Sebum ProductionSMosENCT06338046
SMosE Safety and Efficacy Evaluation as a Skin Adaptogen
A study testing Corthellus Shiitake(Mushroom) Extract in people with Sebum Production and Acne Scars, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sebum Production, Acne Scars, Skin Barrier to Water Loss
- What is being tested?
- Corthellus Shiitake(Mushroom) Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II
Naples, 80131
About this study
Official title: 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
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.
Read the detailed description
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:
To confirm biological relevance in intact human tissue, ex vivo studies were performed on human skin explants. Human skin explants were obtained from three healthy female donors, aged 26 to 40 years, who underwent abdominoplasty or breast reduction surgery. All donors provided written informed consent for the use of their skin tissues in accordance with the Declaration of Helsinki. Then, protein expression of epidermal differentiation and barrier markers, including cytokeratin 10 and claudin-1, was evaluated by immunofluorescence microscopy.
Clinical Study Design:
The clinical phase was designed as a randomized, double-blind, placebo-controlled, parallel-group cosmetic study conducted at a single center.
A total of 40 adult male and female volunteers with oily and/or acne-prone skin were enrolled and randomized in a 1:1 ratio to receive either: a topical formulation containing SMosE, or a placebo formulation identical in composition except for the absence of the active ingredient. Participants applied the assigned product to the face once daily for 28 consecutive days.
Clinical Assessments:
Skin evaluations were performed at baseline and during follow-up visits under controlled environmental conditions using validated, non-invasive instruments to assess hydration, barrier function, sebum production, and skin surface features.
Safety and Ethics :
Skin tolerability was assessed prior to and throughout the study. Adverse events were monitored and recorded. All participants provided written informed consent. The study was conducted in accordance with the principles of the Declaration of Helsinki and applicable guidelines for cosmetic clinical research.
- Conditions
- Sebum Production, Acne Scars, Skin Barrier to Water Loss
- Being tested
- Corthellus Shiitake(Mushroom) Extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corthellus Shiitake(Mushroom) ExtractOther
Also called NC65 - Vita D-Light
topical treatment with Corthellus Shiitake(Mushroom) Extract
PlaceboOther
Also called Sample B
topical treatment with a placebo cosmetic formula
| Study group | Role | What they receive |
|---|---|---|
| Sample A - Active treatment | Active comparator | 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. Receives: Other: Corthellus Shiitake(Mushroom) Extract |
| Sample B - Placebo treatment | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soothing Test
SOOTHING ACTION EFFICACY
Measured: 2 months
Secondary outcomes (1)
Detox and adaptogen Test
SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Oct 2023
- Primary completion15 Nov 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sebum ProductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 parallel arm, double blind, randomized, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritamaria Di Lorenzo, Federico II University
- Investigators
- Ritamaria Di Lorenzo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338046
- Sponsor's protocol ID
- EAShi23M01
- Acronym
- SMosE
- Status last verified
- Oct 2023
- First submitted
- 23 Mar 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06338046
- Acronym / sponsor ID
- SMosE / EAShi23M01
- Conditions
- Sebum Production, Acne Scars, Skin Barrier to Water Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
To confirm biological relevance in intact human tissue, ex vivo studies were performed on human skin explants. Human skin explants were obtained from three healthy female donors, aged 26 to 40 years, who underwent abdominoplasty or breast reduction surgery. All donors provided written informed consent for the use of their skin tissues in accordance with the Declaration of Helsinki. Then, protein expression of epidermal differentiation and barrier markers, including cytokeratin 10 and claudin-1, was evaluated by immunofluorescence microscopy.
Clinical Study Design:
The clinical phase was designed as a randomized, double-blind, placebo-controlled, parallel-group cosmetic study conducted at a single center.
A total of 40 adult male and female volunteers with oily and/or acne-prone skin were enrolled and randomized in a 1:1 ratio to receive either: a topical formulation containing SMosE, or a placebo formulation identical in composition except for the absence of the active ingredient. Participants applied the assigned product to the face once daily for 28 consecutive days.
Clinical Assessments:
Skin evaluations were performed at baseline and during follow-up visits under controlled environmental conditions using validated, non-invasive instruments to assess hydration, barrier function, sebum production, and skin surface features.
Safety and Ethics :
Skin tolerability was assessed prior to and throughout the study. Adverse events were monitored and recorded. All participants provided written informed consent. The study was conducted in accordance with the principles of the Declaration of Helsinki and applicable guidelines for cosmetic clinical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel arm, double blind, randomized, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Sample A - Active treatment | Active comparator | Other: Corthellus Shiitake(Mushroom) Extract28-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. |
| Sample B - Placebo treatment | Placebo comparator | Other: Placebo28-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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corthellus Shiitake(Mushroom) ExtractAlso: NC65 - Vita D-Lighttopical treatment with Corthellus Shiitake(Mushroom) Extract | Other | Sample A - Active treatment |
| PlaceboAlso: Sample Btopical treatment with a placebo cosmetic formula | Other | Sample B - Placebo treatment |
Primary outcome
Soothing Test
Time frame: 2 months
SOOTHING ACTION EFFICACY
1 secondary outcome
Detox and adaptogen Test
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Sebum Production
Recruiting
Radiofrequency Treatment Versus Topical Therapy for Facial Acne Vulgaris
Acne Vulgaris
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritamaria Di Lorenzo principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corthellus Shiitake(Mushroom) Extract in people with Sebum Production and Acne Scars, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soothing Test (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.