LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

Kasr El Aini Hospital

Status: Completed

Conditions: Striae; Albicantes

Treatments: Device: Combined fractional CO2 laser and low level light therapy; Device: Low level light therapy; Device: Fractional CO2

Study type: Interventional

Funder types: Other

Identifiers

NCT04165226

MMikhail

Details and patient eligibility

About

Stria alba (aka white or atrophic stretch marks) is a very common dermatologic condition that causes major psychological distress to those afflicted. We study the effect of low level light therapy using infra red diode 808/915 nm laser in comparison to fractional CO2 alone and combined both therapies.

Full description

All patients will be subjected to the following:

• Written informed consent.
• Detailed history and clinical evaluation.

The treated areas will be photographed (in standardized settings of light and position) and measured in order to allow comparison and assessment of striae improvement following treatment.

Patients will be allocated according to randomization into one of 3 arms:

Arm A will be treated by fractional CO2 laser. Arm B will be treated by low level light therapy (LLLT). Arm C will be treated with a combination of fractional CO2 laser and LLLT.

Digital photographs will be taken for each patient, at the baseline and 1 and 3 months after last session and the width of the widest striae in each patient will be measured at the same time. Patients will be assessed before and after treatment by one unblinded and 2 blinded investigators to measure the clinical improvement on a 4-point scale by comparing the photographs. The criteria for evaluation using a quartile grading scale will be as follows; 0=no improvement, 1=mild improvement (<25%), 2=moderate improvement (26% - 50%), 3=good improvement (51% -75%), 4=excellent improvement (>76%).

In addition, a patient satisfaction score will be rated using the following scale; 0=not satisfied, 1=slightly satisfied, 2= satisfied, 3=very satisfied, 4=extremely satisfied as well as patients' satisfaction questionnaire (Yang and Lee; 2011).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects, above the age of 18 years old, with stria alba.
• Both genders.

Exclusion criteria

• Pregnant or lactating females.
• Subjects who were treated with any interventional procedure (lasers, radiofrequency, dermabrasion, microdermabrasion, or chemical peeling) within 6 months prior to the study.
• Subjects who applied topical corticosteroids, retinoid, vitamin C, or vitamin E within 3 months prior to the study.
• Subjects who orally took retinoids or corticosteroids within 3 months.
• Subjects who had a history of hypertrophic scar, keloid or immunosuppression or cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Low level light therapy (LLLT)

Active Comparator group

Description:

Low level light therapy using 808/915 nm infra red diode laser

Treatment:

Device: Low level light therapy

Fractional CO2

Active Comparator group

Description:

Fractional carbon dioxide laser 10600 nm

Treatment:

Device: Fractional CO2

Combined fractional CO2 and LLLT

Active Comparator group

Description:

Combined fractional CO2 laser and low level light therapy

Treatment:

Device: Combined fractional CO2 laser and low level light therapy