Keloid Scar Following SurgeryEarly Phase 1NCT03876548
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
A Early Phase 1 study testing Cadexomer Iodine Gel in people with Keloid Scar Following Surgery, run by Next Science TM at 1 site in United States.
Trial summary
This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keloid Scar Following Surgery
- What is being tested?
- Cadexomer Iodine Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to 30 Jun 2019
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Each subject must meet the following criteria to be enrolled in this trial:
- Male or female 18 years or older
- Subject is healthy, as determined by the investigator based on a medical evaluation and history
- Subject has an established diagnosis of keloid scar formation
- Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
- Subject has one or more keloids eligible for scar revision
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- Subject has a keloid of appropriate size (1 to 2.5 cm in length, 4 to 5 mm in width, and 3 to 4 mm in height)
- Subject has no known allergies to study products
- Subject is willing and able to avoid total body water exposure from large bodies of water such as pools, lakes, oceans, etc. while using study medication
- Subject is willing and able to comply with the requirements of the protocol
- Subject is male or non-pregnant, non-lactating woman. Women must be one of the following:
- Naturally postmenopausal defined as ≥1 year without menses and:
- ≥ 55 years or
- < 55 years with follicle-stimulating hormone (FSH)≥40.0 IU/L, or
- Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or
- Women of childbearing potential willing to use an acceptable method(s) of birth control during the study, while using study medication including:
- Oral, topical, injectable, or implantable birth control medications,
- Placement of an intrauterine device with or without hormones,
- Barrier methods including condoms or occlusive cap with spermicidal foam or spermicidal jelly
- Vasectomized male partner who is the sole partner for this patient
- True abstinence that is in line with the preferred and usual lifestyle of the patient (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of the study or withdrawal are not acceptable methods of true abstinence).
- There are no protocol-specific birth control requirements for men with partners who are able to become pregnant
- Subject has understood and signed an Informed Consent Form
Who cannot join
- Each subject must meet the following criteria to be enrolled in this trial:
- Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
- Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
- Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
- Subject has a past history of coagulopathy
- Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
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- Subject is treated with anticoagulants or antiplatelet therapies
- Subject has a known allergy or sensitivity to any local anesthetic (such as lidocaine) or a local topical antiseptic that may be used (such as iodine)
- Subject has known allergic reaction to the study product
- Subject has a known history of shellfish allergy or sensitivity
- Subject has known history of Hashimoto's Thyroiditis, Graves' disease, a thyroid disorder, a non-toxic goiter
- Subject is taking Lithium, Sulphafurazoles or Sulphonylureas
- Subject is prone to Vasovagal syncope
- Subject is unable to provide signed and dated informed consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
About this study
Official title: Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study
This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.
Read the detailed description
The objective of this 6 month, interventional, open label prospective pilot study is to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision. Adults 18 years and older with an established diagnosis of keloid scar formation, scheduled to undergo keloid scar revision surgery, and who meet the protocol's inclusion and exclusion criteria are eligible for this study. There will be a minimum of 20 completed subjects with up to 30 enrolled. After keloid revision surgery, subjects will apply product every other day for one month. There will be a total of 5 study visits: Visit 0 (Revision Surgery Date and Start of Treatment); Visit 1 (1 Week Post-Revision); Visit 2 (4 Weeks Post-Revision); Visit 3 (12 Weeks Post Revision); and Visit 4 (24 Weeks Post-Revision and Study Exit). Imaging, Patient and Observer Scar Assessment Scale questionnaires, and Dermatological Life Quality Index Questions will be collected. It is hypothesized that there will be a measurable reduction in the amount (number, size) of keloid formation and/or recurrence at 4, 12, and 24 weeks post revision surgery time points. The change in subjects' quality of life as measured by the the Dermatology Quality of Life Index will also be assessed.
- Conditions
- Keloid Scar Following Surgery
- Being tested
- Cadexomer Iodine Gel
- Keywords
- keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadexomer Iodine GelDevice
Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cadexomer Iodine Gel | Experimental | Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage. Receives: Device: Cadexomer Iodine Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar measurement with Silhouette Camera Imaging
The keloid or keloid scar will measured using the Silhouette Camera Imaging System
Measured: 24 weeks
Patient and Observer Scar Assessment Scale (Subject facing)
Patient and Observer Scar Assessment to be completed by the subject with the physician.
