SGS Standards and Technology Co., Ltd
Shanghai, China
NCT Number: NCT07805031
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
Female
Observational
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Time frame: Day 1 (Single assessment at baseline)
Targeted lipidomics using membrane filter samples on scalp
Time frame: Day 1 (Single assessment at baseline)
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)
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)
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)
Sebum excretion level measured using Sebumeter® SM815 (Courage + Khazaka electronic GmbH), expressed in µg/cm².
Time frame: Day 1 (Single assessment at baseline)
Measured using Skin-pH-Meter PH905 (Courage + Khazaka electronic GmbH).
L'Oreal
Industry
Decoding the Biological Mechanisms of Itchy Scalp
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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