LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Striae; Albicantes

Intervention / Treatment
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* Device: Low level light therapy
* Device: Fractional CO2
* Device: Combined fractional CO2 laser and low level light therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low level light therapy (LLLT)<br>Low level light therapy using 808/915 nm infra red diode laser | Device: Low level light therapy<br>* 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.<br>|
| Active Comparator: Fractional CO2<br>Fractional carbon dioxide laser 10600 nm | Device: Fractional CO2<br>* 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.<br>|
| Active Comparator: Combined fractional CO2 and LLLT<br>Combined fractional CO2 laser and low level light therapy | Device: Combined fractional CO2 laser and low level light therapy<br>* Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study) | 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%). | 3 months | 
| Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study) | 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 | 3 months | 
| Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study) | 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%). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1 | 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%). | 1 month | 
| Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1 | 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%). | 1 month | 
| Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1 | 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 | 1 month | 
| Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling) | Percentage of incidence of side effects (edema, pain, erythema, itching, start of peeling) in all patients | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stria alba, Fractional CO2, Fractional carbon dioxide laser 00, Low level light therapy, Striae atrophicae, Infra red diode laser, 808 nm, 915 nm, 10600 nm