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Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers

I

Innovaderm Research

Status

Enrolling

Conditions

Atopic Dermatitis
Acne
Chronic Hand Eczema
Plaque Psoriasis
Palmoplantar Pustulosis
Hidradenitis Suppurativa

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT05994976
INNO-5034

Details and patient eligibility

About

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

Full description

This study is being conducted to collect samples from subjects with various skin conditions as well as healthy volunteers. Collected samples may be used for different analyses including, but not limited to, biomarker and gene expression analyses.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

All subjects:

  1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.

  2. Subject must be willing to comply with all study procedures and must be available for the duration of the study.

    Healthy volunteers:

  3. Male or female subject aged 18 years or older, at the time of consent.

  4. Subject is in good general health, according to the investigator's judgment.

    Subjects with Acne:

  5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.

    Subjects with AD:

  6. Male or female subject aged 18 years or older, at the time of consent.

  7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.

    Subjects with CHE:

  8. Male or female subject aged 18 years or older, at the time of consent.

  9. 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:

  10. Male or female subject aged 18 years or older, at the time of consent.

  11. Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before screening as determined by the investigator through subject interview and/or review of the medical history.

    Subjects with PPP:

  12. Male or female subject aged 18 years or older at the time of consent.

  13. Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject's physician, or directly from the subject).

    Subjects with psoriasis:

  14. Male or female subject aged 18 years or older, at the time of consent.

Exclusion criteria

All subjects:

  1. Subject is a female who is pregnant or who is planning to become pregnant during the study.
  2. 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.

Trial design

500 participants in 7 patient groups

Healthy volunteers
Description:
Healthy adults
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
Acne
Description:
Adult subjects aged 18 to 45 years old with acne
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
AD
Description:
Adult subjects with Atopic Dermatitis (AD)
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
CHE
Description:
Adult subjects with Chronic Hand Eczema (CHE)
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
HS
Description:
Adult subjects with Hidradenitis suppurativa (HS)
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
PPP
Description:
Adult subjects with Palmoplantar pustulosis (PPP)
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection
Psoriasis
Description:
Adult subjects with Psoriasis
Treatment:
Procedure: Blood samples collection
Procedure: Stool samples collection
Procedure: Oral samples collection
Procedure: Drainage fluid samples collection
Procedure: Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)
Procedure: Skin surface material samples
Procedure: Hair samples collection

Trial contacts and locations

1

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Central trial contact

Julie Bedoucha, MSc

Data sourced from clinicaltrials.gov

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