Efficacy of Short Pulsed 1064 nm Nd-YAG Laser Versus 10600 nm Fractional CO2 Laser in Treatment of Striae Alba

NCT04092881 | Unknown FDA Device

• 1 other identifier: Short Nd-YAG vs Fr.CO2 for SA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Striae alba is a clinical variant of striae distensae characterized by focal dermal collagen loss and thinning of elastic fibers. Carbon dioxide (CO2) laser is an ablative laser modality that ablates defective collagen and stimulates new collagen formation. Neodymium-Doped Yttrium Aluminum Garnet (Nd-YAG) laser is a non ablative modality that results in stimulation of collagen formation through dermal heating. High frequency skin ultrasound is a rapid and non-invasive tool for measurement f skin thickness and can be used for this purpose.

Conditions

Striae Distensae; Striae; Albicantes; Striae Alba; Nd-YAG Laser; Fractional CO2 Laser; High Frequency Skin Ultrasound; Short Pulsed Nd-YAG; Carbon Dioxide Laser; Neodymium-Doped Yttrium Aluminum Garnet Laser

Keywords

Striae Distensae; Striae; Albicantes; Striae Alba; Nd-YAG Laser; Fractional CO2 Laser; High Frequency Skin Ultrasound; Short Pulsed Nd-YAG; Carbon Dioxide Laser; Neodymium-Doped Yttrium Aluminum Garnet Laser

Outcome Measures

Primary Outcomes (1)

• Assessment of the efficacy and therapeutic superiority of both laser machines by measuring both clinical improvement using modified Davey's score and visually by measuring different skin thickness planes using high frequency skin ultrasound

  Assessment of the efficacy and therapeutic superiority of either 1064 nm Nd-YAG laser or 10600 nm fractional CO2 laser as treatment modalities for patients with striae alba guided by investigated dermal changes obtained by high frequency skin ultrasound machine, namely: dermal thickness, sub epidermal low echogenicity band thickness and epidermal thickness, both before and after treatment with both laser machines. Statistical analysis of outcome data shall be carried out to determine significance of efficacy of one laser modality over the other.

  20 - 24 months

Secondary Outcomes (1)

• Treating and improving lesions of striae alba for 25 patients included in the sample size using both laser machines, one on each side in a rate of one session per month for four months duration

  20 - 24 months

Study Arms (2)

Short pulsed Nd-YAG laser treatment side

ACTIVE COMPARATOR

Neodymium-Doped Yttrium Aluminum Garnet (Nd-YAG) (Fotona XP®) laser is a successful therapeutic modality and is characterized by its safe profile compared to other lasers. Short pulsed Nd-YAG laser (Fotona XP® Accelera mode) results in a non-ablative dermal heating with intact overlying epidermis which has shown a potential for dermal collagen remodeling in histological sections.

Device: Laser

Fractional ablative CO2 laser treatment side

ACTIVE COMPARATOR

Carbon dioxide (CO2) (Deka SmartXide DOT®) laser is one of the well-tolerated therapeutic modalities used for treatment of different skin disorders including striae alba. CO2 laser targets mainly water content in both epidermis and dermis causing vaporization of target cells. Fractional ablative CO2 laser creates columns of focal dermo-epidermal tissue loss known as (microablative columns) with thermal damage, hemostatic effect and incomplete coagulation of tissues. This ablation of dermal tissues (including collagen and elastin) has the potential for stimulation of new tissue formation in striae distensae.

Device: Laser

Interventions

Laser DEVICE

Application of four laser sessions one month apart using short pulsed mode of 1064 nm Nd-YAG laser (Fotona XP® - Accelera mode) using parameters (fluence 20-40 J/Cm2, pulse duration= 0.25 ms and spot size 3-5 mm) for one side.

Also known as: Short pulsed Nd-YAG laser (Fotona XP® device - Accelera mode)

Short pulsed Nd-YAG laser treatment side

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with striae alba.
• Ages between 14 years - 50 years.
• Both sexes.
• Skin types I-IV
• Bilateral striae.

You may not qualify if:

• Patients with striae rubra, striae nigra, striae caerulea or striae atrophicans.
• History of diseases associated with SD (cushing disease or Marfan syndrome).
• History of drugs associated with development of SD (topical or systemic glucocorticoids, Indinavir or protease inhibitors).
• History of conditions with abnormal dermal connective tissue structure (Ehler-Danlos syndrome, cutis laxa, pseudoxanthoma elasticum, elastolysis, elastomas, hyaline fibromatosis, keloidal tendencies, skin atrophy, poikiloderma or anetoderma).
• Current state of pregnancy in female patients.
• Relative contraindications to laser therapy (photosensitive dermatoses or burns).
• History of any therapeutic procedure for striae in the past 6 months before enrollment in the study.
• History of conditions associated with dermal edema or lymphedema.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 35855, Egypt

RECRUITING

Related Publications (16)

• Mikes BA, Oakley AM, Patel BC. Striae Distensae. 2025 May 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK436005/

  PMID: 28613776 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

• Omi T, Numano K. The Role of the CO2 Laser and Fractional CO2 Laser in Dermatology. Laser Ther. 2014 Mar 27;23(1):49-60. doi: 10.5978/islsm.14-RE-01.

