KeloidPhase 2KELOIDNCT02546076
Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars
A Phase 2 study testing Laser coagulation and Laser w/o coagulation in people with Keloid and Hypertrophic Scars, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid, Hypertrophic Scars
- What is being tested?
- Laser coagulation and Laser w/o coagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written informed consent
- Skin type I-IV
- Presence of long keloid/hypertrophic scar of at least 3 cm² and of uniform/symmetric type
- Willingness and ability to adhere study protocol
Who cannot join
- History of adverse events related to ablative fractional laser therapy
- Ablative resurfacing within the last 6 months on the scar
- Oral retinoid, any immunosuppressive treatments in the last 6 months
- Pregnancy, lactation
About this study
Official title: Within-subject Randomized Clinical Trial Comparing Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars
Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars.
The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.
The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent to laser with heat/coagulation in terms of scars volume reduction, while the secondary hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of post-operative erythema and hypopigmentation reduction.
Read the detailed description
Background
Skin injuries, such as lacerations or abrasions, due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Multiple modalities for improving the clinical appearance of scars have been attempted with varying success, including corticosteroids, dermabrasion, surgical revision, chemical peeling, silicone gel application, pressure therapy, and radiation. Lasers such as the carbon dioxide (CO2), erbium: yttrium-aluminum-garnet (Er:YAG), and pulsed dye (PDL) lasers have all been used with differing success in the treatment of scars. The goal of all these treatments is to soften depressions and stimulate neocollagenesis in order to fill in the residual defects.
Ablative lasers used for skin resurfacing, such as the CO2 and Er:YAG laser, can reduce various scars, but significant adverse effects limit their use, and patient downtime can be extensive. Owing to these potential risks, nonablative lasers have been developed as a safe alternative to ablative laser resurfacing, and have been reported to be effective and safe for scars. However outcomes have remained unsatisfactory and require several treatments to achieve satisfactory efficacy.
Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars, and some authors have suggested that treatment with fractional lasers for various scars, such as postoperative, atrophic, and acne scars, has been demonstrated to safely improve the appearance of the scars. However, there is a lack of studies comparing coagulation modality of such lasers.
Objective
The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.
Methods
This is a single center, investigator initiated, double blind, within-subject split-lesion design, equivalence randomized clinical study.
Consecutive patients, referring to Dermatology outpatient and fulfilling inclusion criteria, are included. Participants are then randomly assigned to get treatment with Er:YAG laser on half of scar section side by equally splitting the lesion area in two symmetric and uniform parts. One side will be treated with coagulation while the other one will be without. In case of multiple lesions per patient, only the largest and most uniform one is selected for the study purpose.
- Conditions
- Keloid, Hypertrophic Scars
- Being tested
- Laser coagulation, Laser w/o coagulation
- Keywords
- Keloid, Hypertrophic scars, Er-YAG Lasers
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser coagulationDevice
The treatment consists in performing Er:Yag laser with long-pulsed Erbium mode
Laser w/o coagulationDevice
The treatment consists in performing Er:Yag laser with true pulsed Erbium mode
| Study group | Role | What they receive |
|---|---|---|
| Laser coagulation | Active comparator | Er:YAG laser treatment with coagulation modality Receives: Device: Laser coagulation |
| Laser w/o coagulation | Active comparator | Er:YAG laser treatment without coagulation modality Receives: Device: Laser w/o coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any reduction from baseline of scars volume as assessed by image analysis
Measured: 24 weeks
Secondary outcomes (5)
Any reduction from baseline of scars volume as assessed by image analysis
Measured: 4, 8, 12, 16, 24 weeks
Any improvement of scars as assessed by physician according to an ordinal 6-points scale
Measured: 4, 8, 12, 16, 24 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
Measured: 16, 24 weeks
Erythema index as assessed by image analysis
Measured: 4, 8, 12, 16, 24 weeks
Hypopigmentation as assessed by image analysis
Measured: 4, 8, 12, 16, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Lack of patients
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.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurice Adatto, MD, Principal investigator, Dep. of Dermatology, Inselspital University Hospital, Bern (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546076
- Sponsor's protocol ID
- KELOID
- Acronym
- KELOID
- Status last verified
- Apr 2017
- First submitted
- 2 Sep 2015
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within-subject Randomized Clinical Trial Comparing Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT02546076
- Acronym / sponsor ID
- KELOID / KELOID
- Conditions
- Keloid, Hypertrophic Scars
- Keywords
- Keloid, Hypertrophic scars, Er-YAG Lasers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Sep 2015 (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.
Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars.
The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.
The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent to laser with heat/coagulation in terms of scars volume reduction, while the secondary hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of post-operative erythema and hypopigmentation reduction.
Detailed description
Background
Skin injuries, such as lacerations or abrasions, due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Multiple modalities for improving the clinical appearance of scars have been attempted with varying success, including corticosteroids, dermabrasion, surgical revision, chemical peeling, silicone gel application, pressure therapy, and radiation. Lasers such as the carbon dioxide (CO2), erbium: yttrium-aluminum-garnet (Er:YAG), and pulsed dye (PDL) lasers have all been used with differing success in the treatment of scars. The goal of all these treatments is to soften depressions and stimulate neocollagenesis in order to fill in the residual defects.
Ablative lasers used for skin resurfacing, such as the CO2 and Er:YAG laser, can reduce various scars, but significant adverse effects limit their use, and patient downtime can be extensive. Owing to these potential risks, nonablative lasers have been developed as a safe alternative to ablative laser resurfacing, and have been reported to be effective and safe for scars. However outcomes have remained unsatisfactory and require several treatments to achieve satisfactory efficacy.
Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars, and some authors have suggested that treatment with fractional lasers for various scars, such as postoperative, atrophic, and acne scars, has been demonstrated to safely improve the appearance of the scars. However, there is a lack of studies comparing coagulation modality of such lasers.
Objective
The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.
Methods
This is a single center, investigator initiated, double blind, within-subject split-lesion design, equivalence randomized clinical study.
Consecutive patients, referring to Dermatology outpatient and fulfilling inclusion criteria, are included. Participants are then randomly assigned to get treatment with Er:YAG laser on half of scar section side by equally splitting the lesion area in two symmetric and uniform parts. One side will be treated with coagulation while the other one will be without. In case of multiple lesions per patient, only the largest and most uniform one is selected for the study purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser coagulation | Active comparator | Device: Laser coagulationEr:YAG laser treatment with coagulation modality |
| Laser w/o coagulation | Active comparator | Device: Laser w/o coagulationEr:YAG laser treatment without coagulation modality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Given written informed consent
- Skin type I-IV
- Presence of long keloid/hypertrophic scar of at least 3 cm² and of uniform/symmetric type
- Willingness and ability to adhere study protocol
Key exclusion criteria (4 listed)
- History of adverse events related to ablative fractional laser therapy
- Ablative resurfacing within the last 6 months on the scar
- Oral retinoid, any immunosuppressive treatments in the last 6 months
- Pregnancy, lactation
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 |
|---|---|---|
| Laser coagulationThe treatment consists in performing Er:Yag laser with long-pulsed Erbium mode | Device | Laser coagulation |
| Laser w/o coagulationThe treatment consists in performing Er:Yag laser with true pulsed Erbium mode | Device | Laser w/o coagulation |
Primary outcome
Any reduction from baseline of scars volume as assessed by image analysis
Time frame: 24 weeks
5 secondary outcomes
Any reduction from baseline of scars volume as assessed by image analysis
Time frame: 4, 8, 12, 16, 24 weeks
Any improvement of scars as assessed by physician according to an ordinal 6-points scale
Time frame: 4, 8, 12, 16, 24 weeks
Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale
Time frame: 16, 24 weeks
Erythema index as assessed by image analysis
Time frame: 4, 8, 12, 16, 24 weeks
Hypopigmentation as assessed by image analysis
Time frame: 4, 8, 12, 16, 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 14 Apr 2017.
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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.
Maurice Adatto, MD principal investigator
Dep. of Dermatology, Inselspital University Hospital, Bern (Switzerland)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser coagulation and Laser w/o coagulation in people with Keloid and Hypertrophic Scars, run by Insel Gruppe AG, University Hospital Bern.
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 4 inclusion and 4 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Any reduction from baseline of scars volume as assessed by image analysis (time frame: 24 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 14 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.