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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03472287 |
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Date of registration:
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14/03/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)
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Scientific title:
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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) |
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Date of first enrolment:
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May 18, 2018 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03472287 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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France
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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Mary Spellman |
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Address:
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Telephone:
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Email:
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Affiliation:
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Castle Creek Pharmaceuticals, LLC |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- At least 12 years of age (Cohort 1) or at least 6 months of age to 11 years, inclusive
(Cohort 2) at screening. For US only: at least 4 years of age to 11 years, inclusive
(Cohort 2)
- The subject must weigh at least 9 kg (19.8 lbs) at Screening.
- Subject has a documented genetic mutation consistent with EB.
- Subject has EB lesions on = 2% body surface area (BSA) and the EB lesions are in the
following body areas: a. Localized: plantar and/or palmar areas, b. Generalized: arms,
legs, torso, hands and feet.
Key Exclusion Criteria:
- Subject has EB lesions where drug will be applied that are infected
- Subject has used any diacerein containing product within 1 month prior to Visit 1
- Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior
to dosing.
- Subject has used systemic steroidal therapy or has used topical steroidal therapy on
the EB lesions in the application area within 14 days prior to dosing
- Subject has participated in an investigational drug trial in which administration of
an investigational study medication occurred within 30 days prior to dosing
Age minimum:
4 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Junctional Epidermolysis Bullosa
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Dystrophic Epidermolysis Bullosa
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Epidermolysis Bullosa Simplex
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Epidermolysis Bullosa (EB)
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Intervention(s)
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Drug: Diacerein 1% Ointment
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Primary Outcome(s)
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Detectable Plasma Concentrations of Diacerein and Rhein
[Time Frame: Days 1-10, at select time points per protocol]
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Secondary ID(s)
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CCP-020-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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