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LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

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ClinicalTrials.gov Identifier: NCT04165226
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Mikhail, 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.

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

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).


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Low level light therapy (LLLT)
Low level light therapy using 808/915 nm infra red diode laser
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.

Active Comparator: Fractional CO2
Fractional carbon dioxide laser 10600 nm
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.

  • 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.

Active Comparator: Combined fractional CO2 and LLLT
Combined fractional CO2 laser and low level light therapy
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....




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Egypt
Kasr El Ainy hospital
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Doaa Mahgoub, MD Cairo University
Principal Investigator: Vanessa Hafez, MD Cairo University

Additional Information:
Publications:
Weiss, R. A., McDaniel, D. H., Geronemus, R. G., Weiss, M. A., Beasley, K. L., Munavalli, G. M., & Bellew, S. G. (2005, September). Clinical experience with light-emitting diode (LED) photomodulation. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/16176771
Hamblin, M. R. (2017, May 19). Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/28748217/
Anders, J. J., Lanzafame, R. J., & Arany, P. R. (2015, April 01). Clinical features and risk factors for striae distensae in Korean adolescents. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390214/
K. Sawhney, Mossum & Hamblin, Michael. (2014). Low-level light therapy (LLLT) for cosmetics and dermatology. Progress in Biomedical Optics and Imaging - Proceedings of SPIE. 8932. 10.1117/12.2041330.
Elson, M. (1994). Topical tretinoin in the treatment of striae distensae and in the promotion of wound healing: A review. Journal of Dermatological Treatment, 5(3), 163-165. doi:10.3109/09546639409084563

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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina Mikhail, Kasr El Aini Hospital:
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
Additional relevant MeSH terms:
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Striae Distensae
Skin Manifestations
Signs and Symptoms