Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
NCT07920848, Not applicable, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort | ClinicalTrials.gov |
| NCT number | NCT07920848 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Hidradenitis Suppurativa (HS) | ClinicalTrials.gov |
| Interventions | Biological samples and questionnaires, Analysis of residual skin tissue | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa | At inclusion | * Differentially expressed genes and proteins * Enriched biological pathways involved in keratinisation, pilosebaceous unit biology, and innate and adaptive immunity * Skin and gut microbiota profiles (alpha/beta diversity, relative abundance of taxa of interest) | ClinicalTrials.gov |
| Secondary | Progression-free survival to Hurley stage II-III | Up to 96 months | Time from HS diagnosis to the date of progression to Hurley stage II-III | ClinicalTrials.gov |
| Secondary | Incidence rate of progression to Hurley stage II-III | Up to 96 months | expressed per 100 person-years of follow-up | ClinicalTrials.gov |
| Secondary | Number of newly involved anatomical regions during follow-up | Up to 96 months | Analysis of topographic extension | ClinicalTrials.gov |
| Secondary | Proportion of patients in need for major surgery (wide excision, extensive deroofing) and survival free of major surgery | Up to 96 months | time from HS diagnosis to the first surgical procedure | ClinicalTrials.gov |
| Secondary | Change in IHS4 during follow-up | Up to 96 months | absolute and relative change from inclusion at each annual visit | ClinicalTrials.gov |
| Secondary | Change in HS-PGA during follow-up | Up to 96 months | absolute and relative change from inclusion at each annual visit | ClinicalTrials.gov |
| Secondary | Rate of inflammatory flares per year of follow-up | Up to 96 months | ClinicalTrials.gov | |
| Secondary | Patient-reported score - Dermatology Life Quality Index | Up to 96 months | The Dermatology Life Quality Index (DLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on quality of life (0-1: no effect; 2-5: small effect; 6-10: moderate effect; 11-20: very large effect; 21-30: extremely large effect). The Children's Dermatology Life Quality Index (CDLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on the child's quality of life. | ClinicalTrials.gov |
| Secondary | Patient-reported score - HiSQOL | Up to 96 months | The Hidradenitis Suppurativa Quality of Life (HiSQOL) total score ranges from 0 to 68, with higher scores indicating a greater impact of hidradenitis suppurativa on quality of life. Les seuils publiés récemment sont : 0-4 none, 5-14 mild, 15-21 moderate, 22-23 severe, ≥24 very severe. | ClinicalTrials.gov |
| Secondary | Patient-reported score - VAS | Up to 96 months | Pain intensity is assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. | ClinicalTrials.gov |
| Secondary | Patient-reported score - HADS/ADRS | Up to 96 months | The Hospital Anxiety and Depression Scale (HADS) comprises two subscales, HADS-A for anxiety and HADS-D for depression, each ranging from 0 to 21. For each subscale, higher scores indicate greater symptom burden; scores of 0-7 indicate no significant symptoms, 8-10 borderline/doubtful symptoms, and 11-21 probable/significant symptoms. The Adolescent Depression Rating Scale (ADRS) self-report score ranges from 0 to 10, with higher scores indicating a higher risk of depressive symptoms. | ClinicalTrials.gov |
| Secondary | Patient-reported score - AUDIT-C | Up to 96 months | The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score ranges from 0 to 12, with higher scores indicating greater levels of potentially hazardous alcohol consumption. | ClinicalTrials.gov |
| Secondary | Patient-reported score - IPAQ - Short Form | Up to 96 months | Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ) and expressed in MET-minutes/week; higher values indicate greater physical activity. Physical activity may also be classified as low, moderate or high. | ClinicalTrials.gov |
| Secondary | Patient-reported score - EPICES | Up to 96 months | Socioeconomic deprivation is assessed using the EPICES score, with higher scores indicating greater socioeconomic deprivation; a score ≥30.17 is commonly used to identify socioeconomic deprivation. | ClinicalTrials.gov |
| Secondary | Patient-reported score - Short FFQ | Up to 96 months | Food Frequency Questionnaires | ClinicalTrials.gov |
| Secondary | Incidence rate of inflammatory and metabolic comorbidities during follow-up | Up to 96 months | ClinicalTrials.gov | |
| Secondary | Molecular and microbiological signatures differentially expressed over time within the same HS patient | Up to 96 months | ClinicalTrials.gov | |
| Secondary | Keratinocyte marker gene expression in skin biopsy and tape stripping | At inclusion | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)