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

July 31, 2018 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
        • Ana Paula Naspolini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nd-Yap 1340nm laser
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.
Device: 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.
Other Names:
  • Nonablative Fractional Laser
Experimental: Microneedling
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
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.
Other Names:
  • Dermaroller
  • Percutaneous Collagen Induction Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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)
4 months
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)
6 months
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
1 month
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
2 months
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
3 months
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
4 months
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
5 months
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
Pre-treatment (first day of the evaluation)
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.
4 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

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

Investigators

  • Study Director: Tania F Cestari, Dr, Hospital De Clinicas De Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

April 10, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47639415.1.0000.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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