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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
Integrative Skin Science and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acne focused on measuring Artificial Intelligent, Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 14, 2023
Last Updated
July 4, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
Codex Labs
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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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