Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

RXi Pharmaceuticals, Corp.

ClinicalTrials.gov Identifier:

NCT01640912

First received: July 12, 2012

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 12, 2012
Last Updated Date	October 10, 2012
Start Date ^ICMJE	June 2012
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 12, 2012)	To assess the safety and tolerability of intradermal administration of RXI-109 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01640912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 12, 2012)	To assess the effect of RXI-109 on scar formation following small surgical incisions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Official Title ^ICMJE	A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty
Brief Summary	The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Cicatrix Scar Prevention
Intervention ^ICMJE	Drug: RXI-109 Single intradermal injection of RXI-109 at incision sites Drug: Placebo Single intradermal injection of placebo at incision sites
Study Arm (s)	Experimental: RXI-109 Intervention: Drug: RXI-109 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	March 2013
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject must be a female in general good health with normal screening values Subject must be a good surgical candidate for an elective abdominoplasty Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists) Exclusion Criteria: Currently pregnant or lactating BMI greater than 35 at screening Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI
Gender	Female
Ages	21 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01640912
Other Study ID Numbers ^ICMJE	RXI-109-1201
Has Data Monitoring Committee	Yes
Responsible Party	RXi Pharmaceuticals, Corp.
Study Sponsor ^ICMJE	RXi Pharmaceuticals, Corp.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	RXi Pharmaceuticals, Corp.
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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