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

NCT ID: NCT03390439

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-04-20

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.

Detailed Description

Twenty patients will be treated at the dermatologic clinic of the Hospital de Clínicas de Porto Alegre (HCPA). Each patient will be treated with laser and microneedle at the same time, being applied a therapeutic procedure in each part of the abdomen (divided lengthwise and in equal parts). Each part of the abdomen will be randomized for the treatment of laser or microneedling with the help of the Excel 2013 program. The investigator responsible for procedures and patients are the only ones with unblinded assessment in relation to the side of each treatment. There will be 5 sessions with monthly intervals of the proposed treatments. The ND-yap 1340-nm laser will be used, and in the other segment of the abdomen, the dermaroller 2.5 mm was applied. Photographic records of patients will be performed at pre-treatment and 1 month after the third and fifth sessions. The questionnaires will be applied to assess the quality of life in dermatology DLQI (Dermatology Life Quality Index). Two independent and blind evaluators for the type of treatment will apply in the Global Aesthetic Scale (GAIS) in the evaluation of photographic records. Cutaneous biopsies for histopathological evaluation will be performed with a punch 3 mm of each part of the abdomen at pretreatment. Two experienced pathologists will evaluate the measurements of the epidermis and the collagen and elastic fibers of the skin.

Conditions

Striae Distensae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nd-Yap 1340nm laser

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

Group Type: ACTIVE_COMPARATOR

Nd-Yap 1340nm laser

Intervention Type: 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.

Microneedling

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

Group Type: EXPERIMENTAL

Microneedling

Intervention Type: 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.

Interventions

Nd-Yap 1340nm laser

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.

Intervention Type: DEVICE

Microneedling

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.

Intervention Type: DEVICE

Other Intervention Names

Nonablative Fractional Laser; Dermaroller; Percutaneous Collagen Induction Therapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

MTO Importadora e Distribuidora

UNKNOWN

Sponsor Role: collaborator

Vydence Medical

UNKNOWN

Sponsor Role: collaborator

Aché Laboratórios Farmacêuticos Ltda

INDUSTRY

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tania F Cestari, Dr

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Ana Paula Naspolini

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15216537 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 30618025 (View on PubMed)

Other Identifiers

47639415.1.0000.5327

Identifier Type: -

Identifier Source: org_study_id