Epidermolysis Bullosa DystrophicaNCT05390073
Growth Hormone in EB
An observational study of Epidermolysis Bullosa Dystrophica, run by Cairo University.
Trial summary
Growth is extremely affected in epidermolysis bullosa patients Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Epidermolysis Bullosa Dystrophica
- What is being tested?
- growth hormone level and insulin like growth factor 1
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2022to 15 Jun 2022
- 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 1 month to 12 years
- All sexes
- Child
Study population: Children with EB dystrophica
Who may be able to join
- Children with EB dystrophica
Who cannot join
- Adults with the same disease
About this study
Official title: Assessment of Growth Hormone and Insulin-like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophia
Growth is extremely affected in epidermolysis bullosa patients
Read the detailed description
Studying the role of growth hormone and ILGF-1 in EB may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood
- Conditions
- Epidermolysis Bullosa Dystrophica
- Being tested
- growth hormone level and insulin like growth factor 1
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormone level and insulin like growth factor 1Diagnostic test
laboratory test
What is being measured
The primary outcome is the main question the study is designed to answer.
level of growth hormone and insulin like growth factor 1
laboratory test
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start25 May 2022 (estimated)
- Primary completion10 Jun 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
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 Bullosa DystrophicaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390073
- Sponsor's protocol ID
- Growth in EB
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Darouti M, Zaki IS, Mousa N, El Sayed H. Assessment of Growth Hormone and Insulin-Like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophica. Pediatr Dermatol. 2025 Nov 24. doi: 10.1111/pde.70113. Online ahead of print.
PubMed 41287410
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth Hormone and Insulin-like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophia
- ClinicalTrials.gov ID
- NCT05390073
- Acronym / sponsor ID
- Growth in EB
- Conditions
- Epidermolysis Bullosa Dystrophica
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 25 May 2022 (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.
Growth is extremely affected in epidermolysis bullosa patients
Detailed description
Studying the role of growth hormone and ILGF-1 in EB may pave the to new therapeutic modality that could improve the growth in those children and avoid the irreversible sequelae that affected subjects experience after adulthood
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with EB dystrophica
Key inclusion criteria (1 listed)
- Children with EB dystrophica
Key exclusion criteria (1 listed)
- Adults with the same disease
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 |
|---|---|---|
| growth hormone level and insulin like growth factor 1laboratory test | Diagnostic test | – |
Primary outcome
level of growth hormone and insulin like growth factor 1
Time frame: 2 weeks
laboratory test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 41287410El Darouti M, Zaki IS, Mousa N, El Sayed H. Assessment of Growth Hormone and Insulin-Like Growth Factor 1 in Children With Epidermolysis Bullosa Dystrophica. Pediatr Dermatol. 2025 Nov 24. doi: 10.1111/pde.70113. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermolysis Bullosa Dystrophica, run by Cairo University.
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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
level of growth hormone and insulin like growth factor 1 (time frame: 2 weeks). 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 NCT05390073, 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 25 May 2022.