SkinEGTCLINICNCT06886061
Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition
A study testing The capsules contain Ergothioneine. and The capsules do not contain Ergothioneine. in people with Skin, run by Shanghai EGT Synbio Group Co., Ltd. at 1 site in Japan.
Trial summary
This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. Read more about this study
- Who is it for?
- Ages 35 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin
- What is being tested?
- The capsules contain Ergothioneine. and The capsules do not contain Ergothioneine.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- 9 Oct 2024to 3 Mar 2025
- 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 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ① Healthy women aged 35 to 59 years old.
- ② Individuals who feel that their skin condition is deteriorating (loss of radiance, dullness, pigmentation spots, etc.).
Who cannot join
- Individuals with a history of food allergies.
- Pregnant or breastfeeding individuals.
- Individuals with inflammation or wounds on their face.
- Individuals taking medication that could affect the trial. ⑤ Individuals consuming health supplements that could affect the trial.
- ⑥ Individuals currently undergoing medical treatment or receiving prescriptions from a doctor.
- ⑦ Individuals undergoing hormone therapy.
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- ⑧ Individuals with eyelash extensions, permanent eyeliner, or other forms of cosmetic tattooing around the eyes.
- ⑨ Individuals who have participated in human clinical trials within the last month or plan to do so during the trial period.
- ⑩ Individuals deemed unsuitable by the principal investigator of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition: a Randomized, Double Blind, Placebo-controlled Study
This trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.
Read the detailed description
Ergothioneine (EGT), a naturally occurring amino acid-like antioxidant, was first discovered in Clavieps purpurea in 1909. It is widely found in mushrooms, legumes, and certain animal tissues. Studies have shown that ergothioneine protects skin cells by scavenging free radicals and reducing oxidative stress, thereby delaying skin aging. Additionally, it can inhibit melanin production, improve uneven skin tone, enhance the skin barrier function, and boost skin elasticity and radiance. In recent years, with growing attention to nutricosmetics, ergothioneine has gained significant interest for its potential anti-aging and skin-enhancing benefits.
The trial employed a non-randomized, double-blind, placebo-controlled design, adhering to the principles of the Helsinki Declaration and relevant Japanese ethical guidelines, and received approval from an ethics review committee. The primary objective of the study was to evaluate the effects of daily consumption of one DR. ERGO® capsule (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 over an 8-week period.
The trial design included strict inclusion and exclusion criteria to ensure consistency in the health status and testing conditions of the participants. During the trial, participants were required to maintain their normal lifestyle habits and avoid using any medications or cosmetics that might affect their skin condition. The study assessed skin condition across multiple dimensions-including brightness, color tone, melanin levels, erythema, gloss, elasticity, spots, and wrinkles-using various instruments and questionnaires. Additionally, safety was monitored through diary logs and safety assessments.
- Conditions
- Skin
- Being tested
- The capsules contain Ergothioneine., The capsules do not contain Ergothioneine.
- Keywords
- Ergothioneine, Skin, Supplements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The capsules contain Ergothioneine.Dietary supplement
Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.
The capsules do not contain Ergothioneine.Dietary supplement
Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks. Receives: Dietary Supplement: The capsules do not contain Ergothioneine. |
| Ergothioneine Group | Experimental | The Ergothioneine group continuously ingests one capsule containing 30mg of Ergothioneine per day over a period of 8 weeks. Receives: Dietary Supplement: The capsules contain Ergothioneine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brightness & Color
Using the SPECTRO PHOTOMETER NF555 (Japan Electric Color Industry Co., Ltd.), measure the brightness and color at the intersection points of vertical lines below both outer canthi and horizontal lines from the alae nasi. The L*a*b* method is used to measure L* value (brightness), a* value, and b* value (color). Higher values indicate brighter or more intense colors.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Melanin
Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure melanin at the same facial points as above to assess the content of melanin.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Erythema
Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure erythema at the same facial points as above to assess the content of erythema.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Gloss (Shine)
Using the Glossymeter GL200MP (Courage+Khazaka electronic GmbH), measure the gloss at the specified facial points. This device measures true gloss unaffected by skin surface texture or color.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Elasticity
Using the Cutometer® MPA580 (Courage+Khazaka electronic GmbH), measure elasticity at the designated facial points. Skin elasticity is evaluated through R2 (total elasticity), R5 (net elasticity), and R7 (elasticity upon retraction) ratios.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Spots
Using VISIA® Evolution (Canfield Scientific Inc.), measure spots on both sides of the face at the defined locations. Assess the number of spots.
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Secondary outcomes (1)
Skin Condition
Conduct three surveys before the trial begins, and at 4 and 8 weeks into the trial, covering 11 items: "moisture," "dryness," "softness," "gloss," "smoothness," "skin allergy condition," "texture," "makeup adherence," "tightness," "wrinkles," "transparency," "tightness after washing," "brightness," and overall skin satisfaction. Participants rate these aspects on a 9-point scale ranging from "very poor" to "very good."
