Trial · NCT02090283
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
NCT02090283, Phase 2, Terminated, Scioderm, Inc.; results first posted 2019-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa. Trials, record NCT02090283. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02090283
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
- NCT number
- NCT02090283
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Scioderm, Inc.
- Conditions
- Epidermolysis Bullosa
- Interventions
- SD-101 dermal cream (6%)
- First posted
- 2014-03-18
- Last updated
- 2019-11-04
- Results first posted
- 2019-11-04
- Limitations and caveats
- Results are presented for all participants who received SD-101 before the early termination of the study on 4 June 2018. The maximum study duration completed by at least 1 participant was 54 months.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline to 30 days after last application of study drug (up to a maximum of 54 months) | Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24 | Baseline, Month 24 | Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, 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 BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline (final visit from the SD-003 study) in BSAI was assessed every 3 months. Only participants with data available for analysis at the specified time point are presented. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline to 30 days after last application of study drug (up to a maximum of 54 months) | Safety: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24 | Baseline, Month 24 | Intent to Treat: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug. | percentage of BSAI | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to SD-101-6.0 | Any TEAE | 13 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-3.0 to SD-101-6.0 | Any TEAE | 14 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-6.0 to SD-101-6.0 | Any TEAE | 5 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to SD-101-6.0 | Any TEAE Related to Study Drug | 1 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-3.0 to SD-101-6.0 | Any TEAE Related to Study Drug | 1 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-6.0 to SD-101-6.0 | Any TEAE Related to Study Drug | 0 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to SD-101-6.0 | Any Fatal TEAE | 0 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-3.0 to SD-101-6.0 | Any Fatal TEAE | 0 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | SD-101-6.0 to SD-101-6.0 | Any Fatal TEAE | 0 | Participants | |
| Number Of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo to SD-101-6.0 | Serious TEAE | 4 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo to SD-101-6.0 | 17 | |
| Overall Study | STARTED | SD-101-3.0 to SD-101-6.0 | 15 | |
| Overall Study | STARTED | SD-101-6.0 to SD-101-6.0 | 10 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | Placebo to SD-101-6.0 | 17 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | SD-101-3.0 to SD-101-6.0 | 15 | |
| Overall Study | Received At Least 1 Dose Of Study Drug | SD-101-6.0 to SD-101-6.0 | 10 | |
| Overall Study | COMPLETED | Placebo to SD-101-6.0 | 0 | |
| Overall Study | COMPLETED | SD-101-3.0 to SD-101-6.0 | 0 | |
| Overall Study | COMPLETED | SD-101-6.0 to SD-101-6.0 | 0 | |
| Overall Study | NOT COMPLETED | Placebo to SD-101-6.0 | 17 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events315
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 | Anaemia | Blood and lymphatic system disorders | Placebo to SD-101-6.0 | 3 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | SD-101-3.0 to SD-101-6.0 | 0 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | SD-101-6.0 to SD-101-6.0 | 0 | 10 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | Placebo to SD-101-6.0 | 0 | 17 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | SD-101-3.0 to SD-101-6.0 | 1 | 15 | |
| other | Tympanic membrane perforation | Ear and labyrinth disorders | SD-101-6.0 to SD-101-6.0 | 0 | 10 | |
| other | Conjunctivitis | Eye disorders | Placebo to SD-101-6.0 | 0 | 17 | |
| other | Conjunctivitis | Eye disorders | SD-101-3.0 to SD-101-6.0 | 2 | 15 | |
| other | Conjunctivitis | Eye disorders | SD-101-6.0 to SD-101-6.0 | 0 | 10 | |
| other | Chalazion | Eye disorders | Placebo to SD-101-6.0 | 1 | 17 |
1 to 10 of 315Source ClinicalTrials.gov
See all 315 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo to SD-101-6.0 | 0 | 17 |
| Total, all-cause mortality | SD-101-3.0 to SD-101-6.0 | 0 | 15 |
| Total, all-cause mortality | SD-101-6.0 to SD-101-6.0 | 0 | 10 |
| Total, other adverse events | Placebo to SD-101-6.0 | 13 | 17 |
| Total, other adverse events | SD-101-3.0 to SD-101-6.0 | 13 | 15 |
| Total, other adverse events | SD-101-6.0 to SD-101-6.0 | 5 | 10 |
| Total, serious adverse events | Placebo to SD-101-6.0 | 4 | 17 |
| Total, serious adverse events | SD-101-3.0 to SD-101-6.0 | 2 | 15 |
| Total, serious adverse events | SD-101-6.0 to SD-101-6.0 | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD005093 | Phase 2 Study of SD-101 for the Treatment of Epidermolysis Bullosa | RYAN, ROBERT P | SCIODERM, INC. | FOOD AND DRUG ADMINISTRATION | 2015 |
Source NIH RePORTER
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/NCT02090283
GET https://conductscience.org/api/trials/v1/NCT02090283/events?page=2