The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis

July 4, 2023 updated by: Integrative Skin Science and Research
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Acne vulgaris
Inflammatory and non-inflammatory lesion counts
Other: No Intervention
No Intervention
Other: Rosacea
Inflammatory lesion count
Other: No Intervention
No Intervention
Other: Melasma
Pigment intensity and distribution with use of Melasma Area Severity Index
Other: No Intervention
No Intervention
Other: Seborrheic Dermatitis
Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score
Other: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of image-based grading to clinical gradings for acne
Time Frame: Baseline
Number of inflammatory and noninflammatory lesions compared to clinical grading
Baseline
Correlation of image-based grading to clinical gradings for rosacea
Time Frame: Baseline
Inflammatory lesion count compared to clinical grading
Baseline
Correlation of image-based grading to clinical gradings for melasma
Time Frame: Baseline
Melasma area severity index image based grading compared to clinical grading
Baseline
Correlation of image-based grading to clinical gradings for seborrheic dermatitis
Time Frame: Baseline
Seborrheic dermatitis area severity index
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sebum excretion rate
Time Frame: Baseline
Measure of skin sebum via sebumeter
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Skin Science and Research

Collaborators

Codex Labs

Investigators

  • Principal Investigator: Raja Sivamani, MD, MS, AP, Integrative Skin and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Estimated)

December 6, 2023

Study Completion (Estimated)

April 6, 2024

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

July 4, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DERM_AI_IMAGES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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