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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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4 July 2016 |
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Main ID: |
NCT02030275 |
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Date of registration:
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06/01/2014 |
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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 to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
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Scientific title:
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A Multi-Center, Prospective, Randomized, Double-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery on Transverse Hypertrophic Scars on the Lower Abdomen Resulting From Previous Surgeries in Healthy Adults |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02030275 |
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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/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Honduras
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United States
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Contacts
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Name:
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Pamela Pavco, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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RXi Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults, 21-55 years of age in general good health
- Previous partial hysterectomy, Cesarean section or abdominoplasty surgery resulting
in a transverse hypertrophic scar of = 11 cm in length
- Scar to be revised must have been present for > 9 months
Exclusion Criteria:
- Use of tobacco or nicotine-containing products
- Pregnant or lactating
- Post-menopausal or full hysterectomy
Age minimum:
21 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertrophic Scar
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Intervention(s)
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Drug: Placebo
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Drug: RXI-109
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Primary Outcome(s)
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Reduction in recurrence of hypertrophic scarring after scar revision surgery
[Time Frame: 9 months]
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Secondary Outcome(s)
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Safety of RXI-109
[Time Frame: 9 months]
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Secondary ID(s)
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RXI-109-1301
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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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