Ehlers-Danlos SyndromeSEDSKINNCT06336473
Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome
A study testing skin biopsy in people with Ehlers-Danlos Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- skin biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 or over, having read and signed the consent form for participation in the study
- Patient with classic or hypermobile Ehlers-Danlos syndrome
- Regularly followed-up at the non-vascular Ehlers-Danlos Syndrome Reference Center at Garches Hospital.
Who cannot join
- Patient under court protection, guardianship or curatorship
- Pregnant or breast-feeding patient
- Patient not affiliated to the French social security system
- Impossibility of giving the subject informed information and/or written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
- Contraindication to anaesthesia or allergy to local anaesthetic product
Trial locations and contacts
1 site in 1 country.
About this study
The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS).
Read the detailed description
This is a single-center study based on skin biopsies. The skin biopsies will be taken at the non-vascular Ehlers-Danlos syndromes reference center at the Raymond Poincaré Hospital (Garches), by Dr. Karelle Benistan. This center regularly performs this type of biopsy as part of its routine care, and has set up a fibroblast bank for Genethon (Authorization for biological collection at Genethon: SED BACG n° DC-2021-4628).
Samples will be transported to the Centre de Recherche Saint-Antoine (UMR-S 938) where they will be processed, cut and placed on histological slides.
Atomic force microscopy analyses will be carried out at the Laboratoire de Réactivité de Surface (CNRS/Sorbonne University).
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- skin biopsy
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
Samples will be taken under local anaesthetic (after injection of 1 cc of Xylocaine without adrenaline) using a 4 mm diameter dermal biopsy punch. The biopsy will be performed on the buttocks. Fragments are stored in 15-mL polypropylene tubes in PBS at 4°C.
| Study group | Role | What they receive |
|---|---|---|
| Skin biopsy | Experimental | Not described Receives: Procedure: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young's modulus quantification
Atomic force microscopy (AFM), in contact mode, enables force curves to be obtained. The tip no longer scans the surface of the sample, but probes the surface at several indentation points.
A microlever deflection curve is generated for each indentation point.
Calculation of Young's modulus is based on Bilodeau's model, in which the tip is assimilated to a pyramid in contact with a flat surface.
F is the measured force, E the modulus of elasticity, α the face angle of the pyramid, δ the indentation depth and ν the Poisson's ratio of the sample, set at 0.5 (corresponding to an incompressible material).
Young's modulus will be quantified by AFM
Measured: Day 0
Secondary outcomes (2)
Collagen fibril diameter measurement
Three 2 μm x 2 μm images with at least 100 scan lines will be acquired on each sample and used to describe the intrinsic characteristics of collagen fibrils.
Measured: Day 0
Collagen fibril D-period length measurement
Three 2 μm x 2 μm images with at least 100 scan lines will be acquired on each sample and used to describe the intrinsic characteristics of collagen fibrils.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 Sep 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center study performed on biopsied skin samples
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336473
- Sponsor's protocol ID
- 2023-A02097-38
- Acronym
- SEDSKIN
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT06336473
- Acronym / sponsor ID
- SEDSKIN / 2023-A02097-38
- Conditions
- Ehlers-Danlos Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 3 Sep 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 28 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.
The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS).
Detailed description
This is a single-center study based on skin biopsies. The skin biopsies will be taken at the non-vascular Ehlers-Danlos syndromes reference center at the Raymond Poincaré Hospital (Garches), by Dr. Karelle Benistan. This center regularly performs this type of biopsy as part of its routine care, and has set up a fibroblast bank for Genethon (Authorization for biological collection at Genethon: SED BACG n° DC-2021-4628).
Samples will be transported to the Centre de Recherche Saint-Antoine (UMR-S 938) where they will be processed, cut and placed on histological slides.
Atomic force microscopy analyses will be carried out at the Laboratoire de Réactivité de Surface (CNRS/Sorbonne University).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center study performed on biopsied skin samples
| Arm | Type | Receives |
|---|---|---|
| Skin biopsy | Experimental | Procedure: skin biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 or over, having read and signed the consent form for participation in the study
- Patient with classic or hypermobile Ehlers-Danlos syndrome
- Regularly followed-up at the non-vascular Ehlers-Danlos Syndrome Reference Center at Garches Hospital.
Key exclusion criteria (5 listed)
- Patient under court protection, guardianship or curatorship
- Pregnant or breast-feeding patient
- Patient not affiliated to the French social security system
- Impossibility of giving the subject informed information and/or written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patient
- Contraindication to anaesthesia or allergy to local anaesthetic product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsySamples will be taken under local anaesthetic (after injection of 1 cc of Xylocaine without adrenaline) using a 4 mm diameter dermal biopsy punch. The biopsy will be performed on the buttocks. Fragments are stored in 15-mL polypropylene tubes in PBS at 4°C. | Procedure or surgery | Skin biopsy |
Primary outcome
Young's modulus quantification
Time frame: Day 0
Atomic force microscopy (AFM), in contact mode, enables force curves to be obtained. The tip no longer scans the surface of the sample, but probes the surface at several indentation points. A microlever deflection curve is generated for each indentation point. Calculation of Young's modulus is based on Bilodeau's model, in which the tip is assimilated to a pyramid in contact with a flat surface. F is the measured force, E the modulus of elasticity, α the face angle of the pyramid, δ the indentation depth and ν the Poisson's ratio of the sample, set at 0.5 (corresponding to an incompressible material). Young's modulus will be quantified by AFM
2 secondary outcomes
Collagen fibril diameter measurement
Time frame: Day 0
Collagen fibril D-period length measurement
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Ehlers-Danlos Syndrome, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 3 inclusion and 5 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 24 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 1 site in France. 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 Geoffroy NOURISSAT, MD (07 69 99 67 30 ext. 33, gnourissat@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young's modulus quantification (time frame: Day 0). 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 24 Jun 2024.