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NCT02384460 · ClinicalTrials.gov registry record · Phase 3

ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa

A Phase 3 study, sponsored by Scioderm.

Completed
Registry status
Phase 3
Development phase
169
Enrollment target

NCT02384460 is a Phase 3 study that has completed, run by Scioderm. The registered enrollment target is 169 participants.

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The verdict

NCT02384460, a Phase 3 study, has completed, sponsored by Scioderm.

COMPLETED
Registry status
Phase 3
Development phase
169 participants
Enrollment target

Study Summary

The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

Interventions

  • DRUG SD-101-6.0 cream
  • DRUG Placebo (SD-101-0.0) cream

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2015-03-11
Est. Completion 2017-07-05
Phase Phase 3

Sponsor

Scioderm

4 total trials

What the Registry Record Tells You About NCT02384460

The ClinicalTrials.gov registry entry for NCT02384460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scioderm, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which SD-101-6.0 cream is the first listed.

NCT02384460 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02384460 about?

NCT02384460 is a clinical study titled "ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa". The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

What is the current status of trial NCT02384460?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2015-03-11. Estimated completion is 2017-07-05.

What interventions are being tested in trial NCT02384460?

The interventions under investigation include: SD-101-6.0 cream (DRUG), Placebo (SD-101-0.0) cream (DRUG).

Who is sponsoring clinical trial NCT02384460?

This trial is sponsored by Scioderm, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.