Trial · NCT02014376
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
NCT02014376, Phase 2, Completed, Scioderm, Inc.; results first posted 2020-01-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa. Trials, record NCT02014376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02014376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
- NCT number
- NCT02014376
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Scioderm, Inc.
- Conditions
- Epidermolysis Bullosa
- Interventions
- SD-101 dermal cream (3%), SD-101 Dermal Cream (6%), Vehicle (SD-101 0%)
- First posted
- 2013-12-18
- Last updated
- 2020-01-13
- Results first posted
- 2020-01-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Baseline to 1 Month | The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented. |
| Secondary | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Baseline to Month 2 and Month 3 | The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented. |
| Secondary | Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | Baseline, Month 3 | The BSAI is a global measure of disease "spread" with weighting factors. Lesional skin consisted of area(s) that could contain any of the following: blisters, bullae, erosions, ulcerations, scabbing and eschars, as well as areas that are weeping, sloughing, oozing, crusted and denuded. The percentage, ranging from 0% to 100%, of affected body surface area was recorded for each defined body region (head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSAI affected with blisters and wounds was calculated at baseline and Month 3 to assess the total affected area. Percentage change from baseline was calculated as follows: Percentage change from baseline = 100\*(Post-baseline value minus Baseline value) divided by Baseline value. Mean percentage change from baseline in BSAI is reported. Only participants with data available for analysis at the specified time point are presented. |
| Secondary | Participants Experiencing A Change From Baseline In Itching At Day 7 | Baseline, Day 7 | The Itch Man Pruritus Assessment Tool was used to measure the intensity of itching. Itching was assessed and reported at Baseline and Day 7. For participants 6 months to 5 years of age, itching was assessed using the caretaker's response, while in participants 6 years and older, itching was self-reported. |
| Secondary | Change From Baseline In Pain At Day 7 | Baseline, Day 7 | Pain was assessed at Baseline and Day 7. The presence and intensity of pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale for participants 6 months to 3 years of age. For participants aged 4 years and older, the Wong Faces Pain Scale was used. Scores were attributed for each of the 5 categories in the FLACC scale from 0 to 2, which resulted in a total score between 0 and 10. The Wong Faces Pain scale used 1 item to rate pain on a 0 to 10 scale. Higher score values indicated more pain. |
| Secondary | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2, Month 1, Month 2, and Month 3 | In the event of a healed wound, where complete closure was confirmed, the extent of scarring was assessed as "Present" or "Absent" at all post-baseline visits (Week 2 and Months 1, 2, and 3). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Baseline to 1 Month | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Baseline to Month 2 and Month 3 | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3 | Baseline, Month 3 | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug. | percentage of BSAI | MEAN |
| SECONDARY | Participants Experiencing A Change From Baseline In Itching At Day 7 | Baseline, Day 7 | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline In Pain At Day 7 | Baseline, Day 7 | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug. | score on a scale | MEAN |
| SECONDARY | Participants With Scarring At Week 2, Month 1, Month 2, And Month 3 | Week 2, Month 1, Month 2, and Month 3 | Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, had received at least 1 application of study drug, and whose target wounds healed while receiving study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | SD-101 Dermal Cream (6%) | Yes | 8 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | SD-101 Dermal Cream (3%) | Yes | 6 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Vehicle (0%) | Yes | 7 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | SD-101 Dermal Cream (6%) | No | 7 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | SD-101 Dermal Cream (3%) | No | 10 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment | Vehicle (0%) | No | 10 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | SD-101 Dermal Cream (6%) | Yes: Month 2 | 9 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | SD-101 Dermal Cream (3%) | Yes: Month 2 | 7 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | Vehicle (0%) | Yes: Month 2 | 7 | Participants | |
| Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment | SD-101 Dermal Cream (6%) | No: Month 2 | 6 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SD-101 Dermal Cream (6%) | 15 | |
| Overall Study | STARTED | SD-101 Dermal Cream (3%) | 16 | |
| Overall Study | STARTED | Vehicle (0%) | 17 | |
| Overall Study | Received at Least 1 Dose of Study Drug | SD-101 Dermal Cream (6%) | 15 | |
| Overall Study | Received at Least 1 Dose of Study Drug | SD-101 Dermal Cream (3%) | 16 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Vehicle (0%) | 17 | |
| Overall Study | COMPLETED | SD-101 Dermal Cream (6%) | 12 | |
| Overall Study | COMPLETED | SD-101 Dermal Cream (3%) | 15 | |
| Overall Study | COMPLETED | Vehicle (0%) | 17 | |
| Overall Study | NOT COMPLETED | SD-101 Dermal Cream (6%) | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events177
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 | Nasopharyngitis | Infections and infestations | SD-101 Dermal Cream (6%) | 1 | 15 | |
| other | Nasopharyngitis | Infections and infestations | SD-101 Dermal Cream (3%) | 4 | 16 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle (0%) | 2 | 17 | |
| other | Otitis media | Infections and infestations | SD-101 Dermal Cream (6%) | 1 | 15 | |
| other | Otitis media | Infections and infestations | SD-101 Dermal Cream (3%) | 0 | 16 | |
| other | Otitis media | Infections and infestations | Vehicle (0%) | 1 | 17 | |
| other | Pharyngitis streptococcal | Infections and infestations | SD-101 Dermal Cream (6%) | 1 | 15 | |
| other | Pharyngitis streptococcal | Infections and infestations | SD-101 Dermal Cream (3%) | 0 | 16 | |
| other | Pharyngitis streptococcal | Infections and infestations | Vehicle (0%) | 1 | 17 | |
| other | Rhinitis | Infections and infestations | SD-101 Dermal Cream (6%) | 2 | 15 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SD-101 Dermal Cream (6%) | 0 | 15 |
| Total, all-cause mortality | SD-101 Dermal Cream (3%) | 0 | 16 |
| Total, all-cause mortality | Vehicle (0%) | 0 | 17 |
| Total, other adverse events | SD-101 Dermal Cream (6%) | 9 | 15 |
| Total, other adverse events | SD-101 Dermal Cream (3%) | 13 | 16 |
| Total, other adverse events | Vehicle (0%) | 12 | 17 |
| Total, serious adverse events | SD-101 Dermal Cream (6%) | 0 | 15 |
| Total, serious adverse events | SD-101 Dermal Cream (3%) | 2 | 16 |
| Total, serious adverse events | Vehicle (0%) | 1 | 17 |
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/NCT02014376
GET https://conductscience.org/api/trials/v1/NCT02014376/results?page=2