Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition

NCT06886061 | Completed DMC

• 1 other identifier: UMIN000055792
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin

Keywords

Ergothioneine; Skin; Supplements

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Before the trial begins, at 4 weeks, and at 8 weeks.

Secondary Outcomes (1)

• Skin Condition

  Before the trial begins, at 4 weeks, and at 8 weeks.

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

The placebo group continuously ingests capsules without Ergothioneine over a period of 8 weeks.

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.

Dietary Supplement: The capsules contain Ergothioneine.

Interventions

The capsules contain Ergothioneine. DIETARY_SUPPLEMENT

Take one 30 mg Ergothioneine capsule orally every day for a period of eight weeks.

Ergothioneine Group

The capsules do not contain Ergothioneine. DIETARY_SUPPLEMENT

Take one capsule devoid of Ergothioneine orally every day for a period of eight weeks.

Placebo Group

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai EGT Synbio Group Co., Ltd.: lead

Study Sites (1)

Japan Clinical Trial Association N.A.

Tokyo, Shinjukuku, Japan

Location

Study Officials

• Kaneko Takeshi

  Japan Clinical Trial Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 20, 2025
• Study Start: October 9, 2024
• Primary Completion: December 10, 2024
• Study Completion: March 3, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

JP (1)