Impact of Sex Hormones on Human Skin Immunity in Health and Hidradenitis Suppurativa (SIAP)
ConditionSkin Immunity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorInstitut Pasteur
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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,
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Blood sample, skin microbiota and biopsy
Procedure/SurgeryBlood 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
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Healthy - Pregnant women1 intervention
Group B: Healthy - Non-pregnant women1 intervention
Group C: Healthy - Men1 intervention
Group D: Hidradenitis suppurativa - Pregnant women1 intervention
Group E: Hidradenitis suppurativa - Non-pregnant women1 intervention
Group F: Hidradenitis suppurativa - Men1 intervention
Trial outcomes
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).
Time frame
4 yearsSecondary outcomes
1
Defining the spatial organisation of skin cells in order to assess how pregnancy remodels cutaneous immune responses in health and HS inflammation.
Immune cell mapping in healthy vs. inflamed skin biopsies across hormonal states (e.g. pregnancy).
Time frame
4 years2
Exploring how sex hormones, which are massively increased during pregnancy, and circulating immune profiling impact skin function and immunity.
Measurement of sex hormones and composition of PBMCs (Peripheral Blood Mononuclear Cells) in the blood of pregnant women and in controls (men and non-pregnant women).
Time frame
4 years3
Revealing the influence of the skin microbiota on the host immune system adapting to pregnancy in healthy and HS conditions.
Skin microbial metatranscriptomic profiling at the latest stage of pregnancy and in controls (men and non-pregnant women) in healthy and HS conditions.
Time frame
4 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: