KeloidPhase 2NCT02079168
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
A Phase 2 study testing RXI-109 in people with Keloid, run by RXi Pharmaceuticals, Corp. at 3 sites in 2 countries.
Trial summary
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloid
- What is being tested?
- RXI-109
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Use of tobacco or nicotine-containing products
- Pregnant or lactating
- Post-menopausal or full hysterectomy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Study site
Miami, Florida, 33137
Study site
St Louis, Missouri, 63141
About this study
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
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
- Conditions
- Keloid
- Being tested
- RXI-109, Placebo
- Keywords
- Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy
- Medical subject headings
- Keloid, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RXI-109Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: RXI-109; Drug: Placebo |
| Cohort 2 | Experimental | 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. Receives: Drug: RXI-109; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the recurrence of a keloid after keloid excision
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision
Measured: 6 months
Secondary outcomes (1)
Safety of RXI-109
To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- RXi Pharmaceuticals, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Pavco, PhD, Study director, RXi Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079168
- Sponsor's protocol ID
- RXI-109-1401
- Status last verified
- Jun 2016
- First submitted
- 3 Mar 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02079168
- Acronym / sponsor ID
- RXI-109-1401
- Conditions
- Keloid
- Keywords
- Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- RXi Pharmaceuticals, Corp.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RXI-109, Drug: PlaceboTreatment 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. |
| Cohort 2 | Experimental | Drug: RXI-109, Drug: PlaceboTreatment 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. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Use of tobacco or nicotine-containing products
- Pregnant or lactating
- Post-menopausal or full hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RXI-109 | Drug | Cohort 1, Cohort 2 |
| Placebo | Drug | Cohort 1, Cohort 2 |
Primary outcome
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
1 secondary outcome
Safety of RXI-109
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Pavco, PhD study director
RXi Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RXI-109 in people with Keloid, run by RXi Pharmaceuticals, Corp. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the recurrence of a keloid after keloid excision (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.