AcneNCT05942248
The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
A study of Acne and Melasma, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 28 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with acne, rosacea, melasma or seborrheic dermatitis
Who cannot join
- Prisoners
- Adults unable to consent
- Artificial facial markings on day of facial photography (such as piercings and tattoos) that may interfere with imaging in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin and Research
Sacramento, California, 95815
Raja Sivamani, MD, MS, AP, 916-750-2463, research@integrativeskinresearch.com
About this study
The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.
Read the detailed description
The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to dermatologist based clinical severity grading.
- Conditions
- Acne, Melasma, Rosacea, Seborrheic Dermatitis
- Being tested
- No Intervention
- Keywords
- Artificial Intelligent, Skin
- Medical subject headings
- Acne Vulgaris, Melanosis, Rosacea, Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Acne vulgaris | Other | Inflammatory and non-inflammatory lesion counts Receives: Other: No Intervention |
| Rosacea | Other | Inflammatory lesion count Receives: Other: No Intervention |
| Melasma | Other | Pigment intensity and distribution with use of Melasma Area Severity Index Receives: Other: No Intervention |
| Seborrheic Dermatitis | Other | Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of image-based grading to clinical gradings for acne
Number of inflammatory and noninflammatory lesions compared to clinical grading
Measured: Baseline
Correlation of image-based grading to clinical gradings for rosacea
Inflammatory lesion count compared to clinical grading
Measured: Baseline
Correlation of image-based grading to clinical gradings for melasma
Melasma area severity index image based grading compared to clinical grading
Measured: Baseline
Correlation of image-based grading to clinical gradings for seborrheic dermatitis
Seborrheic dermatitis area severity index
Measured: Baseline
Secondary outcomes (1)
Sebum excretion rate
Measure of skin sebum via sebumeter
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start6 Jun 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Codex Labs
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD, MS, AP, Principal investigator, Integrative Skin and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942248
- Sponsor's protocol ID
- DERM_AI_IMAGES
- Status last verified
- Aug 2024
- First submitted
- 14 Jun 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT05942248
- Acronym / sponsor ID
- DERM_AI_IMAGES
- Conditions
- Acne, Melasma, Rosacea, Seborrheic Dermatitis
- Keywords
- Artificial Intelligent, Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Codex Labs
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 12 Jul 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 study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to expert based clinical severity grading.
Detailed description
The study is conducted to determine if image-based computer grading can of acne, melasma, rosacea and seborrheic dermatitis correlate well to dermatologist based clinical severity grading.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acne vulgaris | Other | Other: No InterventionInflammatory and non-inflammatory lesion counts |
| Rosacea | Other | Other: No InterventionInflammatory lesion count |
| Melasma | Other | Other: No InterventionPigment intensity and distribution with use of Melasma Area Severity Index |
| Seborrheic Dermatitis | Other | Other: No InterventionGrading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with acne, rosacea, melasma or seborrheic dermatitis
Key exclusion criteria (3 listed)
- Prisoners
- Adults unable to consent
- Artificial facial markings on day of facial photography (such as piercings and tattoos) that may interfere with imaging in the opinion of the investigator
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Acne vulgaris, Melasma, Rosacea, Seborrheic Dermatitis |
Primary outcome
Correlation of image-based grading to clinical gradings for acne
Time frame: Baseline
Number of inflammatory and noninflammatory lesions compared to clinical grading
Correlation of image-based grading to clinical gradings for rosacea
Time frame: Baseline
Inflammatory lesion count compared to clinical grading
Correlation of image-based grading to clinical gradings for melasma
Time frame: Baseline
Melasma area severity index image based grading compared to clinical grading
Correlation of image-based grading to clinical gradings for seborrheic dermatitis
Time frame: Baseline
Seborrheic dermatitis area severity index
1 secondary outcome
Sebum excretion rate
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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.
Raja Sivamani, MD, MS, AP principal investigator
Integrative Skin and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acne and Melasma, run by Integrative Skin Science and Research at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raja Sivamani, MD, MS, AP (916-750-2463, research@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of image-based grading to clinical gradings for acne (time frame: Baseline). The study lists 4 primary outcomes in all. 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 27 Aug 2024.