KeloidPhase 1/2NCT00587587
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
A Phase 1/2 study testing Apligraf and Standard dressing regimen in people with Keloid, run by Organogenesis at 1 site in United States.
Trial summary
This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keloid
- What is being tested?
- Apligraf and Standard dressing regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 18 and 65 years of age.
- Subject or legal guardian has read, understood, and signed appropriate Institutional Review Board (IRB) approved informed consent, photography release form and HIPAA consent in their own language.
- Subject with 1 keloid measuring between 1 cm2 - 40 cm2 as assessed by the Investigator, present for at least 6 months and a Beausang Scar scale combined score of 5 or greater.
- Subject is a male or female who must have a documented negative urine pregnancy test if of child bearing potential. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
- Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
- Subject and/or legal guardian must be able and willing to return for follow-up study visits.
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- Subject agrees to not use a keloid medication or injection treatment for four weeks prior to Day 0.
- Subject agrees not to use any other keloid treatments for the duration of the study.
- Subject is otherwise healthy as assessed and determined by the Investigator
Who cannot join
- Subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the Investigator could influence the results of the study.
- Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, HbA1C > 10%), cancer (biopsy confirming active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
- Subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema.
- Subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. Inhaled steroid therapy is acceptable.
- Subject with the presence of acute infections in the areas intended for treatment.
- Subject with known hypersensitivity to bovine collagen or to the components of the Apligraf agarose shipping medium.
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- Subject who is lactating or pregnant (positive result as determined by urine testing).
- Subject with liver (ALT/SGPT, ALP, AST/SGOT, bilirubin, albumin, total protein, LDH) and/or renal function (BUN and creatinine) tests > 2 x upper limit of normal (ULN).
- Subject who has been previously enrolled in any wound or investigational device study for any disease within the past four weeks.
- Subject who has received an investigational drug or biological treatment within the past three months.
- Subject previously treated with Apligraf, Dermagraft or any other cell therapy at the target keloid site.
- Subject with a history of alcohol or substance abuse within the previous year, which could interfere with study compliance such as inability to attend scheduled study visits or compliance with home dressing changes.
- Subject with a history of anaphylaxis.
- Subject who, in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Miami Beach, Florida, 33140
About this study
Official title: A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.
- Conditions
- Keloid
- Being tested
- Apligraf, Standard dressing regimen
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApligrafDevice
Application at Day 0, potential re-application at Week 4
Standard dressing regimenOther
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Apligraf (bilayered living cell therapy) Receives: Device: Apligraf |
| B | Active comparator | Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary Receives: Other: Standard dressing regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Summary of all reported adverse events (AE) in the intent to treat (ITT) population.
AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
Measured: 52 weeks
Secondary outcomes (7)
Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported.
BSS is a composite score where the individual scores from the following categories are summed:
Color (rated 1[perfect]-4[gross mismatch]), Shine (1/Matte or 2/Shiny), Contour (rated 1[flush with surrounding skin]-4[keloid]), Distortion (rated 1[None]-4[severe]), Texture (rated 1[normal]-4[hard]), and Overall Assessment on a 10cm visual analog scale (rated 0[excellent scar]-10 [poor scar]).
Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar).
Measured: Baseline to Week 52 or Last Visit
Cumulative Incidence of Keloid Recurrence at Week 52
Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.
Measured: 52 weeks
Degree of Recurrence (Scar Firmness)
Scar firmness measured by Cutometer in millimeters.
Measured: Week 52 or Last Visit
Degree of Recurrence (Scar Thickness)
Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.
Measured: Week 52 or Last visit
Physician Global Assessment
Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Measured: Week 52 or Last Visit
Subject Global Assessment
Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Measured: Week 52 or Last Visit
Decreased Utilization of Intralesional Steroid Intervention
The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Heather Woolery-Lloyd, MD, Principal investigator, University of Miami, Miller School of Medicine, Division of Cosmetic DermatologyDamien Bates, MD, PhD, FRACS (Plast.), Study director, Organogenesis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587587
- Sponsor's protocol ID
- 06-KEL-001-AG
- Status last verified
- Aug 2011
- First submitted
- 21 Dec 2007
- Last updated
- 19 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
- ClinicalTrials.gov ID
- NCT00587587
- Acronym / sponsor ID
- 06-KEL-001-AG
- Conditions
- Keloid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 19 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: ApligrafApligraf (bilayered living cell therapy) |
| B | Active comparator | Other: Standard dressing regimenDressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is between 18 and 65 years of age.
- Subject or legal guardian has read, understood, and signed appropriate Institutional Review Board (IRB) approved informed consent, photography release form and HIPAA consent in their own language.
- Subject with 1 keloid measuring between 1 cm2 - 40 cm2 as assessed by the Investigator, present for at least 6 months and a Beausang Scar scale combined score of 5 or greater.
- Subject is a male or female who must have a documented negative urine pregnancy test if of child bearing potential. Sexually active females must be practicing a medically proven form of contraception during the course of the study period.
- Subject and/or legal guardian must be able and willing to follow study procedures and instructions.
Key exclusion criteria (14 listed)
- Subject is suffering from a condition likely to require medical attention, including administration of any treatment which in the opinion of the Investigator could influence the results of the study.
- Subject with any systemic condition like uncontrolled diabetes mellitus (glycosylated hemoglobin, HbA1C > 10%), cancer (biopsy confirming active malignancy), positive HIV test, or any disorder(s) that may compromise wound healing.
- Subject is suffering from an abnormal skin condition on the affected area not usually associated with keloids such as psoriasis, or eczema.
- Subject who is currently or has received topical or systemic steroid medication therapy within the past four weeks affecting the course of the keloid and/or its evaluability. Inhaled steroid therapy is acceptable.
- Subject with the presence of acute infections in the areas intended for treatment.
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 |
|---|---|---|
| ApligrafApplication at Day 0, potential re-application at Week 4 | Device | A |
| Standard dressing regimenA primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary | Other | B |
Primary outcome
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Time frame: 52 weeks
Summary of all reported adverse events (AE) in the intent to treat (ITT) population. AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
7 secondary outcomes
Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
Time frame: Baseline to Week 52 or Last Visit
Cumulative Incidence of Keloid Recurrence at Week 52
Time frame: 52 weeks
Degree of Recurrence (Scar Firmness)
Time frame: Week 52 or Last Visit
Degree of Recurrence (Scar Thickness)
Time frame: Week 52 or Last visit
Physician Global Assessment
Time frame: Week 52 or Last Visit
Subject Global Assessment
Time frame: Week 52 or Last Visit
Decreased Utilization of Intralesional Steroid Intervention
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Heather Woolery-Lloyd, MD principal investigator
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology
Damien Bates, MD, PhD, FRACS (Plast.) study director
Organogenesis Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apligraf and Standard dressing regimen in people with Keloid, run by Organogenesis at 1 site in United States.
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 9 inclusion and 14 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 19 Aug 2011. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 19 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented. (time frame: 52 weeks). 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 19 Aug 2011.