An interventional study of Nd-Yap 1340nm laser and Microneedling in Striae Distensae, sponsored by Hospital de Clinicas de Porto Alegre. Completed at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Striae Distensae; 7 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 43 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of Nd-yap 1340nm laser.
Device: Nd-Yap 1340nm laser
The randomly assigned segment of the abdomen will receive 5 sessions with monthly intervals of dermaroller 2,5mm.
Device: Microneedling
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.
Also known as: Nonablative Fractional Laser
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.
Also known as: Dermaroller, Percutaneous Collagen Induction Therapy
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.
Time frame: 6 months
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.
Time frame: 4 months
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)
Time frame: 4 months
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)
Time frame: 6 months
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
Time frame: 1 month
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
Time frame: 2 months
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
Time frame: 3 months
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
Time frame: 4 months
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
Time frame: 5 months
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
Time frame: Pre-treatment (first day of the evaluation)
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.
Time frame: 4 months
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.
Time frame: 6 months
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Apr 2018, 9 months.
Of 22 interventional studies with no phase under Striae Distensae, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 58. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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