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)
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.
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.
;
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 |