Clinical Trials Logo
  1. Home
  2. Epidermolysis Bullosa Simplex
  3. NCT03472287

To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:
A Multi-Center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein After Maximum Use, Topical Administration of CCP-020 (Diacerein 1% Ointment) to Patients With Epidermolysis Bullosa (EB)

Clinical Trial Summary

A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.

Clinical Trial Description

This was an open-label, single-period study that intended to include subjects with EB consisting of infants/ children (ages 6 months to 11 years, inclusive) and adolescents/ adults (ages 12 years and older). The study included 2 cohorts.

Cohort 1 was to include adolescent/adult subjects with EB (ages 12 years and older);

Cohort 2 was to include infants/children with EB (ages 4 to 11 years, inclusive).

For both cohorts, the study intended to enroll subjects with epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), and junctional epidermolysis bullosa (JEB) with lesions encompassing >/=2% BSA. The diacerein application area was >/=5% BSA and included lesioned and non-lesioned skin (if lesions accounted for <5% BSA); however, topical administration was </=30% BSA. On Days 1 and 10, the topical dose of study drug was applied by study staff, and blood was sampled for PK analyses of diacerein and rhein pre-dose and through 8 hours post-application. On Days 2 to 9, study drug was applied to the application area(s) at home. For Cohort 1, trough PK samples were collected on any 2 available days from Days 3 through 9, and study drug was applied after blood draw, while for Cohort 2 trough PK analyses were not performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03472287
Study type Interventional
Source Castle Creek Pharmaceuticals, LLC
Contact
Status Completed
Phase Phase 1
Start date May 18, 2018
Completion date February 14, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03536143 - A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients Phase 1/Phase 2
Recruiting NCT04917887 - Long-Term Follow-up Protocol
Completed NCT04917874 - A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa Phase 3
Terminated NCT03578029 - Evaluation of the Safety and Efficacy Study of RGN-137 Topical Gel for Junctional and Dystrophic Epidermolysis Bullosa Phase 2
Recruiting NCT05157958 - Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis Bullosa Phase 2
Withdrawn NCT01528306 - A Pilot Study of HP802-247 in Dystrophic Epidermolysis Bullosa Phase 2
Completed NCT02178969 - Short Term Observational Study in DEB Patients
Withdrawn NCT04214002 - The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Recruiting NCT04757727 - Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)
Withdrawn NCT01768026 - Prospective, Longitudinal Natural History Study in Dystrophic Epidermolysis Bullosa N/A
Completed NCT01538862 - Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa N/A
Completed NCT03183934 - A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
Completed NCT02579369 - Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa Phase 1/Phase 2
Withdrawn NCT02004600 - Pilot Study Evaluating the Efficiency and the Tolerance of the PDT in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary DEB N/A
Completed NCT04491604 - Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB Phase 3
Not yet recruiting NCT05529134 - Study of PTW-002 in Patients With Dominant or Recessive Dystrophic Epidermolysis Bullosa Due to Mutation(s) in Exon 73 of the COL7A1 Gene Phase 1/Phase 2
Not yet recruiting NCT04173650 - MSC EVs in Dystrophic Epidermolysis Bullosa Phase 1/Phase 2