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Trial record 6 of 11 for:    rxi

A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02079168
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
RXi Pharmaceuticals, Corp.

Brief Summary:
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Condition or disease Intervention/treatment Phase
Keloid Drug: RXI-109 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Cohort 1
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.
Drug: RXI-109
Drug: Placebo
Experimental: Cohort 2
Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.
Drug: RXI-109
Drug: Placebo



Primary Outcome Measures :
  1. Reduction in the recurrence of a keloid after keloid excision [ Time Frame: 6 months ]
    To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision


Secondary Outcome Measures :
  1. Safety of RXI-109 [ Time Frame: 6 months ]
    To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults, 21-55 years of age.
  • Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.
  • Keloids to be excised must have been present for > 1 year.

Exclusion Criteria:

  • Use of tobacco or nicotine-containing products
  • Pregnant or lactating
  • Post-menopausal or full hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079168


Locations
United States, Florida
Miami, Florida, United States, 33137
United States, Missouri
St. Louis, Missouri, United States, 63141
Dominican Republic
San Cristobal, Dominican Republic
Sponsors and Collaborators
RXi Pharmaceuticals, Corp.
Investigators
Study Director: Pamela Pavco, PhD RXi Pharmaceuticals

Responsible Party: RXi Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT02079168     History of Changes
Other Study ID Numbers: RXI-109-1401
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by RXi Pharmaceuticals, Corp.:
Keloid
Cicatrix
Keloid prevention
Keloid revision/excision
Keloidectomy

Additional relevant MeSH terms:
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes