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

Sponsor

Integrative Skin Science and Research (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05942248

Collaborator

Codex Labs (Other)

1,000

Enrollment

Location

Arms

Anticipated Duration (Months)

99.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Melasma Rosacea Seborrheic Dermatitis	Other: No Intervention	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 6, 2023

Anticipated Primary Completion Date :

Dec 6, 2023

Anticipated Study Completion Date :

Apr 6, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Correlation of image-based grading to clinical gradings for acne [Baseline]
Number of inflammatory and noninflammatory lesions compared to clinical grading
Correlation of image-based grading to clinical gradings for rosacea [Baseline]
Inflammatory lesion count compared to clinical grading
Correlation of image-based grading to clinical gradings for melasma [Baseline]
Melasma area severity index image based grading compared to clinical grading
Correlation of image-based grading to clinical gradings for seborrheic dermatitis [Baseline]
Seborrheic dermatitis area severity index

Secondary Outcome Measures

Sebum excretion rate [Baseline]
Measure of skin sebum via sebumeter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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