NCT04165226|Completed
LLLT and Fractional CO2 Laser in the Treatment of Stria Alba
Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study
Loading search results
Low Level Light Therapy and Fractional Carbon Dioxide Laser in the Treatment of Stria Alba: A Randomised Controlled Study
Sponsor study identifier
interventional
30
1 country
1
Study Start
November 24, 2018
Actual (reported)Primary Completion
September 17, 2019
Actual (reported)Study Completion
September 17, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 17, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2018
Actual (reported)December 20, 2018
Actual (reported)September 17, 2019
Actual (reported)September 17, 2019
Actual (reported)November 15, 2019
Actual (reported)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%).
Comparative effectiveness of the 3 intervention groups as assessed by physician global assessment at month 1
1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient global assessment at month 1
1 month
Comparative effectiveness of the 3 intervention groups as assessed by patient satisfaction score at month 1
1 month
Comparative tolerability of the 3 intervention groups as assessed by the incidence of side effects (edema, pain, erythema, itching, peeling)
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)
3 months
Low level light therapy using 808/915 nm infra red diode laser
Fractional carbon dioxide laser 10600 nm
Combined fractional CO2 laser and 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.
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.
Kasr El Ainy hospital
Cairo, Egypt
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.
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.
Doaa Mahgoub, MD
Cairo University
Vanessa Hafez, MD
Cairo University
30 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2018
First Posted
November 15, 2019
Study Start
November 24, 2018
Actual (reported)Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients
3 months
Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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/
Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
Primary Completion
September 17, 2019
Actual (reported)Study Completion
September 17, 2019
Actual (reported)Last Updated
June 17, 2020
Record last verified: 2020-06
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: