Completed PHASE3 INTERVENTIONAL 2-arm NCT02384460

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

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa

Sponsor: Amicus Therapeutics

Conditions Epidermolysis Bullosa

Interventions Placebo (SD-101-0.0) cream SD-101-6.0 cream

Updated 12 times since 2017 Last updated: Apr 1, 2020 Started: Mar 11, 2015 Primary completion: Jul 5, 2017 Completion: Jul 5, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Epidermolysis Bullosa and is currently completed. Amicus Therapeutics leads this study, which shows 12 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

12 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
May 2020 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 7 earlier versions

Dec 2018 — May 2020 [monthly]

Completed PHASE3
Nov 2018 — Dec 2018 [monthly]

Completed PHASE3
Jun 2018 — Nov 2018 [monthly]

Completed PHASE3
Aug 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
May 2017 — Aug 2017 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Feb 2017 — May 2017 [monthly]

Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Mar 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Amicus Therapeutics
Scioderm, Inc.

Data source: Scioderm, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Austin, United States , Belgrade, Serbia , Chapel Hill, United States , Charleston, United States , Chicago, United States , Cincinnati, United States , Columbia, United States , East Setauket, United States , Freiburg im Breisgau, Germany and 26 more locations