Hidradenitis SuppurativaNCT06324552
Defects of Keratinocytes Function in Dermatologic Patients
An observational study of Hidradenitis Suppurativa, run by IRCCS Burlo Garofolo at 15 sites in 6 countries.
Trial summary
NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 50 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 12 Oct 2020to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults with clinical diagnosis of HS
Who may be able to join
- diagnosis of HS
Who cannot join
- no informed consent
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Italy8 sites, 7 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinic
Milan
Angelo Valerio Marzano, MD, angelo.marzano@unimi.it
- Recruiting
Azienda ospedaliero-universitaria pisana
Pisa
Valentina Pini, valentina.dini@unipi.it
- Recruiting
Istituto Dermopatico dell'Immacolata, IRCCS
Roma
Damiano Abeni, d.abeni@idi.it
- Active, not recruiting
Passion people
Roma
- Recruiting
Policlinico Universitario Fondazione A. Gemelli IRCCS
Roma
Andrea Chiricozzi, andrea.chiricozzi2@policlinicogemelli.it
- Recruiting
Ospedale Maggiore di Trieste
Trieste, 34125
Iris Zalaudek, MD, iris.zalaudek@asugi.sanita.fvg.it
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Paola Maura Tricarico, BSc, +39 0403785111, paolamaura.tricarico@burlo.trieste.it
- Recruiting
Ospedale San Bortolo
Vicenza
Andrea Sechi, andrea.sechi@hotmail.com
France2 sites
- Active, not recruiting
Université Paris Est-Créteil / INSERM U955- Mondor Institute For Biomedical Research (IMRB)
Créteil
- Active, not recruiting
Centre National de la Recherche Scientifique
Strasbourg
Germany2 sites, 1 recruiting
- Not yet recruiting
Dessau Medical Cente
Brandenburg
Christos C. Zouboulis, christos.zouboulis@gmx.de
- Completed
Uniklinik Köln
Cologne
Belgium1 site, 1 recruiting
- Recruiting
Université Libre de Bruxelles
Brussels
Veronique del Marmol, v.marmol@drvdm.be
About this study
Official title: Defects of Keratinocytes Function in Dermatologic Patients Carrying Genetic Variants Involved in NOTCH Signaling
NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, NOTCH signaling
- Medical subject headings
- Hidradenitis Suppurativa
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT)
Measured: Through study completion, an average of 36 months
Secondary outcomes (1)
Evaluation of the impact of photobiomodulation (PBM) therapy in hair follicles epithelial cells derived from patients and in HaCaT KO cells,
Measured: Through study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start12 Oct 2020
- Primary completion3 Jun 2023
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324552
- Sponsor's protocol ID
- RC 16/18
- Status last verified
- Jun 2024
- First submitted
- 15 Mar 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defects of Keratinocytes Function in Dermatologic Patients Carrying Genetic Variants Involved in NOTCH Signaling
- ClinicalTrials.gov ID
- NCT06324552
- Acronym / sponsor ID
- RC 16/18
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, NOTCH signaling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NOTCH signaling in the skin exerts a pivotal role in the regulation of normal keratinocytes turnover by mediating the balance between proliferation, differentiation, apoptosis and autophagic flux progression. Two skin diseases are characterized by the presence of gene variants that cause an impairment in NOTCH signaling: hidradenitis suppurativa(HS) and Dowling-Degos disease(DDD). To date, both HS and DDD are orphan diseases still lacking of specific treatments. This project aims at improving the current knowledge on the pathogenesis of HS and DDD, by deepening the understandings on the role played by keratinocytes in these pathologies and also by determining why mutations found in the same pathway cause different diseases. This study aimed to obtain in vitro models, derived directly from patients (from hair follicles) and from keratinocytes (HaCaT) cell cultures, for the study of these skin pathologies and also for the testing of novel innovative therapies such as photobiomodulation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults with clinical diagnosis of HS
Key inclusion criteria (1 listed)
- diagnosis of HS
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT)
Time frame: Through study completion, an average of 36 months
1 secondary outcome
Evaluation of the impact of photobiomodulation (PBM) therapy in hair follicles epithelial cells derived from patients and in HaCaT KO cells,
Time frame: Through study completion, an average of 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by IRCCS Burlo Garofolo at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, France, Germany, Austria, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Maura Tricarico, BSc (+39 0403785111, paolamaura.tricarico@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of candidate variants in hair follicles epithelial cell biology by generating Knock-Out (KO) keratinocyte cell lines (HaCaT) (time frame: Through study completion, an average of 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.