Scar Improvement by LaserNCT03253484
Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
A study testing NAFL-treatment in people with Scar Improvement by Laser, run by Bispebjerg Hospital.
Trial summary
The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar Improvement by Laser
- What is being tested?
- NAFL-treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2017to 31 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions.
- The length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body
- Minimum 18 years old
- Presenting full medical record report at study initiation
- Fitzpatrick skin type I-III
- Non-smokers
- Written informed consent obtained from subject
- Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation
Who cannot join
- o History of or presenting with a keloid scar
- A subject with a systemic disease not yet stabilized
- If the patient is pregnant
- Visible recent sun exposure in test area
- Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results
- Unable to follow the outlined study protocol
About this study
The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.
Read the detailed description
This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.
- Conditions
- Scar Improvement by Laser
- Being tested
- NAFL-treatment
- Keywords
- scar NAFL laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAFL-treatmentRadiation
non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
| Study group | Role | What they receive |
|---|---|---|
| NAFL-treated wounds | Experimental | NAFL treated wounds Receives: Radiation: NAFL-treatment |
| Control | No intervention | untreated control wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clincial evaluation on Patient observer scar assessement scale (POSAS)
validated scar scale
Measured: 3 months followup
Secondary outcomes (5)
Photoevaluation on visual analogue scale
3 independent dermatologists will evaluate on VAS
Measured: 3 months follow-up
Reflectance measurement
measurement of erythema and pigment
Measured: 3 months followup
Clinical evaluation on Vancouver Scar Scale
validated scar scale
Measured: 3 months followup
Clincial evaluation on Patient observer scar assessement scale (POSAS)
validated scar scale
Measured: 1month follow-up
Clinical evaluation on Vancouver Scar Scale
validated scar scale
Measured: 1month follow-up and
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start18 Aug 2017 (estimated)
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Jan 2018 (estimated)
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 Scar Improvement by LaserStudies 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
- Model description
- split scar study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrine Elisabeth Karmisholt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253484
- Sponsor's protocol ID
- H-17012492
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karmisholt KE, Banzhaf CA, Glud M, Yeung K, Paasch U, Nast A, Haedersdal M. Laser treatments in early wound healing improve scar appearance: a randomized split-wound trial with nonablative fractional laser exposures vs. untreated controls. Br J Dermatol. 2018 Dec;179(6):1307-1314. doi: 10.1111/bjd.17076. Epub 2018 Sep 30.
PubMed 30101519
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
- ClinicalTrials.gov ID
- NCT03253484
- Acronym / sponsor ID
- H-17012492
- Conditions
- Scar Improvement by Laser
- Keywords
- scar NAFL laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 18 Aug 2017 (estimated)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 18 Aug 2017 (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.
The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.
Detailed description
This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split scar study
| Arm | Type | Receives |
|---|---|---|
| NAFL-treated wounds | Experimental | Radiation: NAFL-treatmentNAFL treated wounds |
| Control | No intervention | –untreated control wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions.
Key exclusion criteria (7 listed)
- o History of or presenting with a keloid scar
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 |
|---|---|---|
| NAFL-treatmentnon ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation | Radiation | NAFL-treated wounds |
Primary outcome
Clincial evaluation on Patient observer scar assessement scale (POSAS)
Time frame: 3 months followup
validated scar scale
5 secondary outcomes
Photoevaluation on visual analogue scale
Time frame: 3 months follow-up
Reflectance measurement
Time frame: 3 months followup
Clinical evaluation on Vancouver Scar Scale
Time frame: 3 months followup
Clincial evaluation on Patient observer scar assessement scale (POSAS)
Time frame: 1month follow-up
Clinical evaluation on Vancouver Scar Scale
Time frame: 1month follow-up and
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Derived from this study: PubMed 30101519Karmisholt KE, Banzhaf CA, Glud M, Yeung K, Paasch U, Nast A, Haedersdal M. Laser treatments in early wound healing improve scar appearance: a randomized split-wound trial with nonablative fractional laser exposures vs. untreated controls. Br J Dermatol. 2018 Dec;179(6):1307-1314. doi: 10.1111/bjd.17076. Epub 2018 Sep 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing NAFL-treatment in people with Scar Improvement by Laser, run by Bispebjerg Hospital.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Aug 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.
Are results available for this study?
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?
Clincial evaluation on Patient observer scar assessement scale (POSAS) (time frame: 3 months followup). 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 NCT03253484, 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 18 Aug 2017.