Itchy ScalpNCT07805031
Itchy Scalp Biomarkers Exploration
An observational study of Itchy Scalp and Pruritus, run by L'Oreal at 1 site in China.
Trial summary
This is a single-center, cross-sectional, observational clinical study to investigate the clinical attributes and lipidomic signatures of itchy scalp with and without dandruff, aiming to validate the biological distinctiveness of pure scalp pruritus. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Itchy Scalp, Pruritus, Dandruff
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2025to 15 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Chinese female volunteers aged 18 to 50 residing in Shanghai, China, recruited from the clinical testing center. The study population comprises healthy individuals with normal scalp conditions as well as individuals presenting with scalp pruritus with or without dandruff, stratified into three distinct cohorts based on pruritus VAS scores and adherent dandruff photographic scales (DFS).
Who may be able to join
- Female volunteer from 18 to 50 years old, in good general health (physical, mental, and social well-being) according to volunteer self-declaration and investigator's opinion.
- Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study and throughout the study.
- Female of childbearing potential willing to undergo urine pregnancy test.
- Volunteer has the life habit of washing hair twice to 7 times every week.
- Volunteer has scalp conditions based on group:
- Group 1 i. Self-declared normal scalp without pruritus, score=0 on pruritus Visual Analog Scale (VAS).
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- Adherent dandruff score ≤0.5 based on Dandruff Photographic Scales (DFS) assessed by dermatologist.
- Group 2 i. Scalp pruritus score ≥4 and ≤8 on pruritus VAS. ii. Adherent dandruff score ≥2 and ≤4 based on DFS assessed by dermatologist. c. Group 3 i. Scalp pruritus score ≥4 and ≤8 on pruritus VAS. ii. Adherent dandruff score ≤0.5 based on DFS assessed by dermatologist.
- Volunteer with Asian scalp.
- Volunteer living in Shanghai for at least one year.
- Volunteer willing and able to fulfil the study requirements and schedule.
- Volunteer informed about the study objectives and procedures, and able to understand them.
- Volunteer who has given written informed consent.
Who cannot join
- Volunteer who is pregnant or lactating or who is planning to become pregnant during the study.
- Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
- Volunteer who has hair treatments including hair coloration, bleaching or perm within 3 months before inclusion.
- Volunteer who has skin cancer, severe autoimmune skin diseases or other moderate or severe skin diseases.
- Volunteer who has Seborrheic dermatitis, psoriasis, scalp pityriasis, tinea capitis, atopic dermatitis, folliculitis, alopecia or other skin disorders might interfere the assessment on scalp or calves determined by the dermatologist.
- Volunteer who has diagnosed endocrine disorders (e.g. hypopituitarism, diabetes mellitus, polycystic ovary syndrome), auto-immune medical conditions (e.g. systemic lupus erythematosus (SLE) and Rheumatoid arthritis (RA)), hyper- or hypothyroidism, hypertension or mental illness (e.g. diagnosed depression, schizophrenia, trichotillomania).
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- Volunteer who has active gastrointestinal (GI) bleeding or history of heart or vascular disease.
- Volunteer who has systemic medication (e.g. steroidal and non-steroidal anti-inflammatory drugs, corticoids, insulin, antihistamines, hormones, antihypertensive, antibiotics such as quinolone, tetracycline, thiazides, fluoroquinolones) within one month before inclusion.
- Volunteer who has topical treatments of prescription, over-the-counter remedies (e.g. minoxidil, ketoconazole, selenium sulfide lotion) on scalp within 2 months before inclusion.
- Volunteer who changed her routine shampoo within 2 weeks before inclusion.
- Volunteer who has conditions considered by the Investigator as sound reasons for disqualification from enrolment into the study, because it might put the individual at significant risk, confound study results or interfere with the individual's participation.
- Volunteer who declares to be deprived of freedom by administrative or legal decision.
- Volunteer who cannot be contacted by phone in case of emergency.
- Volunteer having participated within 30 days before inclusion or currently participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decoding the Biological Mechanisms of Itchy Scalp
This is a single-center, cross-sectional, observational clinical study to investigate the clinical attributes and lipidomic signatures of itchy scalp with and without dandruff, aiming to validate the biological distinctiveness of pure scalp pruritus. A total of 132 female participants were enrolled and allocated to three cohorts (44 participants each) based on scalp pruritus and dandruff status. Clinical scoring, instrumental biophysical measurements, self-assessment questionnaires, and lipidomic signatures were analyzed and compared across groups.
- Conditions
- Itchy Scalp, Pruritus, Dandruff
- Medical subject headings
- Pruritus, Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Health control | Healthy volunteers with normal scalp (Pruritus VAS = 0, Adherent Dandruff Score ≤ 0.5). | |
| Group 2: Itchy Scalp with Dandruff | Volunteers with scalp pruritus (Pruritus VAS 4-8) and adherent dandruff (Dandruff Score 2-4). | |
| Group 3: Pure itchy scalp (without dandruff) | Volunteers with scalp pruritus (Pruritus VAS 4-8) and no/minimal dandruff (Dandruff Score ≤ 0.5). |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-coverage targeted lipidomics
Targeted lipidomics using membrane filter samples on scalp
Measured: Day 1 (Single assessment at baseline)
Secondary outcomes (5)
Clinical scalp scoring
Dermatologist-assessed erythema (0: none to 5: severe), greasiness (0: none to 3: severe), dryness (0: none to 9: severe), and clinical scalp type classification (dry, normal, greasy, or mixed).
