KeloidPhase 3NCT01158196
Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid
A Phase 3 study testing infra-red diode laser in people with Keloid and Surgical Scar, run by Ekkyo at 1 site in France.
Trial summary
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Keloid, Surgical Scar
- What is being tested?
- infra-red diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jun 2013
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Skin type from I to VI (Fitzpatrick classification scale)
- Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients
Who cannot join
- Malignant tumor pathology
- Infectious or viral skin disease
- Immunosuppressive pathology and/or immunosuppressive treatment,
- Long-term corticosteroid treatment
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.
- Conditions
- Keloid, Surgical Scar
- Being tested
- infra-red diode laser
- Keywords
- laser, keloid, scar
- Medical subject headings
- Keloid, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infra-red diode laserDevice
laser treatment of scar after keloid excision
laser treatment of surgery scar
| Study group | Role | What they receive |
|---|---|---|
| infra-red diode laser | Experimental | one session, one dose Receives: Device: infra-red diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
Measured: 10 days after surgery or excision
Secondary outcomes (4)
improvement of scarring for plastic surgery group
- Vancouver Scar Scale score
- Comparative scar assessment scale
- Observer assessment score (POSAS)
Measured: 12 months after surgery
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.
- Lesion size
- Vancouver scar scale
- Observer scar scale (POSAS)
Measured: 12 months after excision
quality of life assessment for keloid group
- VQ-dermato
- satisfaction questionnaire
Measured: 12 months after excision
Socio and medical economic evaluation for keloid group
Measured: 12 months after excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ekkyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guy Magalon, MD PhD, Principal investigator, plastic and reconstructive surgey department, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158196
- Sponsor's protocol ID
- E-200-M/keloid project
- Other IDs
- 2010-A00323-36
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 8 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
- ClinicalTrials.gov ID
- NCT01158196
- Acronym / sponsor ID
- E-200-M/keloid project
- Conditions
- Keloid, Surgical Scar
- Keywords
- laser, keloid, scar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- EkkyoIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 8 Jul 2010 (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.
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infra-red diode laser | Experimental | Device: infra-red diode laserone session, one dose |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Skin type from I to VI (Fitzpatrick classification scale)
- Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients
Key exclusion criteria (5 listed)
- Malignant tumor pathology
- Infectious or viral skin disease
- Immunosuppressive pathology and/or immunosuppressive treatment,
- Long-term corticosteroid treatment
- Pregnant woman
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 |
|---|---|---|
| infra-red diode laserlaser treatment of scar after keloid excision laser treatment of surgery scar | Device | infra-red diode laser |
Primary outcome
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
Time frame: 10 days after surgery or excision
4 secondary outcomes
improvement of scarring for plastic surgery group
Time frame: 12 months after surgery
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.
Time frame: 12 months after excision
quality of life assessment for keloid group
Time frame: 12 months after excision
Socio and medical economic evaluation for keloid group
Time frame: 12 months after excision
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2010.
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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.
Guy Magalon, MD PhD principal investigator
plastic and reconstructive surgey department, APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing infra-red diode laser in people with Keloid and Surgical Scar, run by Ekkyo at 1 site in France.
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 3 inclusion and 5 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 8 Jul 2010. 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 France. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Guy MAGALON, MD PhD (+33 (0)4 91 38 35 52, guy.magalon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion (time frame: 10 days after surgery or excision). 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 8 Jul 2010.