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NCT Number: NCT03390439

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

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.

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Key information

Conditions

Striae Distensae Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ana Paula Naspolini

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Nonablative Fractional 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.

Other names: Dermaroller, Percutaneous Collagen Induction Therapy

Primary outcomes

  1. Clinical response in abdominal alba striae after the therapies

    Time frame: 6 months

    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.

Secondary outcomes

  1. Clinical response to microneedle treatment and nonablative fractional laser treatment

    Time frame: 4 months

    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, not changed and worse.

  2. Histopatological response in abdominal striae alba after the therapies

    Time frame: 4 months

    Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)

  3. Histopatological response in abdominal striae alba after the therapies

    Time frame: 6 months

    Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)

  4. The tolerability and incidence of adverse effects during the therapies

    Time frame: 1 month

    To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques

  5. The tolerability and incidence of adverse effects during the therapies

    Time frame: 2 months

    To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques

  6. The tolerability and incidence of adverse effects during the therapies

    Time frame: 3 months

    To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques

  7. The tolerability and incidence of adverse effects during the therapies

    Time frame: 4 months

    To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques

  8. The tolerability and incidence of adverse effects during the therapies

    Time frame: 5 months

    To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques

  9. The impact on the quality of life provided by the striae distensae

    Time frame: Pre-treatment (first day of the evaluation)

    To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life

  10. The impact on the quality of life provided by the striae distensae

    Time frame: 4 months

    To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life.

  11. The impact on the quality of life provided by the striae distensae

    Time frame: 6 months

    To evaluate the impact on the quality of life (DLQI) provided by the striae. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.

    The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    0-1: no effect at all on patient's life 2-5: small effect on patient's life 6-10: moderate effect on patient's life 11-20: very large effect on patient's life 21-30:extremely large effect on patient's life.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Aché Laboratórios Farmacêuticos Ltda
  • Associação Fundo de Incentivo à Pesquisa
  • MTO Importadora e Distribuidora
  • Vydence Medical

Registry information

Official study title

Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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