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

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Striae Distensae

Treatments: Device: Nd-Yap 1340nm laser; Device: Microneedling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03390439

47639415.1.0000.5327

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Nd-Yap 1340nm laser

Active Comparator group

Description:

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

Treatment:

Device: Nd-Yap 1340nm laser

Microneedling

Experimental group

Description:

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

Treatment:

Device: Microneedling