LLLT and Fractional CO2 Laser in the Treatment of Stria Alba
- Conditions
- Striae; Albicantes
- Interventions
- Device: Low level light therapyDevice: Fractional CO2Device: Combined fractional CO2 laser and low level light therapy
- Registration Number
- NCT04165226
- Lead Sponsor
- Kasr El Aini Hospital
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Subjects, above the age of 18 years old, with stria alba.
- Both genders.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low level light therapy (LLLT) Low level light therapy Low level light therapy using 808/915 nm infra red diode laser Fractional CO2 Fractional CO2 Fractional carbon dioxide laser 10600 nm Combined fractional CO2 and LLLT Combined fractional CO2 laser and low level light therapy Combined fractional CO2 laser and low level light therapy
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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)
Trial Locations
- Locations (1)
Kasr El Ainy hospital
🇪🇬Cairo, Egypt