Epidermolysis BullosaPhase 2NCT00380640
The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
A Phase 2 study testing Trimethoprim in people with Epidermolysis Bullosa, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa. Read more about this study
- Who is it for?
- Ages 1 day to 20 years
- Conditions the study is for
- Epidermolysis Bullosa
- What is being tested?
- Trimethoprim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2007
- Phase
- Phase 2
- 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 day to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients younger than 20 years of age
- Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis Bullosa (JEB)
- Signed consent/assent form
Who cannot join
- -Previous known allergy or intolerance to trimethoprim
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa.
Read the detailed description
Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by fragility of the skin and mucous membranes and the tendency of the skin to blister in response to minor friction or trauma. The care of patients with EB is a complex task that has to be carried out by a multi-professional team. In the absence of a cure, the goal of therapy is the prevention and healing of chronic wounds.
In patients with EB, chronic inflammation interferes with proper wound healing. One treatment option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten wound healing and decrease blister formation. This treatment may lead to decreased pain and improvement of the quality of life for these patients.
- Conditions
- Epidermolysis Bullosa
- Being tested
- Trimethoprim
- Keywords
- Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing
- Medical subject headings
- Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimethoprimDrug
This group will receive the active intervention (trimethoprim) first, followed by the placebo.
TrimethoprimDrug
This group will start the study with placebo, followed by the active intervention (trimethoprim).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Trimethoprim |
| 2 | Experimental | Not described Receives: Drug: Trimethoprim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds
Measured: At 2 months, 3 months and 5 months after baseline visit
Secondary outcomes (6)
Total number of blisters at each visit
Measured: At 2 months, 3 months and 5 months after baseline visit
Total number of opened areas at each visit
Measured: At 2 months, 3 months and 5 months after baseline visit
Qualitative wound score
Measured: At 2 months, 3 months and 5 months after baseline visit
Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit
Measured: At 2 months, 3 months and 5 months after baseline visit
Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule
Measured: At 2 months, 3 months and 5 months after baseline visit
Number of infections that require systemic antibiotics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionSep 2007
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.
- More trials run by The Hospital for Sick ChildrenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Pope, The Hospital for Sick Children
- Investigators
- Elena Pope, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380640
- Sponsor's protocol ID
- 1000009064
- Status last verified
- Apr 2018
- First submitted
- 25 Sep 2006
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa: A Randomized, Double Blinded, Placebo Controlled, Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT00380640
- Acronym / sponsor ID
- 1000009064
- Conditions
- Epidermolysis Bullosa
- Keywords
- Pediatrics, Epidermolysis Bullosa, Trimethoprim, Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Sep 2006 (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.
The purpose of this study is to assess the efficacy of trimethoprim in promoting wound healing and decreasing blister formation in patients with Epidermolysis Bullosa.
Detailed description
Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by fragility of the skin and mucous membranes and the tendency of the skin to blister in response to minor friction or trauma. The care of patients with EB is a complex task that has to be carried out by a multi-professional team. In the absence of a cure, the goal of therapy is the prevention and healing of chronic wounds.
In patients with EB, chronic inflammation interferes with proper wound healing. One treatment option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten wound healing and decrease blister formation. This treatment may lead to decreased pain and improvement of the quality of life for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Trimethoprim |
| 2 | Experimental | Drug: Trimethoprim |
Who may qualify
- Ages
- 1 day to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients younger than 20 years of age
- Diagnosis of Recessive Dystrophic Epidermis Bullosa (RDEB)or Junctional Epidermis Bullosa (JEB)
- Signed consent/assent form
Key exclusion criteria (1 listed)
- -Previous known allergy or intolerance to trimethoprim
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 |
|---|---|---|
| TrimethoprimThis group will receive the active intervention (trimethoprim) first, followed by the placebo. | Drug | 1 |
| TrimethoprimThis group will start the study with placebo, followed by the active intervention (trimethoprim). | Drug | 2 |
Primary outcome
Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds
Time frame: At 2 months, 3 months and 5 months after baseline visit
6 secondary outcomes
Total number of blisters at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Total number of opened areas at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Qualitative wound score
Time frame: At 2 months, 3 months and 5 months after baseline visit
Parent/patient/physician perception of improvement, assessed with a visual analog scale at each visit
Time frame: At 2 months, 3 months and 5 months after baseline visit
Quality of life, assessed by the Children's Dermatology Life Quality Index (CDLQI) and the Cardiff Wound Impact Schedule
Time frame: At 2 months, 3 months and 5 months after baseline visit
Number of infections that require systemic antibiotics
Time frame: 6 months
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 19 Apr 2018.
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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.
Elena Pope, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimethoprim in people with Epidermolysis Bullosa, run by The Hospital for Sick Children at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 19 Apr 2018. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Percentage change of area of the wound from visit to visit, estimated from the longest length and width of up to three target chronic wounds (time frame: At 2 months, 3 months and 5 months after baseline visit). 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 19 Apr 2018.