Epidermolysis BullosaPhase 1NCT00014729
Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
A Phase 1 study testing isotretinoin in people with Epidermolysis Bullosa, run by University of North Carolina.
Trial summary
OBJECTIVES: I. Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- isotretinoin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Sep 2002
- Phase
- Phase 1
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) RDEB Hallopeau-Siemens OR RDEB non-Hallopeau-Siemens
- Concurrent enrollment in the National Epidermolysis Bullosa Registry
- No regional or distant metastasis in patients with previous or concurrent squamous cell carcinoma
--Patient Characteristics--
- Hepatic: No clinically significant hypertriglyceridemia No clinically significant hepatic dysfunction
- Renal: No clinically significant renal dysfunction
- Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
About this study
OBJECTIVES:
- Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.
Read the detailed description
PROTOCOL OUTLINE:
Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Epidermolysis Bullosa
- Being tested
- isotretinoin
- Keywords
- dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Epidermolysis Bullosa, Skin Diseases, Genetic Diseases, Inborn, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotretinoinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2001 (estimated)
- Study startOct 2000
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis BullosaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Investigators
- Jo-David Fine, Study chair, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014729
- Sponsor's protocol ID
- 199/15738
- Other IDs
- UNCCH-FDR001796
- Status last verified
- May 2001
- First submitted
- 10 Apr 2001
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT00014729
- Acronym / sponsor ID
- 199/15738
- Conditions
- Epidermolysis Bullosa
- Keywords
- dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Study start
- Oct 2000
- Study completion
- Sep 2002
- First posted
- 11 Apr 2001 (estimated)
- 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.
OBJECTIVES:
- Determine the safety of isotretinoin in patients with recessive dystrophic epidermolysis bullosa.
Detailed description
PROTOCOL OUTLINE:
Patients receive oral isotretinoin daily for 8 months in the absence of disease progression or unacceptable toxicity.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| isotretinoin | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
Related trials for Epidermolysis Bullosa
Not yet recruitingPhase 2
Filsuvez in Moderate-to-Severe Epidermolysis Bullosa Simplex
Epidermolysis Bullosa Simplex
RecruitingPhase 2
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa
RecruitingPhase 3
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Epidermolysis Bullosa (EB)
RecruitingPhase 2
A Study to Evaluate ENERGI-F703EB Cream in Epidermolysis Bullosa
Epidermolysis Bullosa (EB), Junctional Epidermolysis Bullosa
RecruitingObservational study
A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
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.
Jo-David Fine study chair
University of North Carolina
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isotretinoin in people with Epidermolysis Bullosa, run by University of North Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 25 Mar 2015.