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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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2 August 2021 |
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Main ID: |
NCT02402309 |
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Date of registration:
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17/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
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Scientific title:
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Phase II Study of the Safety, Pharmacokinetics, and Exploratory Activity of Once Daily (QD) Topical Application of NS2 Cream to Treat Ichthyosis in Subjects With Sjögren-Larsson Syndrome (SLS) |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02402309 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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William B. Rizzo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nebraska |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Genetically-confirmed diagnosis of SLS
- Active ichthyosis on the lower extremities that is determined to be at least moderate
severity
Exclusion Criteria:
- Evidence of an active infection
- Currently receiving immunosuppressive therapy, including intermittent or low-dose
corticosteroids and is not able or willing to suspend from 2 weeks before and during
the study
- Currently receiving systemic or topical retinoids, other topically applied drugs, or
other supplements that could interfere with dermatologic examination findings
- Received an investigational systemic or topically administered drug within 30 days
before screening
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjögren-Larsson Syndrome
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Intervention(s)
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Drug: Vehicle placebo 0.0% NS2 dermatologic cream
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Drug: Active topical NS2 1% dermatologic cream
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Primary Outcome(s)
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Number of Participants with Adverse Events as a measure of Safety and Tolerability
[Time Frame: Week 8]
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Secondary Outcome(s)
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Pharmacokinetics - Peak Plasma Concentration (Cmax)
[Time Frame: Day 1, Day 2, Week 4, Week 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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