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CompletedNCT06052241Updated Oct 6, 2023

Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

An interventional study of shampoos and scalp serums in Dandruff and Folliculitis, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Dandruff
  • Folliculitis
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • No intervention
    Pre-treatment

Interventions

  • Drugshampoos and scalp serums

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

05

What researchers measure

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.

    Time frame: week 4

Secondary 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.

    Time frame: week 8

  2. 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.

    Time frame: week 12

  3. subjective improvement in scalp conditions

    proportion of participants achieving improvement in more than one item on the questionnaire

    Time frame: week 4

  4. participant's satisfaction

    proportion of participants satisfied with the products

    Time frame: week 4

06

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, 13620, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06052241
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Sponsor
First posted
Sep 25, 2023
Start date
Jul 27, 2021
Primary completion
Jan 7, 2022
Completion
Feb 7, 2022
Last update
Oct 6, 2023

Study contacts

Jung-Im Na, M.D, Ph.D
principal investigator · Seoul National University Bundang Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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