NCT05942248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

June 14, 2023

Last Update Submit

August 26, 2024

Conditions

AcneMelasmaRosaceaSeborrheic Dermatitis

Keywords

Artificial IntelligentSkin

Outcome Measures

Primary Outcomes (4)

  • Correlation of image-based grading to clinical gradings for acne

    Number of inflammatory and noninflammatory lesions compared to clinical grading

    Baseline

  • Correlation of image-based grading to clinical gradings for rosacea

    Inflammatory lesion count compared to clinical grading

    Baseline

  • Correlation of image-based grading to clinical gradings for melasma

    Melasma area severity index image based grading compared to clinical grading

    Baseline

  • Correlation of image-based grading to clinical gradings for seborrheic dermatitis

    Seborrheic dermatitis area severity index

    Baseline

Secondary Outcomes (1)

  • Sebum excretion rate

    Baseline

Study Arms (4)

Acne vulgaris

OTHER

Inflammatory and non-inflammatory lesion counts

Other: No Intervention

Rosacea

OTHER

Inflammatory lesion count

Other: No Intervention

Melasma

OTHER

Pigment intensity and distribution with use of Melasma Area Severity Index

Other: No Intervention

Seborrheic Dermatitis

OTHER

Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

Acne vulgarisMelasmaRosaceaSeborrheic Dermatitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with acne, rosacea, melasma or seborrheic dermatitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin and Research

Sacramento, California, 95815, United States

RECRUITING

MeSH Terms

Conditions

Acne VulgarisMelanosisRosaceaDermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesHyperpigmentationPigmentation DisordersDermatitisSkin Diseases, EczematousSkin Diseases, Papulosquamous

Study Officials

  • Raja Sivamani, MD, MS, AP

    Integrative Skin and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raja Sivamani, MD, MS, AP

CONTACT

916-750-2463research@integrativeskinresearch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 12, 2023

Study Start

June 6, 2023

Primary Completion

January 31, 2025

Study Completion

February 28, 2025

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)