Skin ElasticityNCT06148337
Eggshell Membrane Beauty From Within Trial
A study testing unhydrolyzed eggshell membrane in people with Skin Elasticity and Skin Hydration, run by ESM Technologies, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Elasticity, Skin Hydration, Skin Barrier to Water Loss
- What is being tested?
- unhydrolyzed eggshell membrane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stratum Nutrition National Avenue Clinic
Springfield, Missouri, 65807
About this study
Official title: Evaluation of the Effects of Eggshell Membrane in Protecting Skin From Damage Caused by Environmental Challenges and Aging
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.
Read the 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.
- Conditions
- Skin Elasticity, Skin Hydration, Skin Barrier to Water Loss, Fingernail Health, Hair Health
- Being tested
- unhydrolyzed eggshell membrane, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unhydrolyzed eggshell membraneDietary supplement
Also called uESM, Ovolux™ brand
an unhydrolyzed, minimally processed chicken eggshell membrane powder.
PlaceboDietary supplement
Also called psyllium husk fiber
psyllium husk fiber powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks or 12 weeks
Secondary outcomes (5)
skin hydration
A secondary endpoint will be any statistically significant improvement in skin hydration in the anterior region of the temporal fossa of the face based upon measurements taken with the Cutometer® MPA 580 multi-probe system.
Measured: 6 weeks or 12 weeks
skin barrier function
A secondary endpoint will be any statistically significant improvement in trans-epidermal water loss (TEWL) in the anterior region of the temporal fossa of the face based upon measurements taken with the Cutometer® MPA 580 multi-probe system.
Measured: 6 weeks or 12 weeks
overall skin health
An additional secondary endpoint will be any statistically significant improvement in overall skin health versus the placebo group as determined via a Patient's Assessment. Scoring will be from 0 to 10 with 0 equating to poor and 10 equating to excellent. Higher scores equal a better outcome.
Measured: 6 weeks or 12 weeks
overall hair health
An additional secondary endpoint will be any statistically significant improvement in hair health versus the placebo group as determined via a Patient's Assessment. Scoring will be from 0 to 10 with 0 equating to poor and 10 equating to excellent. Higher scores equal a better outcome.
Measured: 6 weeks or 12 weeks
overall fingernail health
A final secondary endpoint will be any statistically significant improvement fingernail health versus the placebo group as determined via a Patient's Assessment. Scoring will be from 0 to 10 with 0 equating to poor and 10 equating to excellent. Higher scores equal a better outcome.
Measured: 6 weeks or 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start27 Dec 2023
- Primary completion7 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ElasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, randomized, double-blind, placebo-controlled trial design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESM Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin J Ruff, PhD, Principal investigator, ESM Technologies, LLC d/b/a Stratum Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148337
- Sponsor's protocol ID
- ESM-CLN#2023T01
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Eggshell Membrane in Protecting Skin From Damage Caused by Environmental Challenges and Aging
- ClinicalTrials.gov ID
- NCT06148337
- Acronym / sponsor ID
- ESM-CLN#2023T01
- Conditions
- Skin Elasticity, Skin Hydration, Skin Barrier to Water Loss, Fingernail Health, Hair Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ESM Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, randomized, double-blind, placebo-controlled trial design
| Arm | Type | Receives |
|---|---|---|
| uESM (Ovolux brand) | Experimental | Dietary Supplement: unhydrolyzed eggshell membraneThis arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of one 300 mg capsule of uESM. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of one capsule containing psyllium husk fiber. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unhydrolyzed eggshell membraneAlso: uESM, Ovolux™ brandan unhydrolyzed, minimally processed chicken eggshell membrane powder. | Dietary supplement | uESM (Ovolux brand) |
| PlaceboAlso: psyllium husk fiberpsyllium husk fiber powder | Dietary supplement | Placebo |
Primary outcome
skin elasticity/firmness
Time frame: 6 weeks or 12 weeks
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.
5 secondary outcomes
skin hydration
Time frame: 6 weeks or 12 weeks
skin barrier function
Time frame: 6 weeks or 12 weeks
overall skin health
Time frame: 6 weeks or 12 weeks
overall hair health
Time frame: 6 weeks or 12 weeks
overall fingernail health
Time frame: 6 weeks or 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publicationOvolux™ 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
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin J Ruff, PhD principal investigator
ESM Technologies, LLC d/b/a Stratum Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unhydrolyzed eggshell membrane in people with Skin Elasticity and Skin Hydration, run by ESM Technologies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin elasticity/firmness (time frame: 6 weeks or 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148337, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.