Trial · NCT00825565
Study of Alwextin® Cream in Treating Epidermolysis Bullosa
NCT00825565, Phase 2, Completed, Northwestern University; results first posted 2013-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Alwextin® Cream in Treating Epidermolysis Bullosa. Trials, record NCT00825565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00825565
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Alwextin® Cream in Treating Epidermolysis Bullosa
- NCT number
- NCT00825565
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Epidermolysis Bullosa
- Interventions
- Alwextin cream
- First posted
- 2009-01-21
- Last updated
- 2018-02-28
- Results first posted
- 2013-01-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | 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. |
| Primary | Target Wound Size Reduction or Closure | 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. |
| Primary | Physician Global Assessment of Severity (PGAS) | 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) |
| Primary | Physician Assessment of Individual Signs | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | baseline and then every 4 weeks for a total of 12 weeks | Subjects who used allantoin 3% cream for an entire month prior to the BSA monthly assessment were included in the analysis. | percentage of BSA involvement | MEAN |
| PRIMARY | Target Wound Size Reduction or Closure | baseline and then every 4 weeks for a total of 12 weeks | Subjects who used allantoin 3% cream on the target wound daily up to full closure of that wound were included in the analysis. | number of unhealed target wounds | NUMBER |
| PRIMARY | Physician Global Assessment of Severity (PGAS) | baseline and then every 4 weeks for a total of 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Physician Assessment of Individual Signs | baseline and at 12 weeks | Subjects who used cream on entire body for the entire month was used in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group286
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | Allantoin 3% Cream | Baseline assessment | 57.25 | Standard Deviation 19.1 | percentage of BSA involvement |
| Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | Allantoin 3% Cream | Week 4 assessment | 39.40 | Standard Deviation 24.1 | percentage of BSA involvement |
| Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | Allantoin 3% Cream | Week 8 assessment | 27.25 | Standard Deviation 17.9 | percentage of BSA involvement |
| Blister/Erosion Reduction Based on Change in Body Surface Area (BSA) Coverage | Allantoin 3% Cream | Week 12 assessment | 25.45 | Standard Deviation 21.1 | percentage of BSA involvement |
| Target Wound Size Reduction or Closure | Allantoin 3% Cream | Baseline assessment | 8 | number of unhealed target wounds | |
| Target Wound Size Reduction or Closure | Allantoin 3% Cream | Week 12 assessment | 1 | number of unhealed target wounds | |
| Physician Global Assessment of Severity (PGAS) | Alwextin Cream | Baseline / PGAS score of 1 | 0 | Participants | |
| Physician Global Assessment of Severity (PGAS) | Alwextin Cream | Baseline / PGAS score of 2 | 0 | Participants | |
| Physician Global Assessment of Severity (PGAS) | Alwextin Cream | Baseline / PGAS score of 3 | 0 | Participants | |
| Physician Global Assessment of Severity (PGAS) | Alwextin Cream | Baseline / PGAS score of 4 | 0 | Participants |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Allantoin 3% Cream | 8 | |
| Overall Study | COMPLETED | Allantoin 3% Cream | 8 | |
| Overall Study | NOT COMPLETED | Allantoin 3% Cream | 0 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | red, itchy skin | Skin and subcutaneous tissue disorders | Allantoin 3% Cream | 1 | 8 | 1 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Allantoin 3% Cream | 1 | 8 | 1 |
| other | fever | General disorders | Allantoin 3% Cream | 2 | 8 | 2 |
| other | red spots on right foot | Skin and subcutaneous tissue disorders | Allantoin 3% Cream | 1 | 8 | 1 |
| other | red spots on left foot | Skin and subcutaneous tissue disorders | Allantoin 3% Cream | 1 | 8 | 1 |
| other | diarrhea | Gastrointestinal disorders | Allantoin 3% Cream | 1 | 8 | 1 |
| other | hematemesis | Gastrointestinal disorders | Allantoin 3% Cream | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allantoin 3% Cream | ||
| Total, other adverse events | Allantoin 3% Cream | 4 | 8 |
| Total, serious adverse events | Allantoin 3% Cream | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00825565
GET https://conductscience.org/api/trials/v1/NCT00825565/results?page=2