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

ID: NCT03390439
Status: Active, not recruiting
Phase: N/A
Start Date: July 01, 2017
First Submitted: December 27, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Hospital de Clinicas de Porto Alegre, Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical and 1 more..
Location: Brazil
Conditions: Striae Distensae
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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.
Condition or disease Intervention/treatment Phase

Striae Distensae

Device: Nd-Yap 1340nm laser
Other Names
Nonablative Fractional Laser
Device: Microneedling
Other Names
Dermaroller Percutaneous Collagen Induction Therapy
N/A

Tracking Information

First Submitted DateDecember 27, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateJuly 01, 2017
Anticipated Completion DateApril 20, 2018
Actual Primary Completion DateApril 10, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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.

  • 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)

  • 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)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleTreatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser
Official TitleTreatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
20
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Striae Distensae
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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
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
Study Groups/Cohorts
Nd-Yap 1340nm laser
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.

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

Study Arms
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.

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.

Arm Intervention/Treatment
Experimental Microneedling
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
Device : Microneedling
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

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment20
Completion DateApril 20, 2018
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.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Brazil

Administrative Information

NCT Number:NCT03390439
Other Study ID Numbers
47639415.1.0000.5327
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
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 Clínicas de Porto Alegre

Publications