Measured: Day 1 (Single assessment at baseline)
Transepidermal Water Loss (TEWL)
Evaluated on scalp sites using Tewameter® TM Nano (Courage + Khazaka electronic GmbH), expressed in g/h/m².
Measured: Day 1 (Single assessment at baseline)
Scalp hydration
Stratum corneum hydration level measured using DermaLab Hydration Pin Probe (Cortex Technology), expressed in arbitrary units (AU).
Measured: Day 1 (Single assessment at baseline)
Scalp sebum level
Sebum excretion level measured using Sebumeter® SM815 (Courage + Khazaka electronic GmbH), expressed in µg/cm².
Measured: Day 1 (Single assessment at baseline)
Scalp surface pH
Measured using Skin-pH-Meter PH905 (Courage + Khazaka electronic GmbH).
Measured: Day 1 (Single assessment at baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start28 Apr 2025
- Primary completion3 Jun 2025
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Itchy ScalpStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805031
- Sponsor's protocol ID
- ACR_DISK_25-00954
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding the Biological Mechanisms of Itchy Scalp
- ClinicalTrials.gov ID
- NCT07805031
- Acronym / sponsor ID
- ACR_DISK_25-00954
- Conditions
- Itchy Scalp, Pruritus, Dandruff
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 4 Sep 2026 (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 is a single-center, cross-sectional, observational clinical study to investigate the clinical attributes and lipidomic signatures of itchy scalp with and without dandruff, aiming to validate the biological distinctiveness of pure scalp pruritus. A total of 132 female participants were enrolled and allocated to three cohorts (44 participants each) based on scalp pruritus and dandruff status. Clinical scoring, instrumental biophysical measurements, self-assessment questionnaires, and lipidomic signatures were analyzed and compared across groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Health control | – | –Healthy volunteers with normal scalp (Pruritus VAS = 0, Adherent Dandruff Score ≤ 0.5). |
| Group 2: Itchy Scalp with Dandruff | – | –Volunteers with scalp pruritus (Pruritus VAS 4-8) and adherent dandruff (Dandruff Score 2-4). |
| Group 3: Pure itchy scalp (without dandruff) | – | –Volunteers with scalp pruritus (Pruritus VAS 4-8) and no/minimal dandruff (Dandruff Score ≤ 0.5). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chinese female volunteers aged 18 to 50 residing in Shanghai, China, recruited from the clinical testing center. The study population comprises healthy individuals with normal scalp conditions as well as individuals presenting with scalp pruritus with or without dandruff, stratified into three distinct cohorts based on pruritus VAS scores and adherent dandruff photographic scales (DFS).
Key inclusion criteria (13 listed)
- Female volunteer from 18 to 50 years old, in good general health (physical, mental, and social well-being) according to volunteer self-declaration and investigator's opinion.
- Female of childbearing potential who is not sexually active, or who is using an effective contraceptive method for at least one month before the beginning of the study and throughout the study.
- Female of childbearing potential willing to undergo urine pregnancy test.
- Volunteer has the life habit of washing hair twice to 7 times every week.
- Volunteer has scalp conditions based on group:
Key exclusion criteria (14 listed)
- Volunteer who is pregnant or lactating or who is planning to become pregnant during the study.
- Menopausal female (with absence of menstruations for less than one year) or post-menopausal female (with absence of menstruations for more than one year).
- Volunteer who has hair treatments including hair coloration, bleaching or perm within 3 months before inclusion.
- Volunteer who has skin cancer, severe autoimmune skin diseases or other moderate or severe skin diseases.
- Volunteer who has Seborrheic dermatitis, psoriasis, scalp pityriasis, tinea capitis, atopic dermatitis, folliculitis, alopecia or other skin disorders might interfere the assessment on scalp or calves determined by the dermatologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
High-coverage targeted lipidomics
Time frame: Day 1 (Single assessment at baseline)
Targeted lipidomics using membrane filter samples on scalp
5 secondary outcomes
Clinical scalp scoring
Time frame: Day 1 (Single assessment at baseline)
Transepidermal Water Loss (TEWL)
Time frame: Day 1 (Single assessment at baseline)
Scalp hydration
Time frame: Day 1 (Single assessment at baseline)
Scalp sebum level
Time frame: Day 1 (Single assessment at baseline)
Scalp surface pH
Time frame: Day 1 (Single assessment at baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Itchy Scalp and Pruritus, run by L'Oreal at 1 site in China.
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 13 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
High-coverage targeted lipidomics (time frame: Day 1 (Single assessment at baseline)). 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 Sep 2026.