Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition (EGTCLINIC)

March 13, 2025 updated by: Shanghai EGT Synbio Group Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Shinjukuku
      • Tokyo, Shinjukuku, Japan
        • Japan Clinical Trial Association N.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.).

Exclusion Criteria:

  • 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.

          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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks.
Dietary supplement: The capsules do not contain Ergothioneine.
Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.
Experimental: Ergothioneine Group
The Ergothioneine group continuously ingests one capsule containing 30mg of Ergothioneine per day over a period of 8 weeks.
Dietary supplement: The capsules contain Ergothioneine.
Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the trial begins, at 4 weeks, and at 8 weeks.
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.
Before the trial begins, at 4 weeks, and at 8 weeks.
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.
Before the trial begins, at 4 weeks, and at 8 weeks.
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.
Before the trial begins, at 4 weeks, and at 8 weeks.
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.
Before the trial begins, at 4 weeks, and at 8 weeks.
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.
Before the trial begins, at 4 weeks, and at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Condition
Time Frame: Before the trial begins, at 4 weeks, and at 8 weeks.
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."
Before the trial begins, at 4 weeks, and at 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai EGT Synbio Group Co., Ltd.

Investigators

  • Principal Investigator: Kaneko Takeshi, Japan Clinical Trial Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000055792

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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