  PMID: 24771971 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

• Lee SE, Kim JH, Lee SJ, Lee JE, Kang JM, Kim YK, Bang D, Cho SB. Treatment of striae distensae using an ablative 10,600-nm carbon dioxide fractional laser: a retrospective review of 27 participants. Dermatol Surg. 2010 Nov;36(11):1683-90. doi: 10.1111/j.1524-4725.2010.01719.x. Epub 2010 Sep 14.

  PMID: 20840494 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.

  PMID: 22148016 BACKGROUND

• Ryu HW, Kim SA, Jung HR, Ryoo YW, Lee KS, Cho JW. Clinical improvement of striae distensae in Korean patients using a combination of fractionated microneedle radiofrequency and fractional carbon dioxide laser. Dermatol Surg. 2013 Oct;39(10):1452-8. doi: 10.1111/dsu.12268. Epub 2013 Jul 29.

  PMID: 23895146 BACKGROUND

• Fatemi Naeini F, Behfar S, Abtahi-Naeini B, Keyvan S, Pourazizi M. Promising Option for Treatment of Striae Alba: Fractionated Microneedle Radiofrequency in Combination with Fractional Carbon Dioxide Laser. Dermatol Res Pract. 2016;2016:2896345. doi: 10.1155/2016/2896345. Epub 2016 Mar 16.

  PMID: 27069471 BACKGROUND

• Naein FF, Soghrati M. Fractional CO2 laser as an effective modality in treatment of striae alba in skin types III and IV. J Res Med Sci. 2012 Oct;17(10):928-33.

  PMID: 23825991 BACKGROUND

• Gianfaldoni S, Tchernev G, Wollina U, Fioranelli M, Roccia MG, Gianfaldoni R, Lotti T. An Overview of Laser in Dermatology: The Past, the Present and ... the Future (?). Open Access Maced J Med Sci. 2017 Jul 23;5(4):526-530. doi: 10.3889/oamjms.2017.130. eCollection 2017 Jul 25.

  PMID: 28785350 BACKGROUND

• Gungor S, Sayilgan T, Gokdemir G, Ozcan D. Evaluation of an ablative and non-ablative laser procedure in the treatment of striae distensae. Indian J Dermatol Venereol Leprol. 2014 Sep-Oct;80(5):409-12. doi: 10.4103/0378-6323.140296.

  PMID: 25201840 BACKGROUND

• Elsaie ML, Hussein MS, Tawfik AA, Emam HM, Badawi MA, Fawzy MM, Shokeir HA. Comparison of the effectiveness of two fluences using long-pulsed Nd:YAG laser in the treatment of striae distensae. Histological and morphometric evaluation. Lasers Med Sci. 2016 Dec;31(9):1845-1853. doi: 10.1007/s10103-016-2060-2. Epub 2016 Sep 5.

  PMID: 27595152 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

• Bleve M, Capra P, Pavanetto F, Perugini P. Ultrasound and 3D Skin Imaging: Methods to Evaluate Efficacy of Striae Distensae Treatment. Dermatol Res Pract. 2012;2012:673706. doi: 10.1155/2012/673706. Epub 2011 Nov 22.

  PMID: 22203840 BACKGROUND

• Davey CM. Factors associated with the occurrence of striae gravidarum. J Obstet Gynaecol Br Commonw. 1972 Dec;79(12):1113-4. doi: 10.1111/j.1471-0528.1972.tb11896.x. No abstract available.

  PMID: 4646568 BACKGROUND

• Al-Himdani S, Ud-Din S, Gilmore S, Bayat A. Striae distensae: a comprehensive review and evidence-based evaluation of prophylaxis and treatment. Br J Dermatol. 2014 Mar;170(3):527-47. doi: 10.1111/bjd.12681.

  PMID: 24125059 BACKGROUND

MeSH Terms

Conditions

Striae Distensae

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Heba Abd El-Kader, MD

  Lecturer of Dermatology, Cairo University

  STUDY CHAIR

• Manal A. Bosseila, MD

  Professor of Dermatology, Cairo University

  PRINCIPAL INVESTIGATOR

• Khaled El Kaffas, MD

  Associate Professor of Investigative Radiology, Department of Radiology, Cairo University

  STUDY CHAIR

• Omar M. El-Ghanam, MSc

  Dermatology Specialist

  STUDY DIRECTOR

Central Study Contacts

Omar M. El-Ghanam, MSc

CONTACT

+201002015057; morasystem@hotmail.com

Manal A. Bosseila, MD

CONTACT

+201002412964; manal.bosseila@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Comparable sides of striae are randomly allocated to one of the treatment modalities in a randomized table technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of dermatology - cairo university

Model Details: * Written informed consent is to be obtained from each participant. * Detailed history taking including onset, course, duration of the disease and received medications. * Serial digital photography before and after each session and three months after sessions. * Clinical assessment to determine the severity of SD using modified Davey's visual score. * Comparable sides of striae are randomly allocated to one of the treatment modalities in a randomized table technique. * Application of four laser sessions one month apart using short pulsed mode of 1064 nm Nd-YAG laser (Fotona XP® Accelera mode) for one side and 10600 nm ablative fractional CO2 laser (Deka SmartXide DOT®) on the other. Sessions are separated by one month interval plus three months for clinical follow up. * Assessment using high frequency skin ultrasound before session, before 4th session and 3 months after last session.

Study Record Dates

• First Submitted: August 3, 2019
• First Posted: September 17, 2019
• Study Start: February 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)