NCT06052241

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

September 18, 2023

Last Update Submit

October 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Total Scalp Photographic Index (SPI) score

    week 8

  • Total Scalp Photographic Index (SPI) score

    week 12

  • subjective improvement in scalp conditions

    week 4

  • participant's satisfaction

    week 4

Study Arms (2)

Post-treatment

ACTIVE COMPARATOR

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

Pre-treatment

NO INTERVENTION

Interventions

shampoos and scalp serums personalized according to their SPI-AI-defined scalp types

Post-treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

MeSH Terms

Conditions

DandruffFolliculitis

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesScalp DermatosesHair Diseases

Study Officials

  • Jung-Im Na, M.D, Ph.D

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: prospective, single-center, pre-post comparative study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 25, 2023

Study Start

July 27, 2021

Primary Completion

January 7, 2022

Study Completion

February 7, 2022

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations