DandruffNCT06052241
Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics
A study of Dandruff and Folliculitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate whether they can be improved by an AI-based personalized prescription of scalp cosmetics. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dandruff, Folliculitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2021to 7 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults aged >19 years
- presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: 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.
- Conditions
- Dandruff, Folliculitis
- Being tested
- shampoos and scalp serums
- Medical subject headings
- Dandruff, Folliculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shampoos and scalp serumsDrug
shampoos and scalp serums personalized according to their SPI-AI-defined scalp types
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: shampoos and scalp serums |
| Pre-treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4
Secondary outcomes (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.
Measured: 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.
Measured: week 12
subjective improvement in scalp conditions
proportion of participants achieving improvement in more than one item on the questionnaire
Measured: week 4
participant's satisfaction
proportion of participants satisfied with the products
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start27 Jul 2021
- Primary completion7 Jan 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DandruffStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- prospective, single-center, pre-post comparative study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Im Na, M.D, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052241
- Sponsor's protocol ID
- B-2107-697-301
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Prescription of Personalized Scalp Cosmetics: Efficacy Results
- ClinicalTrials.gov ID
- NCT06052241
- Acronym / sponsor ID
- B-2107-697-301
- Conditions
- Dandruff, Folliculitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to evaluate whether they can be improved by an AI-based personalized prescription of scalp cosmetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, single-center, pre-post comparative study
| Arm | Type | Receives |
|---|---|---|
| Post-treatment | Active comparator | Drug: shampoos and scalp serumsAfter treatment using shampoo and scalp serum personalized according to their Scalp Photographic Index Artificial Intelligence (SPI-AI)-defined scalp types |
| Pre-treatment | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adults aged >19 years
- presence of scalp-related discomfort (such as itching, a sensation of heat, dandruff, excessive sebum, dryness, pain, or pimple)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shampoos and scalp serumsshampoos and scalp serums personalized according to their SPI-AI-defined scalp types | Drug | Post-treatment |
Primary outcome
Total Scalp Photographic Index (SPI) score
Time frame: week 4
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.
4 secondary outcomes
Total Scalp Photographic Index (SPI) score
Time frame: week 8
Total Scalp Photographic Index (SPI) score
Time frame: week 12
subjective improvement in scalp conditions
Time frame: week 4
participant's satisfaction
Time frame: week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Im Na, M.D, Ph.D principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dandruff and Folliculitis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Scalp Photographic Index (SPI) score (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.