Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics: Efficacy Results

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

Study Overview

• Status: Completed
• Conditions: Folliculitis; Dandruff
• Intervention / Treatment: Drug: shampoos and scalp serums

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. healthy adults aged >19 years
2. presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple)

Exclusion Criteria:

1. presence of active infectious scalp diseases
2. 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
3. difficulty understanding or following the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Post-treatment; After treatment using shampoo and scalp serum personalized according to their Scalp Photographic Index Artificial Intelligence (SPI-AI)-defined scalp types	Drug: shampoos and scalp serums; shampoos and scalp serums personalized according to their SPI-AI-defined scalp types
No Intervention: Pre-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective improvement in scalp conditions	proportion of participants achieving improvement in more than one item on the questionnaire	week 4
participant's satisfaction	proportion of participants satisfied with the products	week 4
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.	week 8
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.	week 12

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Jung-Im Na, M.D, Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): January 7, 2022
• Study Completion (Actual): February 7, 2022

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Hair Diseases; Scalp Dermatoses; Folliculitis; Dandruff
• Other Study ID Numbers: B-2107-697-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No