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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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19 February 2015 |
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Main ID: |
NCT01780077 |
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Date of registration:
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28/01/2013 |
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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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Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
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Scientific title:
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A Phase 1 Single Center, Randomized, Double-Blind, Ascending, Multi-Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Abdominal Skin of Healthy Subjects |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01780077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Honduras
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females, 21-50 years of age
- General good health; if female not pregnant or lactating
- Phototype 3 and above based on the Fitzpatrick scale.
Exclusion Criteria:
- Pregnant or lactating
- Use of tobacco or nicotine-containing products within 1 month prior to enrollment and
while on study
- Type 1 or 2 diabetes mellitus
- A history or presence of any medical condition or therapy that would make the subject
an unsafe candidate in the opinion of the investigator
Age minimum:
21 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cicatrix
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Scar Prevention
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Intervention(s)
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Drug: RXI-109
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Drug: Placebo
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Primary Outcome(s)
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To assess the safety and tolerability of multiple intradermal administrations of RXI-109
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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To assess the effect of multiple intradermal administrations of RXI-109 on scar formation
[Time Frame: 12 weeks]
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Secondary ID(s)
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RXI-109-1202
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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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