Impact of Sex Hormones on Human Skin Immunity in Health and Hidradenitis Suppurativa (SIAP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample, skin microbiota and biopsy.
- Who it may be relevant to
- Registry conditions: Skin Immunity. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Sex Hormones on Human Skin Immunity in Health and Hidradenitis Suppurativa
Overview
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.
Detailed description
Sex hormones are major regulators of skin immunity. Recent work from Belkaid's laboratory in mice demonstrated that testosterone negatively regulated skin innate lymphoid cells (ILC2), leading to a reduction in dendritic cell accumulation and decreased activation in males, along with reduced tissue immunity. These findings highlight that sex-related differences in skin immunity emerge primarily after sexual maturation, driven by fluctuating hormone levels. However, whether these mechanisms are conserved in humans remains unknown.
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. Understanding maternal skin immunity is of particular importance, as the maternal immune system must balance tolerance to the fetus with protection against pathogens. Perturbation in this balance can have lasting effects on both maternal and child health. Faced with the dramatic increase in inflammatory and autoimmune disorders affecting children globally, understanding maternal immunity is of fundamental importance.
Hidradenitis suppurativa (HS) provides a clinically relevant disease model to examine how sex hormones modulate skin inflammation. HS is a chronic inflammatory skin disease with strong sex dimorphism: it affects predominantly women (70%) in Europe but is often more severe in men. In women, HS severity varies with the menstrual cycle and is frequently altered during pregnancy, suggesting a hormonal component in disease modulation. Yet, the mechanisms linking sex hormones, pregnancy, and skin immune responses in HS remain unexplored.
By systematically comparing men, non-pregnant women, and pregnant women, in both health and HS, this study will map immune cell populations in the skin and determine how sex hormones; testosterone, estrogens, and progesterone; shape cutaneous immunity at steady state and during inflammation.
Interventions
- Procedure Blood sample, skin microbiota and biopsy
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
Primary outcome measures
- 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. [Time frame: 4 years]
Secondary outcome measures (3)
- Defining the spatial organisation of skin cells in order to assess how pregnancy remodels cutaneous immune responses in health and HS inflammation. [Time frame: 4 years]
- Exploring how sex hormones, which are massively increased during pregnancy, and circulating immune profiling impact skin function and immunity. [Time frame: 4 years]
- Revealing the influence of the skin microbiota on the host immune system adapting to pregnancy in healthy and HS conditions. [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07291193 · 2024-072 · 2025-A00923-46