Status:
COMPLETED
Eggshell Membrane Beauty From Within Trial
Lead Sponsor:
ESM Technologies, LLC
Conditions:
Skin Elasticity
Skin Hydration
Eligibility:
All Genders
35-70 years
Phase:
NA
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 midd...
Detailed Description
This study will be conducted according to a single-center, randomized, double-blind, placebo-controlled trial design. The study protocol will be approved by an independent institutional review board (...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06148337
Start Date
December 27 2023
End Date
June 30 2024
Last Update
September 16 2025
Active Locations (1)
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1
Stratum Nutrition National Avenue Clinic
Springfield, Missouri, United States, 65807