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Long Term Open-label Study Evaluating Safety of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex

NCT03389308 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-09-16

Study results available
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Summary

The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.

Conditions

  • Epidermolysis Bullosa
  • Epidermolysis Bullosa Simplex

Interventions

DRUG

diacerein 1% ointment

Topically apply study medication to lesions identified by the Investigator that require. treatment

Sponsors & Collaborators

  • Castle Creek Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Mary Spellman, MD · Castle Creek Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-04-17
Completion
2020-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389308 on ClinicalTrials.gov