LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04165226

Collaborator

(none)

Enrollment

Location

Arms

9.8

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Striae; Albicantes	Device: Low level light therapy Device: Fractional CO2 Device: Combined fractional CO2 laser and low level light therapy	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study

Actual Study Start Date :

Nov 24, 2018

Actual Primary Completion Date :

Sep 17, 2019

Actual Study Completion Date :

Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low level light therapy (LLLT) Low level light therapy using 808/915 nm infra red diode laser	Device: Low level light therapy Patients will be offered 8 sessions of photobiomodulation using HPL Pagani Diode 808/915nm LLLT 3.2W (Fimad Elettromedicali SRL®, Catanzaro, Italy) with the parameters adjusted individually according to the surface area to be treated. Optimum dose is 10 joules/cubic centimeters. The patients will take 2 to3 sessions / week.
Active Comparator: Fractional CO2 Fractional carbon dioxide laser 10600 nm	Device: Fractional CO2 Patients will be offered 2 sessions of fractional carbon dioxide laser on a 4 weeks interval. Topical anesthesia with pridocaine cream will be applied under occlusion for 30 - 60 minutes before the session. Please update to the proper apparatus and parameters DEXA SmartXide DOT Fractional CO2 laser system 10600 nm (DEKA®, Florence, Italy) will be used with the following parameters adjusted individually to patients': power of 15-20 W, dwell time of 500-800 μs, spacing of 200-500 μm, and stack 2.
Active Comparator: Combined fractional CO2 and LLLT Combined fractional CO2 laser and low level light therapy	Device: Combined fractional CO2 laser and low level light therapy Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....

Arm

Intervention/Treatment

Active Comparator: Low level light therapy (LLLT)

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

Device: Low level light therapy

Patients will be offered 8 sessions of photobiomodulation using HPL Pagani Diode 808/915nm LLLT 3.2W (Fimad Elettromedicali SRL®, Catanzaro, Italy) with the parameters adjusted individually according to the surface area to be treated. Optimum dose is 10 joules/cubic centimeters. The patients will take 2 to3 sessions / week.

Active Comparator: Fractional CO2

Fractional carbon dioxide laser 10600 nm

Device: Fractional CO2

Patients will be offered 2 sessions of fractional carbon dioxide laser on a 4 weeks interval. Topical anesthesia with pridocaine cream will be applied under occlusion for 30 - 60 minutes before the session. Please update to the proper apparatus and parameters DEXA SmartXide DOT Fractional CO2 laser system 10600 nm (DEKA®, Florence, Italy) will be used with the following parameters adjusted individually to patients': power of 15-20 W, dwell time of 500-800 μs, spacing of 200-500 μm, and stack 2.

Active Comparator: Combined fractional CO2 and LLLT

Combined fractional CO2 laser and low level light therapy

Device: Combined fractional CO2 laser and low level light therapy

Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....

Outcome Measures

Primary Outcome Measures

Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study) [3 months]
Patients will be assessed before and after treatment by one unblinded and one 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%).
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study) [3 months]
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
Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study) [3 months]
Patients will be assessed before and after treatment by one unblinded and one 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%).

Secondary Outcome Measures

Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1 [1 month]
Patients will be assessed before and after treatment by one unblinded and one 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%).
Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1 [1 month]
Patients will be assessed before and after treatment by one unblinded and one 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%).
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1 [1 month]
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
Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling) [3 months]
Percentage of incidence of side effects (edema, pain, erythema, itching, start of peeling) in all patients
Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling) [3 months]
Comparative tolerability of the fractional CO2 versus combined fractional and LLLT as regards duration of side effects in days after each laser session (edema, pain, erythema, itching, peeling)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.