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NCT Number: NCT04165226

LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

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.

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Key information

Conditions

Striae; Albicantes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Striae Distensae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr El Ainy hospital

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Light Therapy

Device

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.

Fractional CO2

Device

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.

Combined fractional CO2 laser and low level light therapy

Device

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

Primary outcomes

  1. Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)

    Time frame: 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%).

  2. Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)

    Time frame: 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

  3. Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)

    Time frame: 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 outcomes

  1. Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1

    Time frame: 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%).

  2. Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1

    Time frame: 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%).

  3. Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1

    Time frame: 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

  4. Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)

    Time frame: 3 months

    Percentage of incidence of side effects (edema, pain, erythema, itching, start of peeling) in all patients

  5. 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2019
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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