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

Primary Purpose

Striae Distensae

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nd-Yap 1340nm laser
Microneedling
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Striae Distensae focused on measuring Striae alba, Microneedling, Fractional nonablative laser, dermaroller, Nd-yap 1340nm laser, Percutaneous Collagen Induction Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ana Paula Naspolini

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nd-Yap 1340nm laser

Microneedling

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical response to microneedle treatment and nonablative fractional laser treatment
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.
Histopatological response in abdominal striae alba after the therapies
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
Histopatological response in abdominal striae alba after the therapies
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
The tolerability and incidence of adverse effects during the therapies
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
The impact on the quality of life provided by the striae distensae
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
The impact on the quality of life provided by the striae distensae
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.
The impact on the quality of life provided by the striae distensae
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.

Full Information

First Posted
December 27, 2017
Last Updated
July 31, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical, Aché Laboratórios Farmacêuticos Ltda
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1. Study Identification

Unique Protocol Identification Number
NCT03390439
Brief Title
Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser
Official Title
Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical, Aché Laboratórios Farmacêuticos Ltda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Distensae
Keywords
Striae alba, Microneedling, Fractional nonablative laser, dermaroller, Nd-yap 1340nm laser, Percutaneous Collagen Induction Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nd-Yap 1340nm laser
Arm Type
Active Comparator
Arm Description
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.
Arm Title
Microneedling
Arm Type
Experimental
Arm Description
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
Intervention Type
Device
Intervention Name(s)
Nd-Yap 1340nm laser
Other Intervention Name(s)
Nonablative Fractional Laser
Intervention Description
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
Intervention Name(s)
Microneedling
Other Intervention Name(s)
Dermaroller, Percutaneous Collagen Induction Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response in abdominal alba striae after the therapies
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical response to microneedle treatment and nonablative fractional laser treatment
Description
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.
Time Frame
4 months
Title
Histopatological response in abdominal striae alba after the therapies
Description
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
Time Frame
4 months
Title
Histopatological response in abdominal striae alba after the therapies
Description
Histopathological evaluation of the thickness of the epidermis, as collagen and elastic (picrosirius stain, orcein stain)
Time Frame
6 months
Title
The tolerability and incidence of adverse effects during the therapies
Description
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Time Frame
1 month
Title
The tolerability and incidence of adverse effects during the therapies
Description
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Time Frame
2 months
Title
The tolerability and incidence of adverse effects during the therapies
Description
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Time Frame
3 months
Title
The tolerability and incidence of adverse effects during the therapies
Description
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Time Frame
4 months
Title
The tolerability and incidence of adverse effects during the therapies
Description
To assess the tolerability and the incidence of immediate and late adverse effects (pain, skin erythema, pruritus) for both techniques
Time Frame
5 months
Title
The impact on the quality of life provided by the striae distensae
Description
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
Time Frame
Pre-treatment (first day of the evaluation)
Title
The impact on the quality of life provided by the striae distensae
Description
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.
Time Frame
4 months
Title
The impact on the quality of life provided by the striae distensae
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania F Cestari, Dr
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Ana Paula Naspolini
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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24125059
Citation
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Results Reference
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22148016
Citation
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.
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derived

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

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