Measured: Before the trial begins, at 4 weeks, and at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start9 Oct 2024
- Primary completion10 Dec 2024
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SkinStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai EGT Synbio Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kaneko Takeshi, Principal investigator, Japan Clinical Trial Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886061
- Sponsor's protocol ID
- UMIN000055792
- Acronym
- EGTCLINIC
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition: a Randomized, Double Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06886061
- Acronym / sponsor ID
- EGTCLINIC / UMIN000055792
- Conditions
- Skin
- Keywords
- Ergothioneine, Skin, Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shanghai EGT Synbio Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 20 Mar 2025 (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 trial employed a non-randomized, double-blind, placebo-controlled design to evaluate the effects of DR. ERGO® Capsules (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 after continuous daily intake for 8 weeks. The trial assessed skin condition across multiple dimensions, including brightness, color tone, melanin, erythema, gloss, elasticity, and spots, using various instruments and questionnaire surveys. Additionally, safety was monitored through daily log records and safety evaluations.
Detailed description
Ergothioneine (EGT), a naturally occurring amino acid-like antioxidant, was first discovered in Clavieps purpurea in 1909. It is widely found in mushrooms, legumes, and certain animal tissues. Studies have shown that ergothioneine protects skin cells by scavenging free radicals and reducing oxidative stress, thereby delaying skin aging. Additionally, it can inhibit melanin production, improve uneven skin tone, enhance the skin barrier function, and boost skin elasticity and radiance. In recent years, with growing attention to nutricosmetics, ergothioneine has gained significant interest for its potential anti-aging and skin-enhancing benefits.
The trial employed a non-randomized, double-blind, placebo-controlled design, adhering to the principles of the Helsinki Declaration and relevant Japanese ethical guidelines, and received approval from an ethics review committee. The primary objective of the study was to evaluate the effects of daily consumption of one DR. ERGO® capsule (each containing 30mg of ergothioneine) on the skin condition of women aged 35 to 59 over an 8-week period.
The trial design included strict inclusion and exclusion criteria to ensure consistency in the health status and testing conditions of the participants. During the trial, participants were required to maintain their normal lifestyle habits and avoid using any medications or cosmetics that might affect their skin condition. The study assessed skin condition across multiple dimensions-including brightness, color tone, melanin levels, erythema, gloss, elasticity, spots, and wrinkles-using various instruments and questionnaires. Additionally, safety was monitored through diary logs and safety assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: The capsules do not contain Ergothioneine.The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks. |
| Ergothioneine Group | Experimental | Dietary Supplement: The capsules contain Ergothioneine.The Ergothioneine group continuously ingests one capsule containing 30mg of Ergothioneine per day over a period of 8 weeks. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ① Healthy women aged 35 to 59 years old.
- ② Individuals who feel that their skin condition is deteriorating (loss of radiance, dullness, pigmentation spots, etc.).
Key exclusion criteria (9 listed)
- Individuals with a history of food allergies.
- ⑥ Individuals currently undergoing medical treatment or receiving prescriptions from a doctor.
- ⑦ Individuals undergoing hormone therapy.
- ⑧ Individuals with eyelash extensions, permanent eyeliner, or other forms of cosmetic tattooing around the eyes.
- ⑨ Individuals who have participated in human clinical trials within the last month or plan to do so during the trial period.
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 |
|---|---|---|
| The capsules contain Ergothioneine.Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks. | Dietary supplement | Ergothioneine Group |
| The capsules do not contain Ergothioneine.Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks. | Dietary supplement | Placebo Group |
Primary outcome
Brightness & Color
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using the SPECTRO PHOTOMETER NF555 (Japan Electric Color Industry Co., Ltd.), measure the brightness and color at the intersection points of vertical lines below both outer canthi and horizontal lines from the alae nasi. The L*a*b* method is used to measure L* value (brightness), a* value, and b* value (color). Higher values indicate brighter or more intense colors.
Melanin
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure melanin at the same facial points as above to assess the content of melanin.
Erythema
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using the Mexameter® MX 18 (Courage+Khazaka electronic GmbH), measure erythema at the same facial points as above to assess the content of erythema.
Gloss (Shine)
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using the Glossymeter GL200MP (Courage+Khazaka electronic GmbH), measure the gloss at the specified facial points. This device measures true gloss unaffected by skin surface texture or color.
Elasticity
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using the Cutometer® MPA580 (Courage+Khazaka electronic GmbH), measure elasticity at the designated facial points. Skin elasticity is evaluated through R2 (total elasticity), R5 (net elasticity), and R7 (elasticity upon retraction) ratios.
Spots
Time frame: Before the trial begins, at 4 weeks, and at 8 weeks.
Using VISIA® Evolution (Canfield Scientific Inc.), measure spots on both sides of the face at the defined locations. Assess the number of spots.
1 secondary outcome
Skin Condition
Time frame: Before the trial begins, at 4 weeks, and at 8 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 20 Mar 2025.
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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.
Kaneko Takeshi principal investigator
Japan Clinical Trial Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The capsules contain Ergothioneine. and The capsules do not contain Ergothioneine. in people with Skin, run by Shanghai EGT Synbio Group Co., Ltd. at 1 site in Japan.
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 2 inclusion and 9 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 20 Mar 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 Japan. 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?
Brightness & Color (time frame: Before the trial begins, at 4 weeks, and at 8 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.