Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06052241
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.4
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dandruff; Folliculitis	Drug: shampoos and scalp serums	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: prospective, single-center, pre-post comparative studyprospective, single-center, pre-post comparative study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics: Efficacy Results
• Actual Study Start Date: Jul 27, 2021
• Actual Primary Completion Date: Jan 7, 2022
• Actual Study Completion Date: Feb 7, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. total SPI score [week 4]

   change from the baseline in the total SPI score

Secondary Outcome Measures

1. total SPI score [week 8]

   change from the baseline in the total SPI score

2. total SPI score [week 12]

   change from the baseline in the total SPI score

3. subjective improvement in scalp conditions [week 4]

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

4. participant's satisfaction [week 4]

   proportion of participants satisfied with the products

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of	13620

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT06052241
• Other Study ID Numbers: B-2107-697-301
• First Posted: Sep 25, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Folliculitis; Dandruff

Study Results

No Results Posted as of Sep 25, 2023