Itchy Scalp Biomarkers Exploration

NCT07805031 | Active Not Recruiting

• 1 other identifier: ACR_DISK_25-00954
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Itchy Scalp; Pruritus; Dandruff

Outcome Measures

Primary Outcomes (1)

• High-coverage targeted lipidomics

  Targeted lipidomics using membrane filter samples on scalp

  Day 1 (Single assessment at baseline)

Secondary Outcomes (5)

• Clinical scalp scoring

  Day 1 (Single assessment at baseline)

• Transepidermal Water Loss (TEWL)

  Day 1 (Single assessment at baseline)

• Scalp hydration

  Day 1 (Single assessment at baseline)

• Scalp sebum level

  Day 1 (Single assessment at baseline)

• Scalp surface pH

  Day 1 (Single assessment at baseline)

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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 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).
• Volunteer who has active gastrointestinal (GI) bleeding or history of heart or vascular disease.
• 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.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

SGS Standards and Technology Co., Ltd

Shanghai, China

Location

MeSH Terms

Conditions

Pruritus; Dandruff

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dermatitis; Scalp Dermatoses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: April 28, 2025
• Primary Completion: June 3, 2025
• Study Completion: September 15, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)