Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser

NCT03390439 | Completed

• 1 other identifier: 47639415.1.0000.5327
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

As atrophic striae are common dermatological conditions. Various therapeutic modalities have been employed in the treatment of striae distensae, mainly in striae rubra. There are few studies that include the treatment of striae alba. The non-ablative fractionated laser and, more recently, microneedling are two distinct treatments, but they are widely used in dermatologist practice. The present randomized clinical trial is aimed at evaluating and evaluating the response of microneedle and fractional non-ablative laser Nd-yap 1340 in the treatment of abdominal striae alba.

Conditions

Striae Distensae

Keywords

Striae alba; Microneedling; Fractional nonablative laser; dermaroller; Nd-yap 1340nm laser; Percutaneous Collagen Induction Therapy

Outcome Measures

Primary Outcomes (1)

• Clinical response in abdominal alba striae after the therapies

  Clinical response to microneedle treatment and nonablative fractional laser treatment without abdominal alba striae (GAIS scale). The GAIS scale is a non-numerical scale divided into 5 categories of clinical response: very much improved, much improved, improved, no changed and worse.

  6 months

Secondary Outcomes (11)

• Clinical response to microneedle treatment and nonablative fractional laser treatment

  4 months

• Histopatological response in abdominal striae alba after the therapies

  4 months

• Histopatological response in abdominal striae alba after the therapies

  6 months

• The tolerability and incidence of adverse effects during the therapies

  1 month

• The tolerability and incidence of adverse effects during the therapies

  2 months

Study Arms (2)

Nd-Yap 1340nm laser

ACTIVE COMPARATOR

The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.

Device: Nd-Yap 1340nm laser

Microneedling

EXPERIMENTAL

The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.

Device: Microneedling

Interventions

Nd-Yap 1340nm laser DEVICE

Each part of the abdomen will be treated with a therapeutic modality. The ND-yap 1340-nm laser will be used in the following parameters: 90 mtz / cm2 nozzle, 90 mJ / mtz power, 2.5 Hz frequency, 3 ms pulse duration, 1 pass.

Also known as: Nonablative Fractional Laser

Nd-Yap 1340nm laser

Microneedling DEVICE

In the other segment of the abdomen, the dermaroller 2.5 mm will be applied, with ten to fifteen passes in the same direction and at least four crosses in the rolling areas.

Also known as: Dermaroller, Percutaneous Collagen Induction Therapy

Microneedling

Eligibility Criteria

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

You may qualify if:

• female patients,
• age 18 and over;
• presenting with abdominal striae rubra diagnosed after clinical examination;
• patients with weight stability in the last four months;
• patients with Fitzpatrick III or IV phototype.

You may not qualify if:

• pregnant women;
• childbirth for less than 12 months;
• history of keloid scars;
• presence of localized or systemic infection;
• presence of immunosuppression;
• use of photosensitizing medications;
• use of systemic steroids;
• use of oral isotretinoin in the last 12 months;
• history of diseases of collagen or elastic fibers;
• hypersensitivity to infiltrative or topical anesthetics;
• patients who have been treated for striae distensae in the last year;
• presence of sun exposure during the study.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator
• MTO Importadora e Distribuidora: collaborator
• Vydence Medical: collaborator
• Aché Laboratórios Farmacêuticos Ltda: collaborator

Study Sites (1)

Ana Paula Naspolini

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (11)

• 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

• Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

  PMID: 15216537 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

• Geronemus RG. Fractional photothermolysis: current and future applications. Lasers Surg Med. 2006 Mar;38(3):169-76. doi: 10.1002/lsm.20310.

  PMID: 16532440 BACKGROUND

• de Angelis F, Kolesnikova L, Renato F, Liguori G. Fractional nonablative 1540-nm laser treatment of striae distensae in Fitzpatrick skin types II to IV: clinical and histological results. Aesthet Surg J. 2011 May;31(4):411-9. doi: 10.1177/1090820X11402493.

  PMID: 21551432 BACKGROUND

• Cachafeiro T, Escobar G, Maldonado G, Cestari T, Corleta O. Comparison of Nonablative Fractional Erbium Laser 1,340 nm and Microneedling for the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Surg. 2016 Feb;42(2):232-41. doi: 10.1097/DSS.0000000000000597.

  PMID: 26845539 BACKGROUND

• Park KY, Kim HK, Kim SE, Kim BJ, Kim MN. Treatment of striae distensae using needling therapy: a pilot study. Dermatol Surg. 2012 Nov;38(11):1823-8. doi: 10.1111/j.1524-4725.2012.02552.x. Epub 2012 Aug 22.

  PMID: 22913429 BACKGROUND

• Hexsel D, Soirefmann M, Porto MD, Schilling-Souza J, Siega C, Dal'Forno T. Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study. Dermatol Surg. 2014 May;40(5):537-44. doi: 10.1111/dsu.12460. Epub 2014 Feb 26.

  PMID: 24612027 BACKGROUND

• Zeitter S, Sikora Z, Jahn S, Stahl F, Strauss S, Lazaridis A, Reimers K, Vogt PM, Aust MC. Microneedling: matching the results of medical needling and repetitive treatments to maximize potential for skin regeneration. Burns. 2014 Aug;40(5):966-73. doi: 10.1016/j.burns.2013.12.008. Epub 2014 Feb 7.

  PMID: 24513133 BACKGROUND

• Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.

  PMID: 18349665 BACKGROUND

• Naspolini AP, Boza JC, da Silva VD, Cestari TF. Efficacy of Microneedling Versus Fractional Non-ablative Laser to Treat Striae Alba: A Randomized Study. Am J Clin Dermatol. 2019 Apr;20(2):277-287. doi: 10.1007/s40257-018-0415-0.

  PMID: 30618025 DERIVED

MeSH Terms

Conditions

Striae Distensae

Interventions

Lasers; Percutaneous Collagen Induction

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; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Tania F Cestari, Dr

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical evaluators will evaluate the photos after the treatments blindly for which type of treatment applied. Evaluators of skin biopsies will be blinded to what type of treatment is applied and for pre-treatment and post-treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will have the abdomen divided equally. Each segment of the abdomen will be randomized using the Excel 2013 program to receive laser or microneedle treatment.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 4, 2018
• Study Start: July 1, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 20, 2018
• Last Updated: August 1, 2018

Record last verified: 2017-06

Locations

BR (1)