Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser
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| ClinicalTrials.gov Identifier: NCT03390439 |
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Recruitment Status :
Completed
First Posted : January 4, 2018
Last Update Posted : August 1, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Striae Distensae | Device: Nd-Yap 1340nm laser Device: Microneedling | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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: | Double (Investigator, Outcomes 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. |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial |
| Actual Study Start Date : | July 1, 2017 |
| Actual Primary Completion Date : | April 10, 2018 |
| Actual Study Completion Date : | April 20, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 Name: Nonablative Fractional Laser |
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Experimental: Microneedling
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
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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:
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- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390439
| Brazil | |
| Ana Paula Naspolini | |
| Porto Alegre, Rio Grande Do Sul, Brazil, 90035903 | |
| Study Director: | Tania F Cestari, Dr | Hospital de Clínicas de Porto Alegre |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospital de Clinicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT03390439 |
| Other Study ID Numbers: |
47639415.1.0000.5327 |
| First Posted: | January 4, 2018 Key Record Dates |
| Last Update Posted: | August 1, 2018 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Striae alba Microneedling Fractional nonablative laser |
dermaroller Nd-yap 1340nm laser Percutaneous Collagen Induction Therapy |
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Striae Distensae Skin Manifestations |