NCT02090283 is a Phase 2 clinical trial of SD-101 dermal cream (6%) in Epidermolysis Bullosa, sponsored by Scioderm, Inc..

Who is sponsoring NCT02090283?

NCT02090283 is sponsored by Scioderm, Inc..

What drugs are being tested in NCT02090283?

Interventions in NCT02090283: SD-101 dermal cream (6%).

What condition does NCT02090283 study?

NCT02090283 studies Epidermolysis Bullosa.

Is NCT02090283 still recruiting?

NCT02090283 is currently terminated. Last updated 4 November 2019.

Are results published for NCT02090283?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-04 · How we verify

NCT02090283

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

Terminated Phase 2 Results posted Last updated 4 November 2019

What this trial tests

Phase 2 trial testing SD-101 dermal cream (6%) in Epidermolysis Bullosa in 42 participants. Terminated before completion.

Timeline

26 March 2014

Primary endpoint
14 September 2018

14 September 2018

Quick facts

Lead sponsor	Scioderm, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	26 March 2014
Primary completion	14 September 2018
Estimated completion	14 September 2018
Sites	7 locations across United States

Drugs / interventions tested

SD-101 dermal cream (6%) — full drug profile →

Conditions studied

Epidermolysis Bullosa — all drugs for Epidermolysis Bullosa →

Sponsor

Scioderm, Inc. — full company profile →

Who can join

6 Months 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 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.

Any TEAE

Group	Value	95% CI
Placebo to SD-101-6.0	13
SD-101-3.0 to SD-101-6.0	14
SD-101-6.0 to SD-101-6.0	5

Any TEAE Related to Study Drug

Group	Value	95% CI
Placebo to SD-101-6.0	1
SD-101-3.0 to SD-101-6.0	1
SD-101-6.0 to SD-101-6.0	0

Any Fatal TEAE

Group	Value	95% CI
Placebo to SD-101-6.0	0
SD-101-3.0 to SD-101-6.0	0
SD-101-6.0 to SD-101-6.0	0

Serious TEAE

Group	Value	95% CI
Placebo to SD-101-6.0	4
SD-101-3.0 to SD-101-6.0	2
SD-101-6.0 to SD-101-6.0	0

Any TEAE Leading to Discontinuation

Group	Value	95% CI
Placebo to SD-101-6.0	1
SD-101-3.0 to SD-101-6.0	1
SD-101-6.0 to SD-101-6.0	0

Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24 Secondary · 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 par

Group	Value	95% CI
Placebo to SD-101-6.0	1.99	± 6.728
SD-101-3.0 to SD-101-6.0	-3.73	± 6.152
SD-101-6.0 to SD-101-6.0	-9.50	± 21.248

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline (Day 0) to 30 days after last application of study drug (up to a maximum of 54 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo to SD-101-6.0

Serious: 4/17 (24%)

Deaths: 0/17

SD-101-3.0 to SD-101-6.0

Serious: 2/15 (13%)

Deaths: 0/15

SD-101-6.0 to SD-101-6.0

Serious: 0/10 (0%)

Deaths: 0/10

Serious adverse events (21 terms)

Reaction	System	Placebo to SD-101-6.0	SD-101-3.0 to SD-101-6.0	SD-101-6.0 to SD-101-6.0
Anaemia	Blood and lymphatic system disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Cyanosis	Cardiac disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Rhinovirus infection	Infections and infestations	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—
Staphylococcal infection	Infections and infestations	—	—	—
Tracheitis	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Major depression	Psychiatric disorders	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	—	—	—
Skin lesion	Skin and subcutaneous tissue disorders	—	—	—

Other adverse events (84 terms — click to expand)

Reaction	System	Placebo to SD-101-6.0	SD-101-3.0 to SD-101-6.0	SD-101-6.0 to SD-101-6.0
Pyrexia	General disorders	—	—	—
Skin infection	Infections and infestations	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Conjunctivitis	Eye disorders	—	—	—
Pain	General disorders	—	—	—
Ear infection	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Wound infection	Infections and infestations	—	—	—
Corneal abrasion	Injury, poisoning and procedural complications	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Tympanic membrane perforation	Ear and labyrinth disorders	—	—	—
Chalazion	Eye disorders	—	—	—
Dry eye	Eye disorders	—	—	—
Myopia	Eye disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—
Gastrointestinal obstruction	Gastrointestinal disorders	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—
Oesophageal perforation	Gastrointestinal disorders	—	—	—
Oesophageal stenosis	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Application site pain	General disorders	—	—	—
Developmental delay	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Peripheral swelling	General disorders	—	—	—
Gallbladder pain	Hepatobiliary disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—
Bacterial disease carrier	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Clostridium difficile infection	Infections and infestations	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Corona virus infection	Infections and infestations	—	—	—

Most-reported serious reactions: Anaemia, Lymphadenopathy, Bradycardia, Cyanosis, Abdominal pain, Gastrointestinal haemorrhage, Upper gastrointestinal haemorrhage, Pain.

Data from ClinicalTrials.gov NCT02090283 adverse events section.

Sponsor's own description

The purpose of this study was to assess the continued safety of topical use of SD-101 cream (6%) in participants with Epidermolysis Bullosa (EB). Funding Source: FDA Office of Orphan Products Development

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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.

NCT02670330 — Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bull · Phase 3 · terminated
NCT02384460 — ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa · Phase 3 · completed
NCT02014376 — Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02090283 (US National Library of Medicine, public domain)
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: 4 November 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/NCT02090283.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing