SMosE Safety and Efficacy Evaluation as a Skin Adaptogen (NCT06338046) | Clinical Trial Compass
CompletedNot Applicable
SMosE Safety and Efficacy Evaluation as a Skin Adaptogen
Italy40 participantsStarted 2023-10-01
Plain-language summary
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.
Who can participate
Age range25 Years – 40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 freed…