The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
Primary Purpose
Acne, Melasma, Rosacea
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Intervention
Sponsored by
About this trial
This is an interventional other trial for Acne focused on measuring Artificial Intelligent, Skin
Eligibility Criteria
Inclusion Criteria: Adults with acne, rosacea, melasma or seborrheic dermatitis Exclusion Criteria: 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
Sites / Locations
- Integrative Skin and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Acne vulgaris
Rosacea
Melasma
Seborrheic Dermatitis
Arm Description
Inflammatory and non-inflammatory lesion counts
Inflammatory lesion count
Pigment intensity and distribution with use of Melasma Area Severity Index
Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score
Outcomes
Primary Outcome Measures
Correlation of image-based grading to clinical gradings for acne
Number of inflammatory and noninflammatory lesions compared to clinical grading
Correlation of image-based grading to clinical gradings for rosacea
Inflammatory lesion count compared to clinical grading
Correlation of image-based grading to clinical gradings for melasma
Melasma area severity index image based grading compared to clinical grading
Correlation of image-based grading to clinical gradings for seborrheic dermatitis
Seborrheic dermatitis area severity index
Secondary Outcome Measures
Sebum excretion rate
Measure of skin sebum via sebumeter
Full Information
NCT ID
NCT05942248
First Posted
June 14, 2023
Last Updated
July 4, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
Codex Labs
1. Study Identification
Unique Protocol Identification Number
NCT05942248
Brief Title
The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
Official Title
The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2023 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
April 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
Codex Labs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Melasma, Rosacea, Seborrheic Dermatitis
Keywords
Artificial Intelligent, Skin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acne vulgaris
Arm Type
Other
Arm Description
Inflammatory and non-inflammatory lesion counts
Arm Title
Rosacea
Arm Type
Other
Arm Description
Inflammatory lesion count
Arm Title
Melasma
Arm Type
Other
Arm Description
Pigment intensity and distribution with use of Melasma Area Severity Index
Arm Title
Seborrheic Dermatitis
Arm Type
Other
Arm Description
Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
Correlation of image-based grading to clinical gradings for acne
Description
Number of inflammatory and noninflammatory lesions compared to clinical grading
Time Frame
Baseline
Title
Correlation of image-based grading to clinical gradings for rosacea
Description
Inflammatory lesion count compared to clinical grading
Time Frame
Baseline
Title
Correlation of image-based grading to clinical gradings for melasma
Description
Melasma area severity index image based grading compared to clinical grading
Time Frame
Baseline
Title
Correlation of image-based grading to clinical gradings for seborrheic dermatitis
Description
Seborrheic dermatitis area severity index
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Sebum excretion rate
Description
Measure of skin sebum via sebumeter
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with acne, rosacea, melasma or seborrheic dermatitis
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raja Sivamani, MD, MS, AP
Phone
916-750-2463
Email
research@integrativeskinresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD, MS, AP
Organizational Affiliation
Integrative Skin and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD, MS, AP
Phone
916-750-2463
Email
research@integrativeskinresearch.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis
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