- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459023
Changes in Scalp Condition After Using a Moisturizer: a Prospective Clinical Trial Using Artificial Intelligence (scalp)
Changes in Scalp Condition After Using a Moisturizer Containing Celastrol and Cichorium Intybus Root Extract: a Prospective Clinical Trial Using Artificial Intelligence
The goal of this clinical trial is to evaluate whether a scalp moisturizer containing celastrol and Cichorium intybus root extract can improve scalp condition in adults aged 19 years or older who require scalp moisturization due to dryness, scaling, erythema, or dandruff. The main questions it aims to answer are:
Does once-daily application of the study moisturizer improve scalp condition from baseline to week 4, as assessed by SPI-AI (Scalp Photographic Index-Artificial Intelligence)?
Does the moisturizer improve scalp biophysical parameters (erythema index, stratum corneum hydration, and transepidermal water loss) and patient-reported symptom severity over the 4-week treatment period?
Participants will:
Apply the study moisturizer once daily at bedtime to dry scalp for 4 weeks and rinse it off the following morning using their usual shampoo.
Attend study visits at baseline (week 0), week 2, and week 4 for scalp imaging, biophysical measurements, symptom questionnaires, adherence assessment, and safety monitoring.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kyeonggi
-
Seongnam-si, Kyeonggi, South Korea
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Age ≥19 years
- Presence of scalp erythema, dryness, scaling, or dandruff requiring scalp moisturization
Exclusion Criteria:
- Active infectious scalp dermatoses
- Use of topical or systemic therapies affecting scalp status within 4 weeks prior to enrollment or during the study period
- Inability to comply with the study protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Moisturizer
participants applies the moisturizer once daily to the entire scalp at bedtime
|
participants applied the moisturizer once daily to the entire scalp at bedtime
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SPI-AI
Time Frame: 4week
|
Scalp Photographic Index with artificial intelligence
|
4week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SPI-AI
Time Frame: 2week
|
Scalp Photographic Index with artificial intelligence
|
2week
|
|
Biophysical parameter
Time Frame: 2week
|
erythema index (arbitrary unit)
|
2week
|
|
Biophysical parameter
Time Frame: 4week
|
erythema index (arbitrary unit)
|
4week
|
|
Biophysical parameter
Time Frame: 2 week
|
corneometer (arbitrary unit)
|
2 week
|
|
Biophysical parameter
Time Frame: 4 week
|
corneometer (arbitrary unit)
|
4 week
|
|
Biophysical parameter
Time Frame: 2 week
|
transepidermal water loss (g/m2/h)
|
2 week
|
|
Biophysical parameter
Time Frame: 4 week
|
transepidermal water loss (g/m2/h)
|
4 week
|
|
Patient-reported outcome
Time Frame: 2 week
|
visual analog scale (0-10) : higher is worse
|
2 week
|
|
Patient-reported outcome
Time Frame: 4 week
|
visual analog scale (0-10) : higher is worse
|
4 week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2504-964-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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