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Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

Primary Purpose

Dandruff, Folliculitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
shampoos and scalp serums
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dandruff

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy adults aged >19 years presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple) Exclusion Criteria: presence of active infectious scalp diseases history of treatment with topical or systemic steroids, oral immunosuppressants, topical or systemic antibiotics, or antifungal agents that could affect the scalp conditions, within 4 weeks prior to the baseline difficulty understanding or following the protocol

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Post-treatment

Pre-treatment

Arm Description

After treatment using shampoo and scalp serum personalized according to their Scalp Photographic Index Artificial Intelligence (SPI-AI)-defined scalp types

Outcomes

Primary Outcome Measures

Total Scalp Photographic Index (SPI) score
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.

Secondary Outcome Measures

Total Scalp Photographic Index (SPI) score
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.
Total Scalp Photographic Index (SPI) score
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.
subjective improvement in scalp conditions
proportion of participants achieving improvement in more than one item on the questionnaire
participant's satisfaction
proportion of participants satisfied with the products

Full Information

First Posted
September 18, 2023
Last Updated
October 4, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06052241
Brief Title
Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics
Official Title
Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics: Efficacy Results
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigators aimed to evaluate whether they can be improved by an AI-based personalized prescription of scalp cosmetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dandruff, Folliculitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
prospective, single-center, pre-post comparative study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-treatment
Arm Type
Active Comparator
Arm Description
After treatment using shampoo and scalp serum personalized according to their Scalp Photographic Index Artificial Intelligence (SPI-AI)-defined scalp types
Arm Title
Pre-treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
shampoos and scalp serums
Intervention Description
shampoos and scalp serums personalized according to their SPI-AI-defined scalp types
Primary Outcome Measure Information:
Title
Total Scalp Photographic Index (SPI) score
Description
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Total Scalp Photographic Index (SPI) score
Description
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.
Time Frame
week 8
Title
Total Scalp Photographic Index (SPI) score
Description
Change from the baseline in the total SPI score. The total SPI score (0-75 points) is the sum of the SPI score of five areas: vertex, anterior, posterior, right, and left. Higher SPI scores mean a worse condition, and larger changes from baseline in the total SPI score mean a better outcome.
Time Frame
week 12
Title
subjective improvement in scalp conditions
Description
proportion of participants achieving improvement in more than one item on the questionnaire
Time Frame
week 4
Title
participant's satisfaction
Description
proportion of participants satisfied with the products
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adults aged >19 years presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple) Exclusion Criteria: presence of active infectious scalp diseases history of treatment with topical or systemic steroids, oral immunosuppressants, topical or systemic antibiotics, or antifungal agents that could affect the scalp conditions, within 4 weeks prior to the baseline difficulty understanding or following the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Im Na, M.D, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

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