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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04352036
Other study ID # RC19_0418
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 4, 2022
Est. completion date February 20, 2030

Study information

Verified date January 2022
Source Nantes University Hospital
Contact Brigitte Dreno, PU-PH
Phone 0240083118
Email brigitte.dreno@wanadoo.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Our primary objective with this cohort will be to define the different phenotypes of acute hidrosadenitis, the characterization of which is essential to define suitable therapeutic approaches. Indeed, our recent data allow us to note that there would be different phenotypes of acute hidrosadenitis and therefore different pathologies inducing different follow-ups and care.


Recruitment information / eligibility

Status Recruiting
Enrollment 465
Est. completion date February 20, 2030
Est. primary completion date February 20, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient diagnosed with acute hidrosadenitis by a dermatologist - Patient agreeing to be part of the study Exclusion Criteria: - No affiliation to a social security scheme - Major under guardianship - Protected persons

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no interventional study
no interventional study

Locations

Country Name City State
France CHU Angers Angers
France Chru Brest Brest
France CHD Vendée La Roche Sur Yon
France CH La Rochelle La Rochelle
France CH Le Mans
France CH bretagne sud Lorient
France CHU de Nantes - Dermatologie Nantes
France Chr D'Orléans Orléans
France CHU Milétrie Poitiers
France Ch de Cornouaille Quimper
France CHU Pontchaillou Rennes
France Ch Saint-Brieuc Saint-Brieuc
France CHRU Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of the natural history and identification of the different clinical forms of acute hidrosadenitis history of the disease, classification of Hurley, Canoui-Poitrine and van der Zee and Jemec through study completion, an average of 3 years
Primary Prevalence of severe forms (grade II, III) Number of patients with severe disease (grades II and III) through study completion, an average of 3 years
Primary Definition of different phenotypes of acute hidrosadenitis patient history, Canoui-Poitrine and van der Zee and Jemec classification, blood and urine tests, imaging through study completion, an average of 3 years
Primary Identify the environmental factors associated with the chronicity of the disease socio-demographic data through study completion, an average of 3 years
Primary Identify the environmental factors associated with the chronicity of the disease questionnaire for collecting dietary habits through study completion, an average of 3 years
Primary Identify the environmental factors associated with the chronicity of the disease biological nutritional assessment research for a dysmetabolic syndrome through study completion, an average of 3 years
Primary Identify the environmental factors associated with the chronicity of the disease research for a dysmetabolic syndrome through study completion, an average of 3 years
Primary Identify the environmental factors associated with the chronicity of the disease lifestyle questionnaire assessing the impact on quality of life through study completion, an average of 3 years
Primary Involvement of innate immunity in the development of this chronic inflammation with skin biopsies for bacteriological samples skin biopsies of a closed nodule and axillary and inguinal bacteriological samples through study completion, an average of 3 years
Primary Determine the impact of vitamin D deficiency on inflammatory bowel disease skin biopsies of a closed nodule and axillary and inguinal bacteriological samples through study completion, an average of 3 years
Primary Determine the impact of IGF1 deficiency on inflammatory bowel disease skin biopsies of a closed nodule and axillary and inguinal bacteriological samples through study completion, an average of 3 years