ClinicalTrials.gg
CompletedNCT07805031Updated Nov 5, 2026

Itchy Scalp Biomarkers Exploration

An observational study in Itchy Scalp, Pruritus and Dandruff, sponsored by L'Oreal. Completed at 1 site in China. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by L'Oreal · Observational

Updated Nov 5, 2026Now CompletedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
132
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Itchy Scalp
  • Pruritus
  • Dandruff

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03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's enrollment of 132 is close to the median of 128 across 48 observational studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

L'Oreal is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Female of who is not sexually active, or who is using an effective method for at least one month before the beginning of the study and throughout the study.
  3. Female of childbearing potential willing to undergo urine pregnancy test.
  4. Volunteer has the life habit of washing hair twice to 7 times every week.
  5. Volunteer has scalp conditions based on group:

    a. Group 1 i. Self-declared normal scalp without pruritus, score=0 on pruritus Visual Analog Scale (VAS).

    ii. Adherent dandruff score ≤0.5 based on Dandruff Photographic Scales (DFS) assessed by dermatologist.

    b. 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.

  6. Volunteer with Asian scalp.
  7. Volunteer living in Shanghai for at least one year.
  8. Volunteer willing and able to fulfil the study requirements and schedule.
  9. Volunteer informed about the study objectives and procedures, and able to understand them.
  10. Volunteer who has given written .

Exclusion criteria

Exclusion Criteria:

  1. Volunteer who is pregnant or lactating or who is planning to become pregnant during the study.
  2. Menopausal female (with absence of menstruations for less than one year) or female (with absence of menstruations for more than one year).
  3. Volunteer who has hair treatments including hair coloration, bleaching or perm within 3 months before inclusion.
  4. Volunteer who has skin cancer, severe skin diseases or other moderate or severe skin diseases.
  5. 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.
  6. 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).
  7. Volunteer who has active gastrointestinal (GI) bleeding or history of heart or vascular disease.
  8. 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.
  9. 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.
  10. Volunteer who changed her routine shampoo within 2 weeks before inclusion.
  11. 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.
  12. Volunteer who declares to be deprived of freedom by administrative or legal decision.
  13. Volunteer who cannot be contacted by phone in case of emergency.
  14. Volunteer having participated within 30 days before inclusion or currently participating in another clinical study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
132 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. High-coverage targeted lipidomics

    Targeted lipidomics using membrane filter samples on scalp

    Time frame: Day 1 (Single assessment at baseline)

Secondary outcomes

  1. 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).

    Time frame: Day 1 (Single assessment at baseline)

  2. Transepidermal Water Loss (TEWL)

    Evaluated on scalp sites using Tewameter® TM Nano (Courage + Khazaka electronic GmbH), expressed in g/h/m².

    Time frame: Day 1 (Single assessment at baseline)

  3. Scalp hydration

    Stratum corneum hydration level measured using DermaLab Hydration Pin Probe (Cortex Technology), expressed in arbitrary units (AU).

    Time frame: Day 1 (Single assessment at baseline)

  4. Scalp sebum level

    Sebum excretion level measured using Sebumeter® SM815 (Courage + Khazaka electronic GmbH), expressed in µg/cm².

    Time frame: Day 1 (Single assessment at baseline)

  5. Scalp surface pH

    Measured using Skin-pH-Meter PH905 (Courage + Khazaka electronic GmbH).

    Time frame: Day 1 (Single assessment at baseline)

07

Study locations

1 site
  • SGS Standards and Technology Co., Ltd
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2025 to primary completion in Jun 2025, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartActual
Apr 28, 2025
Primary completionActual
Jun 3, 2025
CompletionActual
Sep 15, 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07805031
Lead sponsor
L'Oreal
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Apr 28, 2025
Primary completion
Jun 3, 2025
Completion
Sep 15, 2026
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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