Measured: 24 weeks
Patient and Observer Scar Assessment Scale (Non-Subject facing)
Patient and Observer Scar Assessment to be completed by the physician only.
Measured: 24 weeks
Response Rate calculation
Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)
Measured: 24 weeks
Secondary outcomes (1)
Dermatology Quality of Life Index
Dermatology Quality of Life Index Questionaire
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start7 Feb 2019
- Primary completionJun 2019 (estimated)
- Study completion30 Jun 2019
Why it stopped: Recruitment Challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid Scar Following SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jacksonville Center For Clinical Research
- Responsible party
- Sponsor
- Investigators
- Michael Bernhardt, MD, Principal investigator, Jacksonville Center For Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876548
- Sponsor's protocol ID
- CSP-008
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03876548
- Acronym / sponsor ID
- CSP-008
- Conditions
- Keloid Scar Following Surgery
- Keywords
- keloid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment Challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- Jacksonville Center For Clinical Research
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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 is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.
Detailed description
The objective of this 6 month, interventional, open label prospective pilot study is to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision. Adults 18 years and older with an established diagnosis of keloid scar formation, scheduled to undergo keloid scar revision surgery, and who meet the protocol's inclusion and exclusion criteria are eligible for this study. There will be a minimum of 20 completed subjects with up to 30 enrolled. After keloid revision surgery, subjects will apply product every other day for one month. There will be a total of 5 study visits: Visit 0 (Revision Surgery Date and Start of Treatment); Visit 1 (1 Week Post-Revision); Visit 2 (4 Weeks Post-Revision); Visit 3 (12 Weeks Post Revision); and Visit 4 (24 Weeks Post-Revision and Study Exit). Imaging, Patient and Observer Scar Assessment Scale questionnaires, and Dermatological Life Quality Index Questions will be collected. It is hypothesized that there will be a measurable reduction in the amount (number, size) of keloid formation and/or recurrence at 4, 12, and 24 weeks post revision surgery time points. The change in subjects' quality of life as measured by the the Dermatology Quality of Life Index will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Cadexomer Iodine Gel | Experimental | Device: Cadexomer Iodine GelPatients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female 18 years or older
- Subject is healthy, as determined by the investigator based on a medical evaluation and history
- Subject has an established diagnosis of keloid scar formation
- Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
- Subject has one or more keloids eligible for scar revision
Key exclusion criteria (14 listed)
- Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
- Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
- Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
- Subject has a past history of coagulopathy
- Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
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 |
|---|---|---|
| Cadexomer Iodine GelSubjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery. | Device | Cadexomer Iodine Gel |
Primary outcome
Scar measurement with Silhouette Camera Imaging
Time frame: 24 weeks
The keloid or keloid scar will measured using the Silhouette Camera Imaging System
Patient and Observer Scar Assessment Scale (Subject facing)
Time frame: 24 weeks
Patient and Observer Scar Assessment to be completed by the subject with the physician.
Patient and Observer Scar Assessment Scale (Non-Subject facing)
Time frame: 24 weeks
Patient and Observer Scar Assessment to be completed by the physician only.
Response Rate calculation
Time frame: 24 weeks
Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)
1 secondary outcome
Dermatology Quality of Life Index
Time frame: 24 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
Related trials for Keloid Scar Following Surgery
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Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact
Sternotomy Closure,Open Heart Surgery
RecruitingObservational study
Measuring the Volumes of Hypertrophic Scars and Keloids, Two Specific Kind of Scars, Over Different Points in Time in Patients Who Have Undergone Surgery and Evaluate 3D-cameras As a Possible Measuring and Documenting Tool Including Volumetry
Keloid Scar Following Surgery, Scars, Hypertrophic
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.
Michael Bernhardt, MD principal investigator
Jacksonville Center For Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cadexomer Iodine Gel in people with Keloid Scar Following Surgery, run by Next Science TM 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 23 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: withdrawn, as of the sponsor's last update on 26 Aug 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Scar measurement with Silhouette Camera Imaging (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 26 Aug 2019.