone any medical procedure that would materially affect the appearance, texture or elasticity of skin at or near the evaluation sites (face or arm), as judged by the clinical investigator (e.g. chemical peel, laser resurfacing, dermaplaning, microdermabrasion, etc.) within 6 months prior to screening
• Subject has a known eating disorder or any dysfunction affecting the digestive tract or the ability to digest food properly
• Subject is taking any medication or substance known to impact gastric or intestinal motility or the body's ability to break down and utilize foods (i.e., weight loss drugs)
• Subject has been diagnosed with or experienced within 30 days prior to screening any clinically significant confounding disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (e.g. an allergic response resulting in hives or other skin manifestation, an outbreak of rosacea, a severe sunburn, eczema, psoriasis, skin cancer, etc.)
• Subject has a known allergy to eggs or egg products. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study
• a. Such sensitivity may be realized as a reaction to inoculations wherein the inoculate is derived from or contains egg components (i.e., influenza vaccine)
• Subject body weight is greater than 350 pounds (159 kg)
• Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of baseline evaluation
• Pregnant and breastfeeding women

Sponsors & Collaborators

• ESM Technologies, LLC: lead

Study Sites (1)

Stratum Nutrition National Avenue Clinic

Springfield, Missouri, 65807, United States

Location

Related Publications (1)

• Ovolux™ Brand Eggshell Membrane Reduces the Clinical Signs of Aging by Improving Skin, Hair & Fingernail Appearance, Texture, and Biomechanical Properties: A Single Center, Randomized, Double Blind, Placebo Controlled Clinical Trial. https://doi.org/10.4236/jcdsa.2024.144021

  BACKGROUND

Study Officials

• Kevin J Ruff, PhD

  ESM Technologies, LLC d/b/a Stratum Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical investigator, sub-investigators, study personnel (including outcomes assessor), and study participants will be blinded to treatment until completion of the study. Only the clinical supply coordinator will be aware of treatment assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, randomized, double-blind, placebo-controlled trial design

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 28, 2023
• Study Start: December 27, 2023
• Primary Completion: April 7, 2024
• Study Completion: June 30, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)