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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01158196

Enrollment

Registered

2010-07-08

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid, Surgical Scar

Keywords

laser, keloid, scar

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.

Interventions

DEVICEinfra-red diode laser

laser treatment of scar after keloid excision laser treatment of surgery scar

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Malignant tumor pathology * Infectious or viral skin disease * Immunosuppressive pathology and/or immunosuppressive treatment, * Long-term corticosteroid treatment * Pregnant woman

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
improvement of scarring for plastic surgery group	12 months after surgery	* Vancouver Scar Scale score * Comparative scar assessment scale * Observer assessment score (POSAS)
keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.	12 months after excision	* Lesion size * Vancouver scar scale * Observer scar scale (POSAS)
quality of life assessment for keloid group	12 months after excision	* VQ-dermato * satisfaction questionnaire
Socio and medical economic evaluation for keloid group	12 months after excision	—

Countries

France

Contacts

Primary ContactGuy MAGALON, MD PhD

guy.magalon@ap-hm.fr+33 (0)4 91 38 35 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026