ClinicalTrials.gg
RecruitingNCT05942248Updated Aug 27, 2024

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

An interventional study of No Intervention in Acne, Melasma and Rosacea, sponsored by Integrative Skin Science and Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne
  • Melasma
  • Rosacea
  • Seborrheic Dermatitis

Keywords

  • Artificial Intelligent
  • Skin
03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's planned enrollment of 150 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with acne, rosacea, melasma or seborrheic dermatitis

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Acne vulgaris

    Inflammatory and non-inflammatory lesion counts

    Other: No Intervention

  • Other
    Rosacea

    Inflammatory lesion count

    Other: No Intervention

  • Other
    Melasma

    Pigment intensity and distribution with use of Melasma Area Severity Index

    Other: No Intervention

  • Other
    Seborrheic Dermatitis

    Grading of seborrheic dermatitis with Seborrheic Dermatitis Area Severity Index score

    Other: No Intervention

Interventions

  • OtherNo Intervention

    No Intervention

06

What researchers measure

Primary outcomes

  1. Correlation of image-based grading to clinical gradings for acne

    Number of inflammatory and noninflammatory lesions compared to clinical grading

    Time frame: Baseline

  2. Correlation of image-based grading to clinical gradings for rosacea

    Inflammatory lesion count compared to clinical grading

    Time frame: Baseline

  3. Correlation of image-based grading to clinical gradings for melasma

    Melasma area severity index image based grading compared to clinical grading

    Time frame: Baseline

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

    Seborrheic dermatitis area severity index

    Time frame: Baseline

Secondary outcomes

  1. Sebum excretion rate

    Measure of skin sebum via sebumeter

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Jan 2025, 19 months after the start.

Of 62 industry-sponsored interventional studies with no phase under Acne Vulgaris, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's planned 19 months is above that.

Counting every sponsor, half of 120 studies reached it within 9 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2023
First posted
Jul 12, 2023
StartActual
Jun 6, 2023
Primary completionEst.
Jan 31, 2025
CompletionEst.
Feb 28, 2025
Last update
Aug 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05942248
Collaborators
Codex Labs
Responsible party
Sponsor
First posted
Jul 12, 2023
Start date
Jun 6, 2023
Primary completion
Jan 31, 2025 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Aug 27, 2024

Study contacts

Raja Sivamani, MD, MS, AP
Contact
research@integrativeskinresearch.com
916-750-2463
Raja Sivamani, MD, MS, AP
principal investigator · Integrative Skin and Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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