Clinical trial NCT06148337: Eggshell Membrane Beauty From Within Trial
Official title: Evaluation of the Effects of Eggshell Membrane in Protecting Skin From Damage Caused by Environmental Challenges and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Elasticity
Skin Hydration
Skin Barrier to Water Loss
Fingernail Health
Hair Health
Lead sponsor: ESM Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 63
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, randomized, double-blind, placebo-controlled trial design
Primary purpose: SUPPORTIVE_CARE

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.

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 (IRB) and patients will provide their written informed consent to participate. The nutritional ingredient used in this study will be unhydrolyzed eggshell membrane (uESM) (Ovolux™ brand) (ESM Technologies LLC, Carthage, MO. USA), an unhydrolyzed, minimally processed chicken eggshell membrane powder.

Up to 70 subjects will be evaluated in this placebo-controlled study at a single investigational site in the U.S. Subjects will be randomly divided into two groups of equal numbers. The first group will receive a treatment protocol consisting of enough capsules to provide a daily dose of one 300 mg capsule of uESM, the second group will receive enough capsules for one capsule daily dose containing psyllium husk fiber as a placebo treatment. Subjects will take the capsules with a morning meal for 12 consecutive weeks. Assessments will be performed at baseline (Day 0), at Week 6 and again at the end of the study (Week 12).

After a period of 10-30 minutes at the study facility for acclimation to the study center environment, skin elasticity, firmness, and fatigue will be measured using the Cutometer® MPA 580 multi-probe system by applying a constant negative pressure. Trans-epidermal water loss (TEWL) will be evaluated with the Cutometer® MPA 580 multi-probe system utilizing a Tewameter® probe, and changes in skin hydration will be measured with the Cutometer® MPA 580 multi-probe system utilizing a Corneometer® probe. Subjects will also be given questionnaires to evaluate subjective responses to skin look and feel and to evaluate subjects' observations regarding changes in the condition and growth of hair and fingernails.

Eligibility criteria: Inclusion Criteria:

1. Subject must be male or female, 35-70 years of age and have a light complexion
2. Subject should be generally healthy and free of chronic skin conditions
3. Subject must be able and willing to give informed consent
4. Subject must be available for and willing to attend all evaluation visits
5. 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.)
6. 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)
7. 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 Criteria:

1. Subject has had Botox® or other facial injection (dermal filler) at or near the temple area within 6 months of screening
2. Subject has had facial cosmetic surgery affecting skin elasticity/flexibility (e.g. face lift, etc.)
3. 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
4. Subject has a known eating disorder or any dysfunction affecting the digestive tract or the ability to digest food properly
5. 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)
6. 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.)
7. 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)
8. Subject body weight is greater than 350 pounds (159 kg)
9. 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
10. Pregnant and breastfeeding women

Primary outcomes:
measure: skin elasticity/firmness
timeFrame: 6 weeks or 12 weeks
Secondary outcomes:
measure: skin hydration
timeFrame: 6 weeks or 12 weeks
measure: skin barrier function
timeFrame: 6 weeks or 12 weeks
measure: overall skin health
timeFrame: 6 weeks or 12 weeks
measure: overall hair health
timeFrame: 6 weeks or 12 weeks
measure: overall fingernail health
timeFrame: 6 weeks or 12 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Stratum Nutrition National Avenue Clinic
state: Missouri
Study officials:
affiliation: ESM Technologies, LLC d/b/a Stratum Nutrition
name: Kevin J Ruff, PhD
role: PRINCIPAL_INVESTIGATOR
References: