Epidermolysis BullosaPhase 2NCT00825565

Study of Alwextin® Cream in Treating Epidermolysis Bullosa

A Phase 2 study testing Alwextin cream in people with Epidermolysis Bullosa, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine how safe and effective allantoin 3% cream (Alwextin) is in improving the healing of recurrent skin lesions and reducing overall blistering in people with epidermolysis bullosa (EB). Allantoin 3% cream is applied topically to the entire body once daily. Read more about this study

Who is it for?: Ages 6 months and older
Conditions the study is for: Epidermolysis Bullosa
What is being tested?: Alwextin cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Nov 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

history of epidermolysis bullosa

Who cannot join

use of any skin product containing allantoin for 30 days prior to enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Robert and Ann Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa

Read the detailed description

Potential subjects came to the for a screening visit. Eligible subjects had baseline assessments performed and were provided study medication, allantoin 3% cream. Subjects were instructed to apply the study medication to the entire body once daily and to keep daily record of study medication use. Subjects returned every 4 weeks for a total of 12 weeks for repeat assessments.

Conditions: Epidermolysis Bullosa
Being tested: Alwextin cream
Keywords: Epidermolysis bullosa
Medical subject headings: Epidermolysis Bullosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alwextin creamDrug
Also called Alwextin, Alwyn, allantoin
Alwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.

Study groups in NCT00825565
Study group	Role	What they receive
Alwextin cream	Experimental	8 subjects enrolled in this single study arm. All 8 subjects completed the study. Receives: Drug: Alwextin cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease "spread" with weighting factors.
Measured: baseline and then every 4 weeks for a total of 12 weeks
Target Wound Size Reduction or Closure
EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream.
Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital.
Measured: baseline and then every 4 weeks for a total of 12 weeks
Physician Global Assessment of Severity (PGAS)
The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a "global impression."
This scale produced a score with the following correlations:
0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)
Measured: baseline and then every 4 weeks for a total of 12 weeks
Physician Assessment of Individual Signs
In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated.
This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe
Measured: baseline and at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Nov 2010

First posted21 Jan 2009 (estimated)
Study startFeb 2009
Primary completionNov 2010
Study completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
More trials run by Northwestern 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00825565
Sponsor's protocol ID: Alwextin 3.0%-04
Status last verified: Jan 2018
First submitted: 19 Jan 2009
Last updated: 28 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Epidermolysis Bullosa trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Pilot Study to Investigate the Safety and Tolerability of Alwextin 3.0% Cream in the Treatment of Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT00825565
Acronym / sponsor ID: Alwextin 3.0%-04
Conditions: Epidermolysis Bullosa
Keywords: Epidermolysis bullosa
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
Study start: Feb 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 21 Jan 2009 (estimated)
Results: Posted 1 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Alwextin cream	Experimental	Drug: Alwextin cream8 subjects enrolled in this single study arm. All 8 subjects completed the study.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

history of epidermolysis bullosa

Key exclusion criteria (1 listed)

use of any skin product containing allantoin for 30 days prior to enrollment

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
Alwextin creamAlso: Alwextin, Alwyn, allantoinAlwextin cream contains active ingredient, allantoin 3%. Use 1 application daily for 3 month duration.	Drug	Alwextin cream

