Trial · NCT02384460
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
NCT02384460, Phase 3, Completed, Scioderm, Inc.; results first posted 2018-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa. Trials, record NCT02384460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02384460
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
- NCT number
- NCT02384460
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- Scioderm, Inc.
- Conditions
- Epidermolysis Bullosa
- Interventions
- SD-101-6.0 cream, Placebo (SD-101-0.0) cream
- First posted
- 2015-03-10
- Last updated
- 2020-04-09
- Other registries' IDs
- eudract:2014-002288-14
- Results first posted
- 2018-10-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time To Complete Target Wound Closure Within 3 Months | From baseline to Month 3 visit | Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Time to target wound closure was measured from the date of the first administration of the study drug to the date of target wound closure. Participants were censored if they did not have a response within 3 months, or withdrew earlier before the confirmation of their target wound closing. This primary end point displays the mean time to complete target wound closure, analyzed using a Kaplan-Meier approach. |
| Primary | The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months | From baseline to Month 3 visit | Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Participants were considered responders if they experienced complete wound closure at the Week 2 or Months 1, 2, or 3 visits. If a target wound was documented to have closed at a given visit, it was considered closed at all subsequent visits. This primary end point displays the percentage of participants from the ITT population who had complete target wound closure by the end of the study period (that is, 3 months). Analysis was performed on participants with post-baseline wound closure data. |
| Secondary | Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | From baseline to Month 1 and Month 2 visits | Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. The percentage of participants who completed target wound closure at the Month 1 and Month 2 study visits is displayed. If a target wound was documented to have closed at a given visit, it was considered closed at all subsequent visits. |
| Secondary | Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 3 Visit | Baseline, Month 3 visit | 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. BSAI was calculated as a percentage, ranging from 0% to 100%, of affected body surface area, recorded for each defined body region (that is, head/neck, upper limbs, trunk \[includes groin\], and lower limbs), multiplied by the weighting factor, then summed for all body regions. |
| Secondary | Change From Baseline In BSAI Of Total Body Wound Burden At Month 3 Visit | Baseline, Month 3 visit | Total body wound burden was calculated using BSAI. A wound defined as an open area on the skin (that is, epidermal covering disrupted). BSAI was calculated as a percentage, ranging from 0% to 100%, of affected body surface area, recorded for each defined body region (that is, head/neck, upper limbs, lower limbs, trunk \[includes groin\]), and multiplied by the weighting factor, then summed for all body regions. |
| Secondary | Change From Baseline In Itching Score At Day 7 | Baseline, Day 7 | Itching was assessed using the 5-point Itch Man Pruritus Assessment Tool. For participants up to 5 years of age, itching was assessed using caretaker's response and participants 6 years of age and older self-reported their itching assessments based on the following scores: 0=Comfortable, no itch; 1=itches a little, does not interfere with activity; 2=itches more, sometimes interferes with activity; 3=itches a lot, difficult to be still, concentrate; 4=itches most terribly, impossible to sit still or concentrate. Itching scores were categorized into 3 groups based on improvement; Improved or No Itching, Not Improved, and Missing. An itching score reduction from baseline greater than or equal to 1 point on the scale was classed as improved. |
| Secondary | Change From Baseline In Pain Score At Day 7 | Baseline, Day 7 | Change in pain assessed at Day 7 compared to baseline was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) behavioral scale for participants 1 month to 3 years of age. Each of the 5 FLACC categories was scored from 0 to 2, which resulted in a total score between 0 and 10 with 0=Relaxed and comfortable, 1 to 3=Mild discomfort, 4 to 6=Moderate pain, and 7 to 10=Severe discomfort/pain. For participants 4 years of age and older, the "Wong Faces Pain Scale" was used. This scale shows a series of faces ranging from a happy face at 0, which represents "no hurt," to a crying face at 10, which represents "hurts worst". Pain scores were categorized into 3 groups based on improvement: Improved or No Pain, Not Improved, and Missing. A pain score reduction from baseline greater than or equal to 2 points on the scale was classed as improved. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time To Complete Target Wound Closure Within 3 Months | From baseline to Month 3 visit | ITT population with post-baseline wound closure data and whose target wound had closed within 3 months. | days | MEAN |
