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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.
All patients will be subjected to the following:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low level light therapy (LLLT) | Active Comparator | Low level light therapy using 808/915 nm infra red diode laser |
|
| Fractional CO2 | Active Comparator | Fractional carbon dioxide laser 10600 nm |
|
| Combined fractional CO2 and LLLT | Active Comparator | Combined fractional CO2 laser and low level light therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 3 (End of study) | 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 months |
| Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 3 (End of study) | 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 months |
| Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 3 (End of study) | 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 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1 | 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%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doaa Mahgoub, MD | Cairo University | Principal Investigator |
| Vanessa Hafez, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Ainy hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22148016 | Background | Yang YJ, Lee GY. Treatment of Striae Distensae with Nonablative Fractional Laser versus Ablative CO(2) Fractional Laser: A Randomized Controlled Trial. Ann Dermatol. 2011 Nov;23(4):481-9. doi: 10.5021/ad.2011.23.4.481. Epub 2011 Nov 3. | |
| 16176771 | Background | Weiss RA, McDaniel DH, Geronemus RG, Weiss MA, Beasley KL, Munavalli GM, Bellew SG. Clinical experience with light-emitting diode (LED) photomodulation. Dermatol Surg. 2005 Sep;31(9 Pt 2):1199-205. doi: 10.1111/j.1524-4725.2005.31926. |
| Label | URL |
|---|---|
| Low level light therapy device | View source |
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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.
Starting 6 moths after publication of summary data
Data will be available for 6 months and allowed access only after approval of access requests by the principal investigators.
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| 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.
|
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| 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.... |
|
| 1 month |
| Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1 | 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%). | 1 month |
| Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1 | 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 | 1 month |
| Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling) | Percentage of incidence of side effects (edema, pain, erythema, itching, start of peeling) in all patients | 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) | 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 |
| Background | 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/ |
| 25653800 | Background | Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62. |
| Background | 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/ |
| Background | 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. |
| 26923916 | Background | Aldahan AS, Shah VV, Mlacker S, Samarkandy S, Alsaidan M, Nouri K. Laser and Light Treatments for Striae Distensae: A Comprehensive Review of the Literature. Am J Clin Dermatol. 2016 Jun;17(3):239-56. doi: 10.1007/s40257-016-0182-8. |
| 28375972 | Background | Ross NA, Ho D, Fisher J, Mamalis A, Heilman E, Saedi N, Jagdeo J. Striae Distensae: Preventative and Therapeutic Modalities to Improve Aesthetic Appearance. Dermatol Surg. 2017 May;43(5):635-648. doi: 10.1097/DSS.0000000000001079. |
| 26580868 | Background | Mishra V, Miller L, Alsaad SM, Ross EV. The Use of a Fractional Ablative Micro-Plasma Radiofrequency Device in Treatment of Striae. J Drugs Dermatol. 2015 Nov;14(11):1205-8. |
| 26147455 | Background | Ibrahim ZA, El-Tatawy RA, El-Samongy MA, Ali DA. Comparison between the efficacy and safety of platelet-rich plasma vs. microdermabrasion in the treatment of striae distensae: clinical and histopathological study. J Cosmet Dermatol. 2015 Dec;14(4):336-46. doi: 10.1111/jocd.12160. Epub 2015 Jul 6. |
| 22374035 | Background | Mazzarello V, Farace F, Ena P, Fenu G, Mulas P, Piu L, Rubino C. A superficial texture analysis of 70% glycolic acid topical therapy and striae distensae. Plast Reconstr Surg. 2012 Mar;129(3):589e-590e. doi: 10.1097/PRS.0b013e3182419c40. No abstract available. |
| 23579949 | Background | Ud-Din S, McAnelly SL, Bowring A, Whiteside S, Morris J, Chaudhry I, Bayat A. A double-blind controlled clinical trial assessing the effect of topical gels on striae distensae (stretch marks): a non-invasive imaging, morphological and immunohistochemical study. Arch Dermatol Res. 2013 Sep;305(7):603-17. doi: 10.1007/s00403-013-1336-7. Epub 2013 Apr 12. |
| Background | 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 |
| 9747352 | Background | Watson RE, Parry EJ, Humphries JD, Jones CJ, Polson DW, Kielty CM, Griffiths CE. Fibrillin microfibrils are reduced in skin exhibiting striae distensae. Br J Dermatol. 1998 Jun;138(6):931-7. doi: 10.1046/j.1365-2133.1998.02257.x. |
| 7955466 | Background | Lee KS, Rho YJ, Jang SI, Suh MH, Song JY. Decreased expression of collagen and fibronectin genes in striae distensae tissue. Clin Exp Dermatol. 1994 Jul;19(4):285-8. doi: 10.1111/j.1365-2230.1994.tb01196.x. |
| 1774350 | Background | Sheu HM, Yu HS, Chang CH. Mast cell degranulation and elastolysis in the early stage of striae distensae. J Cutan Pathol. 1991 Dec;18(6):410-6. doi: 10.1111/j.1600-0560.1991.tb01376.x. |
| 22796062 | Background | Gilmore SJ, Vaughan BL Jr, Madzvamuse A, Maini PK. A mechanochemical model of striae distensae. Math Biosci. 2012 Dec;240(2):141-7. doi: 10.1016/j.mbs.2012.06.007. Epub 2012 Jul 14. |
| 28551068 | Background | Hague A, Bayat A. Therapeutic targets in the management of striae distensae: A systematic review. J Am Acad Dermatol. 2017 Sep;77(3):559-568.e18. doi: 10.1016/j.jaad.2017.02.048. Epub 2017 May 24. |
| 16987267 | Background | Cho S, Park ES, Lee DH, Li K, Chung JH. Clinical features and risk factors for striae distensae in Korean adolescents. J Eur Acad Dermatol Venereol. 2006 Oct;20(9):1108-13. doi: 10.1111/j.1468-3083.2006.01747.x. |
| 38890186 | Derived | Hafez V, Mahgoub D, Satour EMA, Mikhail MMS, El-Kalioby M. Photobiomodulation versus fractional carbon dioxide laser for stria alba in phototype III-IV: a randomized controlled study. Lasers Med Sci. 2024 Jun 19;39(1):159. doi: 10.1007/s10103-024-04107-x. |