Impact of Sex Hormones on Human Skin Immunity in Health and Hidradenitis Suppurativa (SIAP)

NCT07291193 | Not Yet Recruiting

• 2 other identifiers: 2024-0722025-A00923-46
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sex hormones are major regulators of skin immunity. Pregnancy represents a unique physiological state of profound hormonal remodeling. In late pregnancy, maternal levels of estrogens, progesterone, and other hormones increase dramatically, offering an unparalleled model to study the impact of sex hormones on skin immunity. Hidradenitis suppurativa (HS) provides a clinically relevant model to examine how sex hormones modulate skin inflammation.

Conditions

Skin Immunity

Keywords

Pregnancy; Maternal Immunity; Skin; Hormones; Single Cell; Spatial-Omics

Outcome Measures

Primary Outcomes (1)

• Evaluate the impact of sex hormones and pregnancy on skin immunity by comparing immune cell populations in different populations (pregnant women, non-pregnant women, and men) with or without hidradenitis suppurativa.

  Percentage of key skin immune cells (ILC2, dendritic cells, Langerhans cells), according to sex, pregnancy, and pathological context (healthy vs HS).

  4 years

Secondary Outcomes (3)

• Defining the spatial organisation of skin cells in order to assess how pregnancy remodels cutaneous immune responses in health and HS inflammation.

  4 years

• Exploring how sex hormones, which are massively increased during pregnancy, and circulating immune profiling impact skin function and immunity.

  4 years

• Revealing the influence of the skin microbiota on the host immune system adapting to pregnancy in healthy and HS conditions.

  4 years

Study Arms (6)

Healthy - Pregnant women

Adult woman, not affected by Hidradenitis Suppurativa, pregnant in her third trimester

Procedure: Blood sample, skin microbiota and biopsy

Healthy - Non-pregnant women

Adult woman, not affected by Hidradenitis Suppurativa

Procedure: Blood sample, skin microbiota and biopsy

Healthy - Men

Adult men, not affected by Hidradenitis Suppurativa

Procedure: Blood sample, skin microbiota and biopsy

Hidradenitis suppurativa - Pregnant women

Adult woman, affected by Hidradenitis Suppurativa, pregnant in her third trimester

Procedure: Blood sample, skin microbiota and biopsy

Hidradenitis suppurativa - Non-pregnant women

Adult woman, affected by Hidradenitis Suppurativa

Procedure: Blood sample, skin microbiota and biopsy

Hidradenitis suppurativa - Men

Adult men, affected by Hidradenitis Suppurativa

Procedure: Blood sample, skin microbiota and biopsy

Interventions

Blood sample, skin microbiota and biopsy PROCEDURE

Blood sample (maximum 40mL) Skin microbiota (collection of cells from the skin surface using a swab (non-invasive) Skin biopsy, in hormone-dependent areas and/or in a non-hormone-dependent areas

Healthy - Men; Healthy - Non-pregnant women; Healthy - Pregnant women; Hidradenitis suppurativa - Men; Hidradenitis suppurativa - Non-pregnant women; Hidradenitis suppurativa - Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

As part of this study, adults (pregnant women, non-pregnant women, and men), healthy (not affected by HS) and affected by HS, will be recruited.

You may qualify if:

• Common criteria :
• Subject\>18 years and \<45 years,
• Written informed consent of the subject,
• Subject affiliated to the Assurance Maladie (French Health System) except Aide Médicale d'Etat (French State Medical Aid),
• Subject agrees that genomic analyses may be carried out on the samples
• Specific criteria :
• For pregnant women:Third trimester of pregnancy (between 29-37 weeks of amenorrhea).
• For HS subjects: Subject with hidradenitis suppurativa lesions at the sampling sites.

You may not qualify if:

• Common criteria :
• Subject immunocompromised,
• Subject under legal protection (guardianship or curatorship),
• Subject is unable to provide informed consent and to comply with the study requirements due to geographical, social, or psychiatric reasons,
• Subject in other research whose procedures may influence the immune system,
• Contraindication to any of medications listed in section 5.1 (antiseptic and local anesthetic used for biopsy(ies)),
• Subject whose health condition does not permit participation in study procedures.
• Specific criteria :
• For no HS subjects : Scarred skin at the biopsy site, Subject with pre-existing and/or still active inflammatory skin conditions, Subject experiencing early menopause (women) or andropause (men).

Sponsors & Collaborators

• Institut Pasteur: lead

MeSH Terms

Interventions

Blood Specimen Collection; Skin Microbiome; Biopsy

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Bénédicte OULES, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clarisse GANIER, PhD

CONTACT

0145688767; clarisse.ganier@pasteur.fr

Julia ABAD

CONTACT

0140669760; julia.abad@pasteur.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: January 9, 2026

Record last verified: 2025-11