KeloidNCT00519493
A Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
A study testing Suture and Clozex in people with Keloid, run by University of Miami at 1 site in United States.
Trial summary
This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Suture and Clozex
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2007
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or females, in good health, and at least 12 years of age.
- Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length.
- Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent.
- In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure.
- In the opinion of the investigator, the keloid could benefit from surgical procedure.
Who cannot join
- Individuals with keloids that do not fit into the criteria.
- Individuals who are planning pregnancy, pregnant, or breast feeding.
- Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol.
- Individuals who present with excessive body hair in the designed keloid area.
- Individuals with uncontrolled diabetes.
- Individuals with autoimmune disorders (HIV/AIDs, SLE).
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- Subjects who have received keloid treatment within one month of the first day of the study.
- Individuals who plan to receive keloid treatment(s) during the study.
- Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications include, but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part Study: An Investigator-initiated, Single-center, Single-blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Each qualified subject will be assessed and the keloids will be randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. A second keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. The inflammation index and the keloid recurrence rate at each surgical wound closure site will be compared.
Read the detailed description
This study will be undertaken to compare the efficacy of two closure techniques for excised keloids. (1) Clozex, a non-latex, hypoallergenic adhesive polymeric interlaced film designed to adhere to proximal wound edges for 7-10 days, will be used after the punch biopsy or excision of a keloid and (2) sutures to close a similar second keloid after the punch biopsy or excision of a keloid.
On day 12, the investigator and subject will assess the keloid site(s) with the use of a visual analog scale.
There is an optional follow-up at 3 months and 6 months to assess the recurrence of the keloid and the effectiveness of the treatments with a visual analog scale.
The subject will assess the keloid site(s) with the use of the following visual analog scale:
- Cosmetic appearance
- Pain
- Tenderness
- Itching
- Oozing
- Redness
- Warmth
The investigator will assess the keloid site(s) with the use of this visual analog scale:
- Global appearance
- Color
- Matte/Shiny
- Contour
- Distortion
- Texture
- Oozing
- Redness
- Warmth
- Firmness
- Conditions
- Keloid
- Being tested
- Suture, Clozex
- Keywords
- Clozex, Sutures
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureProcedure or surgery
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures.
ClozexDevice
One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex.
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | A keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. Receives: Procedure: Suture |
| Clozex | Active comparator | One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. Receives: Device: Clozex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global appearance at Keloid site.
Measured: 12 (+/-2) days after excision of keloid
Secondary outcomes (2)
Global appearance at Keloid site.
Measured: 3 months (+/-3 weeks)
Global appearance at Keloid site.
Measured: 6 months (+/-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Issues with application of Clozex intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Brian Berman, M.D., Ph.D., Principal investigator, University of Miami Department of Dermatology and Cutaneous Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519493
- Sponsor's protocol ID
- 20061027
- Status last verified
- Mar 2019
- First submitted
- 21 Aug 2007
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998 Nov;102(6):1954-61. doi: 10.1097/00006534-199811000-00022.
PubMed 9810991
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Study: An Investigator-initiated, Single-center, Single-blinded, Randomized Clinical Study Comparing Two Closure Techniques of Excised Keloids
- ClinicalTrials.gov ID
- NCT00519493
- Acronym / sponsor ID
- 20061027
- Conditions
- Keloid
- Keywords
- Clozex, Sutures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with application of Clozex intervention
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Aug 2007 (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.
This investigator initiated study, single-blinded, parallel, randomized study will be conducted in subjects with 2 or more keloids similar in size and duration on a similar area of the body. The response of the closure techniques will be evaluated by clinical and instrumental assessments. Each qualified subject will be assessed and the keloids will be randomly assigned to the Clozex or suture closure. One keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. A second keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. The inflammation index and the keloid recurrence rate at each surgical wound closure site will be compared.
Detailed description
This study will be undertaken to compare the efficacy of two closure techniques for excised keloids. (1) Clozex, a non-latex, hypoallergenic adhesive polymeric interlaced film designed to adhere to proximal wound edges for 7-10 days, will be used after the punch biopsy or excision of a keloid and (2) sutures to close a similar second keloid after the punch biopsy or excision of a keloid.
On day 12, the investigator and subject will assess the keloid site(s) with the use of a visual analog scale.
There is an optional follow-up at 3 months and 6 months to assess the recurrence of the keloid and the effectiveness of the treatments with a visual analog scale.
The subject will assess the keloid site(s) with the use of the following visual analog scale:
- Cosmetic appearance
- Pain
- Tenderness
- Itching
- Oozing
- Redness
- Warmth
The investigator will assess the keloid site(s) with the use of this visual analog scale:
- Global appearance
- Color
- Matte/Shiny
- Contour
- Distortion
- Texture
- Oozing
- Redness
- Warmth
- Firmness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: SutureA keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. |
| Clozex | Active comparator | Device: ClozexOne keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or females, in good health, and at least 12 years of age.
- Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length.
- Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent.
- In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure.
- In the opinion of the investigator, the keloid could benefit from surgical procedure.
Key exclusion criteria (9 listed)
- Individuals with keloids that do not fit into the criteria.
- Individuals who are planning pregnancy, pregnant, or breast feeding.
- Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol.
- Individuals who present with excessive body hair in the designed keloid area.
- Individuals with uncontrolled diabetes.
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 |
|---|---|---|
| SutureOne keloid will be surgically excised and the surgical wound generated will be randomized to be closed with sutures. | Procedure or surgery | Suture |
| ClozexOne keloid will be surgically excised and the surgical wound generated will be randomized to be closed with Clozex. | Device | Clozex |
Primary outcome
Global appearance at Keloid site.
Time frame: 12 (+/-2) days after excision of keloid
2 secondary outcomes
Global appearance at Keloid site.
Time frame: 3 months (+/-3 weeks)
Global appearance at Keloid site.
Time frame: 6 months (+/-4 weeks)
Results and safety
The study was stopped early (reason given: Issues with application of Clozex intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Background: PubMed 9810991Beausang E, Floyd H, Dunn KW, Orton CI, Ferguson MW. A new quantitative scale for clinical scar assessment. Plast Reconstr Surg. 1998 Nov;102(6):1954-61. doi: 10.1097/00006534-199811000-00022.
- Homepage of Skin Research GroupLink provided by the sponsor.
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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.
Brian Berman, M.D., Ph.D. principal investigator
University of Miami Department of Dermatology and Cutaneous Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture and Clozex in people with Keloid, run by University of Miami 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 Mar 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Issues with application of Clozex intervention). Results are not available in the source record.
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?
Global appearance at Keloid site. (time frame: 12 (+/-2) days after excision of keloid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519493, which also lists 1 linked publication.
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 8 Mar 2019.