LLLT and Fractional CO2 Laser in the Treatment of Stria Alba

NCT04165226 | Completed

• 1 other identifier: MMikhail
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Striae; Albicantes

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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

Study Arms (3)

Low level light therapy (LLLT)

ACTIVE COMPARATOR

Low level light therapy using 808/915 nm infra red diode laser

Device: Low level light therapy

Fractional CO2

ACTIVE COMPARATOR

Fractional carbon dioxide laser 10600 nm

Device: Fractional CO2

Combined fractional CO2 and LLLT

ACTIVE COMPARATOR

Combined fractional CO2 laser and low level light therapy

Device: Combined fractional CO2 laser and low level light therapy

Interventions

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.

Low level light therapy (LLLT)

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.

Fractional CO2

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....

Combined fractional CO2 and LLLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, above the age of 18 years old, with stria alba.
• Both genders.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Ainy hospital

Cairo, Egypt

Location

Related Publications (19)

• 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.

  PMID: 22148016 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.

  PMID: 16176771 BACKGROUND

• Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

  PMID: 28748217 BACKGROUND

• Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci. 2014 Spring;5(2):58-62.

  PMID: 25653800 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.

  PMID: 16987267 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.

  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.

  PMID: 26923916 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.

  PMID: 28375972 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.

  PMID: 26580868 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.

  PMID: 26147455 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.

  PMID: 22374035 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.

  PMID: 23579949 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

  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.

  PMID: 9747352 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.

  PMID: 7955466 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.

  PMID: 1774350 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.

  PMID: 22796062 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.

  PMID: 28551068 BACKGROUND

• 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.

  PMID: 38890186 DERIVED

Related Links

• Low level light therapy device

MeSH Terms

Conditions

Striae Distensae

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Doaa Mahgoub, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

• Vanessa Hafez, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting resident

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: November 15, 2019
• Study Start: November 24, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

EG (1)