Primary outcome

Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage
Time frame: baseline and then every 4 weeks for a total of 12 weeks
A common measure of the degree of involvement in skin disease is the Body Surface Area Index (BSAI). This measure is also commonly used in psoriasis studies. It is a global measure of disease "spread" with weighting factors.
Target Wound Size Reduction or Closure
Time frame: baseline and then every 4 weeks for a total of 12 weeks
EB patients may have chronic wounds which are resistant to healing. Wound size may be very large and the probability of total wound closure with currently available treatments is unlikely. Reduction in the size of wounds may be clinically important to the rate of infection and pain. If a patient has a reduction in the size of wounds which are refractory to healing, this may be seen as a positive outcome. Wound size reduction is one of the primary assessments used to determine the efficacy of the study cream. Wounds which had been present for at least several weeks prior to study entry were measured by using VISITRAK Digital, a Smith and Nephew wound tracing and measurement system that will calculate the length and width of the lesion (class 1 medical device; FDA listing designation E142354FDA). Only one target lesion per patient was used for the study assessment. At each subsequent study until the final visit, the target lesion was evaluated using VISITRAK Digital.
Physician Global Assessment of Severity (PGAS)
Time frame: baseline and then every 4 weeks for a total of 12 weeks
The FDA has suggested that a global measure of severity might be the best way to assess EB from visit to visit. Assessment score may be influenced by other clinical observations in addition to the percentage of body affected by blistering and erosions. The assessment was intended to be a "global impression." This scale produced a score with the following correlations: 0 = clear (no blistering/erosions) 1-2 = almost clear (infrequent blistering and erosions) 3-4 = mild disease (up to 15% of body affected) 5-6 = moderate disease (between 16-25% of body affected) 7-8 = severe disease (between 26-50% of body affected) 9-10 = very severe disease (greater than 50% of body affected)
Physician Assessment of Individual Signs
Time frame: baseline and at 12 weeks
In addition to skin blistering and erosions, people with EB experience other symptoms, such as erythema on unblistered skin, wound oozing, weeping, and crusting. These symptoms may vary with area of the body evaluated. This scale evaluates the following signs: Blistering and erosions, oozing/weeping/crusting, pruritis, erythema on unblistered surrounding skin, pain, milia Each of these signs will be scored in 4 body areas: head/neck, upper limbs, trunk, lower limbs The following scale is used:0 = clear 1 = almost clear 2 = mild 3 = moderate 4 = severe

Results and safety

Results posted to the registry on 1 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allantoin 3% Cream	8	8

Primary outcome: Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage

Time frame: baseline and then every 4 weeks for a total of 12 weeks. Mean (Standard Deviation). Unit: percentage of BSA involvement

Measure	Allantoin 3% Cream n = 8
Baseline assessment	57.25 (19.1)
Week 4 assessment	39.40 (24.1)
Week 8 assessment	27.25 (17.9)
Week 12 assessment	25.45 (21.1)

Population analysed: Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis.

Primary outcome: Target Wound Size Reduction or Closure

Time frame: baseline and then every 4 weeks for a total of 12 weeks. Number. Unit: number of unhealed target wounds

Measure	Allantoin 3% Cream n = 8
Baseline assessment	8
Week 12 assessment	1

Population analysed: Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis.

Primary outcome: Physician Global Assessment of Severity (PGAS)

Time frame: baseline and then every 4 weeks for a total of 12 weeks. Count of participants. Unit: Participants

Measure	Alwextin Cream n = 8
Baseline: PGAS score of 1	0
Baseline: PGAS score of 2	0
Baseline: PGAS score of 3	0
Baseline: PGAS score of 4	0
Baseline: PGAS score of 5	0
Baseline: PGAS score of 6	0
Baseline: PGAS score of 7	1
Baseline: PGAS score of 8	2

Population analysed: One subject discontinued after week 3. One subject discontinued at Month 2. Only data presented for subjects who used cream on entire body for the entire month was used in the analysis.

Primary outcome: Physician Assessment of Individual Signs

Time frame: baseline and at 12 weeks. Count of participants. Unit: Participants

Measure	Head/Neck n = 8	Upper Limbs n = 8	Trunk n = 8	Lower Limbs n = 8
Pain-Baseline: Clear	1	0	0	0
Pain-Baseline: Almost Clear	4	4	3	1
Pain-Baseline: Mild	2	1	0	1
Pain-Baseline: Moderate	0	1	3	2
Pain-Baseline: Severe	1	2	2	4
Pain-Month 3: Clear	2	2	2	2
Pain-Month 3: Almost Clear	0	0	0	0
Pain-Month 3: Mild	2	1	1	1

Population analysed: Subjects who used cream on entire body for the entire month was used in the analysis.

Adverse events

Time frame: For 12 week duration of study. Adverse events (AE) and serious adverse events (SAE_that were unresolved by study completion date were followed for an additional 1 month post-study completion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allantoin 3% Cream	0 of 8 (0%)	4 of 8 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Amy S Paller, MD principal investigator

Northwestern University

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 Alwextin cream in people with Epidermolysis Bullosa, run by Northwestern University at 1 site in United States.

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: finished, as of the sponsor's last update on 28 Feb 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 United States. 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?

Yes. Results are posted in the registry (first posted 1 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage (time frame: baseline and then every 4 weeks for a total of 12 weeks). The study lists 4 primary outcomes in all. 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 NCT00825565.

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 28 Feb 2018.