Clinical trial NCT04165226: LLLT and Fractional CO2 Laser in the Treatment of Stria Alba
Official title: Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Striae; Albicantes
Keywords: 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
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
timeFrame: 3 months
measure: Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)
timeFrame: 3 months
measure: Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)
timeFrame: 3 months
Secondary outcomes:
measure: Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1
timeFrame: 1 month
measure: Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1
timeFrame: 1 month
measure: Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1
timeFrame: 1 month
measure: Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy hospital
Study officials:
affiliation: Cairo University
name: Doaa Mahgoub, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Vanessa Hafez, MD
role: PRINCIPAL_INVESTIGATOR
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