1 Month and older, any sex, with Epidermolysis Bullosa. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number Of Participants With Treatment Emergent Adverse Events (TEAEs)Primary· From baseline to 30 days after last application of study drug (up to a maximum of 37 months)
TEAEs were defined as adverse events that started or worsened on or after baseline visit.
Any TEAE
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
51
Placebo to SD-101-6.0
58
Any TEAE Related To Study Drug
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
8
Placebo to SD-101-6.0
17
Any Fatal TEAE
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
0
Placebo to SD-101-6.0
0
Any Serious TEAE
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
11
Placebo to SD-101-6.0
14
Any TEAE Leading To Discontinuation
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
2
Placebo to SD-101-6.0
3
Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30Secondary· Baseline, up to Month 30
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, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSA for lesional skin was to be assessed by the same study phys
Month 1
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-0.76
± 4.185
Placebo to SD-101-6.0
-0.54
± 5.398
Month 3
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.87
± 5.999
Placebo to SD-101-6.0
-1.21
± 6.457
Month 6
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.77
± 6.015
Placebo to SD-101-6.0
-1.35
± 6.813
Month 9
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-2.48
± 9.436
Placebo to SD-101-6.0
0.31
± 10.117
Month 12
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-3.35
± 9.566
Placebo to SD-101-6.0
0.44
± 10.327
Month 15
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.90
± 7.337
Placebo to SD-101-6.0
2.15
± 12.546
Month 18
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-2.46
± 5.275
Placebo to SD-101-6.0
-4.24
± 8.207
Month 21
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-3.06
± 5.869
Placebo to SD-101-6.0
-1.58
± 10.442
Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30Secondary· Baseline, up to Month 30
A wound was defined as an open area on the skin (that is, epidermal covering disrupted). Total body wound burden was calculated using BSAI; the percentage, ranging from 0% to 100%, of affected 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, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSAI for total body wound burden was to be assessed by the same study physician at each visit for a particular participant.
The mean change from baseline
Month 1
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.75
± 4.891
Placebo to SD-101-6.0
0.07
± 4.044
Month 3
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.52
± 5.343
Placebo to SD-101-6.0
-0.80
± 3.001
Month 6
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.54
± 4.322
Placebo to SD-101-6.0
-0.48
± 3.595
Month 9
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.82
± 6.083
Placebo to SD-101-6.0
-0.42
± 3.586
Month 12
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.38
± 5.497
Placebo to SD-101-6.0
-0.13
± 3.211
Month 15
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-0.15
± 4.511
Placebo to SD-101-6.0
0.26
± 3.030
Month 18
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.12
± 3.053
Placebo to SD-101-6.0
-1.31
± 4.665
Month 21
Group
Value
95% CI
SD-101-6.0 to SD-101-6.0
-1.44
± 3.150
Placebo to SD-101-6.0
-0.28
± 5.507
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline to 30 days after last application of study drug (up to a maximum of 37 months)..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT02384460 — ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
· Phase 3
· completed
Other recruiting trials for Epidermolysis Bullosa
Currently open trials in the same condition.
NCT06330350 — Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling
· recruiting
NCT05725018 — A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patien
· Phase 3
· active not recruiting
Other Scioderm, Inc. trials
Trials by the same sponsor.
NCT02384460 — ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
· Phase 3
· completed
NCT02090283 — Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
· Phase 2
· terminated
NCT02014376 — Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
· Phase 2
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Scioderm, Inc.
Last refreshed: 27 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02670330.