NCT05994976

Brief Summary

The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Oct 2023

Longer than P75 for all trials

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 Progress53%
Oct 2023Aug 2028

First Submitted

Initial submission to the registry

August 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

August 9, 2023

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Untargeted biomarker approach with gene expression profile of skin samples

    Day 1

  • Exploratory biomarker and gene expression analyses.

    Day 1

Study Arms (7)

Healthy volunteers

Healthy adults

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

Acne

Adult subjects aged 18 to 45 years old with acne

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

AD

Adult subjects with Atopic Dermatitis (AD)

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

CHE

Adult subjects with Chronic Hand Eczema (CHE)

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

HS

Adult subjects with Hidradenitis suppurativa (HS)

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

PPP

Adult subjects with Palmoplantar pustulosis (PPP)

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

Psoriasis

Adult subjects with Psoriasis

Procedure: Blood samples collectionProcedure: Oral samples collectionProcedure: Hair samples collectionProcedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)Procedure: Skin surface material samplesProcedure: Drainage fluid samples collectionProcedure: Stool samples collection

Interventions

biomarkers and optional genetic analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

biomarkers analysis

ADAcneCHEHSHealthy volunteersPPPPsoriasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 200 healthy volunteers and approximately 300 subjects with acne, atopic dermatitis (AD), chronic hand eczema (CHE), hidradenitis suppurativa (HS), palmoplantar pustulosis (PPP), and/or psoriasis will be included in this study.

You may qualify if:

  • All subjects:
  • Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
  • Subject must be willing to comply with all study procedures and must be available for the duration of the study.
  • Healthy volunteers:
  • Male or female subject aged 18 years or older, at the time of consent.
  • Subject is in good general health, according to the investigator's judgment.
  • Subjects with Acne:
  • Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.
  • Subjects with AD:
  • Male or female subject aged 18 years or older, at the time of consent.
  • Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
  • Subjects with CHE:
  • Male or female subject aged 18 years or older, at the time of consent.
  • Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject).
  • Subjects with HS:
  • +7 more criteria

You may not qualify if:

  • All subjects:
  • Subject is a female who is pregnant or who is planning to become pregnant during the study.
  • Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, saliva, skin sample, lipid, sebum, microbiome, microorganism, hair, draining fluid

MeSH Terms

Conditions

Acne VulgarisDermatitis, AtopicHidradenitis SuppurativaPsoriasis

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationHidradenitisSweat Gland DiseasesSkin Diseases, Papulosquamous

Study Officials

  • Robert Bissonnette, MD

    Innovaderm Research Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Bedoucha, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 16, 2023

Study Start

October 17, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations