Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03240718

Enrollment

Registered

2017-08-07

Start date

2015-02-28

Completion date

2016-12-31

Last updated

2017-08-17

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

Conditions

Burns

Brief summary

This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.

Detailed description

Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.

Interventions

PROCEDURELaser treatment

CORE fractional CO2 laser treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Fitzpatrick skin type \<IV (37), * Have sustained a thermal burn injury, * Have at least 2 independent sites that show clinical evidence of HSc, * Are 2 months or more post-injury.

Exclusion criteria

* Subjects with skin phototypes IV or higher, * With history of keloidal scarring, * Who have coagulation disorder, * Are taking immunosuppressive medications, * If the mechanism of injury is an electrical, chemical, or cold injury, * Any underlying active skin disease, * Have taken oral Isotreinoin within the last 6 months, * Photosensitivity or have taken photosensitizing medications, * Pregnancy, * Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment

Design outcomes

Primary

Measure	Time frame	Description
Skin Characteristics changes	baseline, 12 weeks and 24 weeks	Erythema, elasticity and thickness measures

Secondary

Measure	Time frame	Description
Satisfaction Questionnaire	baseline, 24 weeks	Questionnaire

Outcome results

None listed

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