NCT01640912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.8 years

First QC Date

July 12, 2012

Last Update Submit

September 16, 2014

Conditions

CicatrixScar Prevention

Keywords

ScarScar preventionFibrosis

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of intradermal administration of RXI-109

    Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities

    12 weeks

Secondary Outcomes (1)

  • To assess the effect of RXI-109 on scar formation following small surgical incisions

    12 weeks

Study Arms (2)

RXI-109

EXPERIMENTAL
Drug: RXI-109

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RXI-109DRUG

Single intradermal injection of RXI-109 at incision sites

RXI-109
PlaceboDRUG

Single intradermal injection of placebo at incision sites

Placebo

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

CicatrixFibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 16, 2012

Study Start

June 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

US(1)