Evaluation of the Efficacy and Safety of a Shiitake Mushroom Oil-Soluble Extract (SMosE) on Skin Barrier Function, Sebum Regulation, and Adaptive Responses: Preclinical and Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Soothing Test
研究概览
简要总结
This study evaluates the biological activity, safety, and clinical efficacy of SMosE (Shiitake Mushroom Oil-Soluble Extract), a topical cosmetic ingredient developed to support skin barrier function, adaptogenic responses, and sebum balance.
The investigation integrates preclinical in vitro studies, ex vivo human skin explant experiments, and a randomized, double-blind, placebo-controlled clinical trial. Preclinical models were used to explore the molecular mechanisms of action of SMosE on epidermal differentiation and barrier-related markers. The clinical phase assessed the effects of a topical formulation containing SMosE on skin hydration, transepidermal water loss, sebum production, and skin surface features in adult volunteers.
详细描述
Background and Rationale:
Skin homeostasis depends on the integrity of the epidermal barrier, balanced sebum production, and the ability of the skin to adapt to environmental stressors. Cosmetic ingredients with adaptogenic properties are increasingly investigated as non-invasive strategies to support these functions.
SMosE is an oil-soluble extract obtained from Lentinus edodes (shiitake mushroom), developed for topical use. Preliminary data suggest that SMosE may promote epidermal differentiation, improve barrier-related protein expression, and modulate sebum-related pathways.
Preclinical Evaluation:
Ex Vivo Human Skin Explant Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
neither the patient nor the investigator knows who is getting which treatment.
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects scheduled for eligibility screening at the study site
- •Female or Male sex
- •Subjects with acne prone skin or skin with scar from acne
- •Subjects exposed to sunlight for at least 4 hours a day
- •Signing the informed consent form written by the investigators
- •Certifying not taking part in another clinical study that could interfere with the current one
- •Affirming the truth of the personal information declared to the technical staff
- •Capable of following directions and reliable to respect the constraints of the protocol
- •Free to ensure the visits to the Research Lab
- •Subjects with self-perceived
- •Subjects may have mild to sensitive and stressed skin
排除标准
- •Female subjects who are pregnant, breastfeeding, or planning a pregnancy
- •Subjects with severe overall photodamage as determined by the Investigator.
- •Subjects who have any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin, including rosacea, acne, and excessively oily or dry skin.
- •Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- •Subjects' use of any medications that are known to potentially cause changes in the facial skin as determined by the Investigator.
- •Subjects who spend excessive time out in the sun.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects planning hospitalization during the study
- •Subjectsaving received vaccination within 2 weeks before the study or intending to be vaccinated during the study
- •Subjects with diseases in the period immediately preceding the current study under treatment topically or systemically with any drug that may affect the outcome of the test, particularly: systemic retinoids within 6 months, topical retinoids within 2 months anti-inflammatory or antihistamine products within the 2 weeks antibiotics within 2 weeks medication for malignancy (of any kind) within 5 years desensitization treatment within 6 months
- •Subjects in treatments with topical products based on alpha and beta-hydroxy acids in the 45 days before the start of the study
- •Subjects reactive to sun/having photosensitivity.
研究组 & 干预措施
Sample A - Active treatment
28-day-treatment, with twice daily application (morning and evening) of a cosmetic formula containing NC65 - Vita D-Light at 0.5 %w/w. The cosmetic formula is a w/o emulsion done with cosmetic-grade ingredients according to GMP. The designed quantity to be applied on the face is approximately 2 mg.
干预措施: Corthellus Shiitake(Mushroom) Extract (Other)
Sample B - Placebo treatment
28-day-treatment, with twice daily application (morning and evening) of a cosmetic formula containing the same ingredient of the active treatment except for NC65 - Vita D-Light at 0.5 %w/w. The cosmetic formula is a w/o emulsion done with cosmetic-grade ingredients according to GMP. The designed quantity to be applied on the face is approximately 2 mg.
干预措施: Placebo (Other)
结局指标
主要结局
Soothing Test
时间窗: 2 months
SOOTHING ACTION EFFICACY
次要结局
- Detox and adaptogen Test(8 months)
研究者
Ritamaria Di Lorenzo
PhD
Federico II University