Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid
Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
2 other identifiers
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 8, 2010
July 1, 2010
2.8 years
July 6, 2010
July 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
10 days after surgery or excision
Secondary Outcomes (4)
improvement of scarring for plastic surgery group
12 months after surgery
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.
12 months after excision
quality of life assessment for keloid group
12 months after excision
Socio and medical economic evaluation for keloid group
12 months after excision
Study Arms (1)
infra-red diode laser
EXPERIMENTALone session, one dose
Interventions
laser treatment of scar after keloid excision laser treatment of surgery scar
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Malignant tumor pathology
- Infectious or viral skin disease
- Immunosuppressive pathology and/or immunosuppressive treatment,
- Long-term corticosteroid treatment
- Pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ekkyolead
Study Sites (1)
Magalon
Marseille, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy Magalon, MD PhD
plastic and reconstructive surgey department, APHM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 8, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
July 8, 2010
Record last verified: 2010-07