| PRIMARY | The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months | From baseline to Month 3 visit | ITT population with post-baseline wound closure data and whose target wound had closed within 3 months. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | From baseline to Month 1 and Month 2 visits | Analysis was performed on participants from the ITT population with post-baseline wound closure data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 3 Visit | Baseline, Month 3 visit | Analysis was performed on the ITT population. The ITT population included all randomized participants. | Percentage change in BSAI | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In BSAI Of Total Body Wound Burden At Month 3 Visit | Baseline, Month 3 visit | Analysis was performed on the ITT population. The ITT population included all randomized participants. | Percentage change in BSAI | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Itching Score At Day 7 | Baseline, Day 7 | Analysis was performed on the ITT population. The ITT population included all randomized participants. | units on a scale | MEAN |
| SECONDARY | Change From Baseline In Pain Score At Day 7 | Baseline, Day 7 | Analysis was performed on the ITT population. The ITT population included all randomized participants. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time To Complete Target Wound Closure Within 3 Months | SD-101-6.0 Cream | 41.6 | Standard Deviation 25.50 | days | |
| Time To Complete Target Wound Closure Within 3 Months | Placebo (SD-101-0.0) Cream | 53.6 | Standard Deviation 28.59 | days | |
| The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months | SD-101-6.0 Cream | 49.4 | percentage of participants | ||
| The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months | Placebo (SD-101-0.0) Cream | 53.6 | percentage of participants | ||
| Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | SD-101-6.0 Cream | Month 1 | 31.6 | percentage of participants | |
| Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | Placebo (SD-101-0.0) Cream | Month 1 | 22.6 | percentage of participants | |
| Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | SD-101-6.0 Cream | Month 2 | 43.0 | percentage of participants | |
| Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits | Placebo (SD-101-0.0) Cream | Month 2 | 42.9 | percentage of participants | |
| Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 3 Visit | SD-101-6.0 Cream | -4.637 | Standard Error 1.404 | Percentage change in BSAI | |
| Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 3 Visit | Placebo (SD-101-0.0) Cream | -5.319 | Standard Error 1.354 | Percentage change in BSAI |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SD-101-6.0 Cream | 82 | |
| Overall Study | STARTED | Placebo (SD-101-0.0) Cream | 87 | |
| Overall Study | Received at Least 1 Dose of Study Drug | SD-101-6.0 Cream | 82 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo (SD-101-0.0) Cream | 87 | |
| Overall Study | COMPLETED | SD-101-6.0 Cream | 75 | |
| Overall Study | COMPLETED | Placebo (SD-101-0.0) Cream | 80 | |
| Overall Study | NOT COMPLETED | SD-101-6.0 Cream | 7 | |
| Overall Study | NOT COMPLETED | Placebo (SD-101-0.0) Cream | 7 |
Source ClinicalTrials.gov
Adverse events74
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 | Anemia | Blood and lymphatic system disorders | SD-101-6.0 Cream | 3 | 82 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo (SD-101-0.0) Cream | 2 | 87 | |
| other | Vomiting | Gastrointestinal disorders | SD-101-6.0 Cream | 2 | 82 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (SD-101-0.0) Cream | 2 | 87 | |
| other | Pain | General disorders | SD-101-6.0 Cream | 1 | 82 | |
| other | Pain | General disorders | Placebo (SD-101-0.0) Cream | 4 | 87 | |
| other | Pyrexia | General disorders | SD-101-6.0 Cream | 5 | 82 | |
| other | Pyrexia | General disorders | Placebo (SD-101-0.0) Cream | 9 | 87 | |
| other | Ear infection | Infections and infestations | SD-101-6.0 Cream | 1 | 82 | |
| other | Ear infection | Infections and infestations | Placebo (SD-101-0.0) Cream | 4 | 87 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SD-101-6.0 Cream | 0 | 82 |
| Total, all-cause mortality | Placebo (SD-101-0.0) Cream | 1 | 87 |
| Total, other adverse events | SD-101-6.0 Cream | 49 | 82 |
| Total, other adverse events | Placebo (SD-101-0.0) Cream | 46 | 87 |
| Total, serious adverse events | SD-101-6.0 Cream | 4 | 82 |
| Total, serious adverse events | Placebo (SD-101-0.0) Cream | 8 | 87 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SD-101-6.0 Cream vs Placebo (SD-101-0.0) Cream: deaths from any cause | Trial comparisons |
| SD-101-6.0 Cream vs Placebo (SD-101-0.0) Cream: serious adverse events | Trial comparisons |
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/NCT02384460
GET https://conductscience.org/api/trials/v1/NCT02384460/events?page=2