KeloidPhase 2NCT01446770
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
A Phase 2 study testing Hydrogel scaffold (MF-4181) in people with Keloid, run by Halscion, Inc. at 1 site in The Bahamas.
Trial summary
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Keloid
- What is being tested?
- Hydrogel scaffold (MF-4181)
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteThe Bahamas
- Study dates
- Nov 2010to Dec 2011
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
- Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
- Keloids that have been present for ≥ 1 year.
- The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
- Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
- Willing to comply with the follow up schedule for a minimum of 6 months.
Who cannot join
- Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
- Pregnant or planning to become pregnant during the course of the study.
- Heart disease or history of congestive heart failure.
- Advanced or poorly controlled diabetes.
- Current or history of heavy smoking (i.e., 10 pack years)
- Active local infection at the treatment site and/or systemic infection.
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- History of or active central nervous system disease.
- History of fever, migraine headaches, and/or recurrent upper respiratory infection.
- Active collagen vascular disease or vasculitis, e.g., systemic lupus erythematosus, polyarthritis, dermatomyositis, systemic scleroderma or thrombotic thrombocytopenic purpura.
- Unwilling or unable to return for follow-up visits.
- Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study, including steroid injections.
- Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated.
- Current participation or participation within the last 3 months in the study of an investigational drug, device, or biologic.
- Unable or unwilling to follow post-operative instructions.
- Known hypersensitivity to MF-4181, collagen, dextran, or any of its constituent materials.
- Known hypersensitivities to animal-based products
- Previous participation in this study to avoid multiple enrollments of an individual subject.
Trial locations and contacts
1 site in 1 country.
The Bahamas1 site
Princess Margaret Hospital
Nassau
About this study
Official title: A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
- Conditions
- Keloid
- Being tested
- Hydrogel scaffold (MF-4181)
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel scaffold (MF-4181)Device
Also called Hydrogel scaffold
Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
What is being measured
The primary outcome is the main question the study is designed to answer.
Device safety
Device safety is defined as the incidence of device related adverse events.
Measured: 6 months
Secondary outcomes (3)
Device efficacy
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
Measured: 12 months
Device efficacy
Volume and linear measurements will be taken by the investigator
Measured: 12 months
Device efficacy
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halscion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srikanth Garikaparthi, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446770
- Sponsor's protocol ID
- HAL-0127
- Status last verified
- Mar 2012
- First submitted
- 2 Oct 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Feasibility Study Evaluating the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181 Adjunctive to Surgical Scar Revision
- ClinicalTrials.gov ID
- NCT01446770
- Acronym / sponsor ID
- HAL-0127
- Conditions
- Keloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Halscion, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Oct 2011 (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.
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male or female subjects 15 to 50 years of age each having at least one keloid scar on the ear. (If both ears have keloids, both ears may be treated with E-Matrix).
- Keloids that have not undergone more than two surgical revisions (laser, cryotherapy or surgery)
- Keloids that have been present for ≥ 1 year.
- The keloid must measure ≥ 0.5 cm and not extend onto other portions of the head, neck, or face.
- Able and willing to give written informed consent. (Age 15-17 must have written informed consent of legal guardian).
Key exclusion criteria (17 listed)
- Subjects with history of prior treatment at the study site or prior treatment of the keloid in the previous 6 weeks.
- Pregnant or planning to become pregnant during the course of the study.
- Heart disease or history of congestive heart failure.
- Advanced or poorly controlled diabetes.
- Current or history of heavy smoking (i.e., 10 pack years)
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 |
|---|---|---|
| Hydrogel scaffold (MF-4181)Also: Hydrogel scaffoldFollowing surgical removal of the ear keloid, the incision will be treated with MF-4181. | Device | – |
Primary outcome
Device safety
Time frame: 6 months
Device safety is defined as the incidence of device related adverse events.
3 secondary outcomes
Device efficacy
Time frame: 12 months
Device efficacy
Time frame: 12 months
Device efficacy
Time frame: 12 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 13 Mar 2012.
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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.
Srikanth Garikaparthi, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrogel scaffold (MF-4181) in people with Keloid, run by Halscion, Inc. at 1 site in The Bahamas.
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 6 inclusion and 17 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Bahamas. 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?
Device safety (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 13 Mar 2012.