Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109
This study is currently recruiting participants.
Verified January 2013 by RXi Pharmaceuticals, Corp.
Sponsor:
RXi Pharmaceuticals, Corp.
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier:
NCT01780077
First received: January 28, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.
| Condition | Intervention | Phase |
|---|---|---|
|
Cicatrix Scar Prevention |
Drug: RXI-109 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by RXi Pharmaceuticals, Corp.:
Primary Outcome Measures:
- To assess the safety and tolerability of multiple intradermal administrations of RXI-109 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Evaluate safety and tolerability of multiple administrations of RXI-109 at the site of intradermal injection. Examine and assess any and all local and systemic toxicities
Secondary Outcome Measures:
- To assess the effect of multiple intradermal administrations of RXI-109 on scar formation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Assess visual outcome and histology of scars. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and scored.
Other Outcome Measures:
- To assess the timeline and levels of biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Analysis of immunohistochemical analysis of biomarkers common to the scar formation pathway.
| Estimated Enrollment: | 12 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RXI-109 |
Drug: RXI-109
Multiple intradermal injections of RXI-109 at incision sites
Drug: Placebo
Multiple intradermal injections of placebo at incision sites
|
| Placebo Comparator: Placebo |
Drug: RXI-109
Multiple intradermal injections of RXI-109 at incision sites
Drug: Placebo
Multiple intradermal injections of placebo at incision sites
|
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780077
Contacts
| Contact: Pamela Pavco, PhD | ppavco@rxipharma.com |
Locations
| Honduras | |
| Recruiting | |
| San Pedro Sula, Cortes, Honduras, 21104 | |
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
More Information
No publications provided
| Responsible Party: | RXi Pharmaceuticals, Corp. |
| ClinicalTrials.gov Identifier: | NCT01780077 History of Changes |
| Other Study ID Numbers: | RXI-109-1202 |
| Study First Received: | January 28, 2013 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by RXi Pharmaceuticals, Corp.:
|
Scar Scar prevention Fibrosis |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013