LLLT and Fractional CO2 Laser in the Treatment of Stria Alba
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| ClinicalTrials.gov Identifier: NCT04165226 |
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Recruitment Status :
Enrolling by invitation
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
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| 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 | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | November 24, 2018 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | December 24, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Low level light therapy (LLLT)
Low level light therapy using 808/915 nm infra red diode laser
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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. |
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Active Comparator: Fractional CO2
Fractional carbon dioxide laser 10600 nm
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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.
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Active Comparator: Combined fractional CO2 and LLLT
Combined fractional CO2 laser and low level light therapy
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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.... |
- Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study) [ Time Frame: 3 months ]Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study)
- Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study) [ Time Frame: 3 months ]Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study)
- Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study) [ Time Frame: 3 months ]Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study)
- Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1 [ Time Frame: 1 month ]Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1
- Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1 [ Time Frame: 1 month ]Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1
- Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1 [ Time Frame: 1 month ]Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1
- Comparative tolerability of the 3 intervention groups as assessed incidence of side effects (edema, pain, erythema, itching, peeling) [ Time Frame: 3 months ]Comparative tolerability of the 3 intervention groups as assessed incidence of side effects (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) [ 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165226
| Egypt | |
| Kasr El Ainy hospital | |
| Cairo, Egypt | |
| Principal Investigator: | Doaa Mahgoub, MD | Cairo University | |
| Principal Investigator: | Vanessa Hafez, MD | Cairo University |
Additional Information:
Publications:
| Responsible Party: | Marina Mikhail, Visiting resident, Kasr El Aini Hospital |
| ClinicalTrials.gov Identifier: | NCT04165226 History of Changes |
| Other Study ID Numbers: |
MMikhail |
| First Posted: | November 15, 2019 Key Record Dates |
| Last Update Posted: | November 15, 2019 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | IPD that underlie results in a publication, as well as protocol and statistical plan analysis, are to be published starting 6 months after the publication of summary data. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Starting 6 moths after publication of summary data |
| Access Criteria: | Data will be available for 6 months and allowed access only after approval of access requests by the principal investigators. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Striae Distensae Skin Manifestations Signs and Symptoms |