Clinical trial NCT06886061: Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition
Official title: Effect of Continuous Intake of Ergothioneine-containing Supplements on Skin Condition: a Randomized, Double Blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin
Keywords: Ergothioneine
Skin
Supplements
Lead sponsor: Shanghai EGT Synbio Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Brightness & Color
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
measure: Melanin
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
measure: Erythema
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
measure: Gloss (Shine)
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
measure: Elasticity
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
measure: Spots
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
Secondary outcomes:
measure: Skin Condition
timeFrame: Before the trial begins, at 4 weeks, and at 8 weeks.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Japan Clinical Trial Association N.A.
state: Shinjukuku
Study officials:
affiliation: Japan Clinical Trial Association
name: Kaneko Takeshi
role: PRINCIPAL_INVESTIGATOR
References: