Epidermolysis BullosaODEBNCT04853667
Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa
An observational study of Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- Interview
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2021to 20 May 2021
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children and adolescents with hereditary epidermolysis bullosa, follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital and their parents.
Who may be able to join
- Francophone children and adolescents with hereditary epidermolysis bullosa and of an age to express themselves verbally
- French-speaking holders of parental authority
- Regular follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital
- Pain at the time of treatment, the evaluation of which is greater than 4/10 (visual analogue scale VAS) without taking weak or strong opioid analgesics, yet prescribed as premedication
- Holders of parental authority and patients informed and not opposing their participation in the study
Who cannot join
- Children and adolescents without pain at the time of treatment or for whom paracetamol is sufficient to obtain good pain control
- Children and adolescents already taking analgesic treatments even if their pain is not well balanced at the time of care
Trial locations and contacts
1 site in 1 country.
About this study
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.
The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.
Read more
For an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.
The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.
Read the detailed description
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.
The Pain Medicine and Palliative Medicine Functional Unit (UFMDP) of Necker Hospital is involved on a daily basis in supporting the complex and multidisciplinary management of patients with the most serious forms of hereditary epidermolysis bullosa and their family.
The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.
The medical and paramedical professionals, from the UFMDP and from the reference center for Genetic Diseases with Cutaneous Expression (MAGEC) (Dermatology Department) of the Necker Hospital, surrounding these children, note that for an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.
Care is painful, increasing the vicious circle of anxiety, conflict with caregivers, family and ultimately pain.
The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.
- Conditions
- Epidermolysis Bullosa
- Being tested
- Interview
- Keywords
- Hereditary epidermolysis bullosa (HEB), Pain control, Analgesic treatments
- Medical subject headings
- Epidermolysis Bullosa, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Semi-structured interview, lasting a maximum of one hour
| Study group | Role | What they receive |
|---|---|---|
| Patients with hereditary epidermolysis bullosa | Minor patients with hereditary epidermolysis bullosa Receives: Other: Interview | |
| Parents | Parents of patients with hereditary epidermolysis bullosa Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to taking weak or strong opioid analgesics prescribed
Qualitative analysis of the semi-structured interview
Measured: Day 0
Secondary outcomes (1)
Barriers to giving weak or strong opioid analgesics prescribed
Qualitative analysis of the semi-structured interview
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 posted21 Apr 2021
- Study start29 Apr 2021
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sarah Chaumon, Principal investigator, Assistance Publique - Hôpitaux de ParisCéline Greco, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853667
- Sponsor's protocol ID
- APHP210420
- Other IDs
- 2021-A00418-33
- Acronym
- ODEB
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Understanding noncompliance with opioid-based analgesic premedications in the care of children with hereditary epidermolysis bullosa Authors : Sarah Chaumon, Christine Bodemer, Céline Greco Douleurs : Évaluation - Diagnostic - Traitement Volume 23, Issue 1, February 2022, Pages 14-24
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT04853667
- Acronym / sponsor ID
- ODEB / APHP210420
- Conditions
- Epidermolysis Bullosa
- Keywords
- Hereditary epidermolysis bullosa (HEB), Pain control, Analgesic treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 21 Apr 2021 (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.
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.
The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.
For an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.
The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.
Detailed description
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.
The Pain Medicine and Palliative Medicine Functional Unit (UFMDP) of Necker Hospital is involved on a daily basis in supporting the complex and multidisciplinary management of patients with the most serious forms of hereditary epidermolysis bullosa and their family.
The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.
The medical and paramedical professionals, from the UFMDP and from the reference center for Genetic Diseases with Cutaneous Expression (MAGEC) (Dermatology Department) of the Necker Hospital, surrounding these children, note that for an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.
Care is painful, increasing the vicious circle of anxiety, conflict with caregivers, family and ultimately pain.
The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hereditary epidermolysis bullosa | – | Other: InterviewMinor patients with hereditary epidermolysis bullosa |
| Parents | – | Other: InterviewParents of patients with hereditary epidermolysis bullosa |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adolescents with hereditary epidermolysis bullosa, follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital and their parents.
Key inclusion criteria (5 listed)
- Francophone children and adolescents with hereditary epidermolysis bullosa and of an age to express themselves verbally
- French-speaking holders of parental authority
- Regular follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital
- Pain at the time of treatment, the evaluation of which is greater than 4/10 (visual analogue scale VAS) without taking weak or strong opioid analgesics, yet prescribed as premedication
- Holders of parental authority and patients informed and not opposing their participation in the study
Key exclusion criteria (2 listed)
- Children and adolescents without pain at the time of treatment or for whom paracetamol is sufficient to obtain good pain control
- Children and adolescents already taking analgesic treatments even if their pain is not well balanced at the time of care
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 |
|---|---|---|
| InterviewSemi-structured interview, lasting a maximum of one hour | Other | Parents, Patients with hereditary epidermolysis bullosa |
Primary outcome
Barriers to taking weak or strong opioid analgesics prescribed
Time frame: Day 0
Qualitative analysis of the semi-structured interview
1 secondary outcome
Barriers to giving weak or strong opioid analgesics prescribed
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Results publicationUnderstanding noncompliance with opioid-based analgesic premedications in the care of children with hereditary epidermolysis bullosa Authors : Sarah Chaumon, Christine Bodemer, Céline Greco Douleurs : Évaluation - Diagnostic - Traitement Volume 23, Issue 1, February 2022, Pages 14-24
- Individual participant dataSharing planned: No
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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.
Sarah Chaumon principal investigator
Assistance Publique - Hôpitaux de Paris
Céline Greco, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermolysis Bullosa, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 9 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to taking weak or strong opioid analgesics prescribed (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853667, which also lists 1 linked publication.
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 9 Mar 2026.