Clinical trial NCT03390439: 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
Overall status: COMPLETED
Phase: NA
Conditions: Striae Distensae
Keywords: Striae alba
Microneedling
Fractional nonablative laser
dermaroller
Nd-yap 1340nm laser
Percutaneous Collagen Induction Therapy
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
name: MTO Importadora e Distribuidora
name: Vydence Medical
name: Aché Laboratórios Farmacêuticos Ltda
First posted: 2018-01-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical response in abdominal alba striae after the therapies
timeFrame: 6 months
Secondary outcomes:
measure: Clinical response to microneedle treatment and nonablative fractional laser treatment
timeFrame: 4 months
measure: Histopatological response in abdominal striae alba after the therapies
timeFrame: 4 months
measure: Histopatological response in abdominal striae alba after the therapies
timeFrame: 6 months
measure: The tolerability and incidence of adverse effects during the therapies
timeFrame: 1 month
measure: The tolerability and incidence of adverse effects during the therapies
timeFrame: 2 months
measure: The tolerability and incidence of adverse effects during the therapies
timeFrame: 3 months
measure: The tolerability and incidence of adverse effects during the therapies
timeFrame: 4 months
measure: The tolerability and incidence of adverse effects during the therapies
timeFrame: 5 months
measure: The impact on the quality of life provided by the striae distensae
timeFrame: Pre-treatment (first day of the evaluation)
measure: The impact on the quality of life provided by the striae distensae
timeFrame: 4 months
measure: The impact on the quality of life provided by the striae distensae
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Ana Paula Naspolini
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Tania F Cestari, Dr
role: STUDY_DIRECTOR
References:
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citation: Hexsel D, Soirefmann M, Porto MD, Schilling-Souza J, Siega C, Dal'Forno T. Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study. Dermatol Surg. 2014 May;40(5):537-44. doi: 10.1111/dsu.12460. Epub 2014 Feb 26.
citation: Zeitter S, Sikora Z, Jahn S, Stahl F, Strauss S, Lazaridis A, Reimers K, Vogt PM, Aust MC. Microneedling: matching the results of medical needling and repetitive treatments to maximize potential for skin regeneration. Burns. 2014 Aug;40(5):966-73. doi: 10.1016/j.burns.2013.12.008. Epub 2014 Feb 7.
citation: Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.
citation: Naspolini AP, Boza JC, da Silva VD, Cestari TF. Efficacy of Microneedling Versus Fractional Non-ablative Laser to Treat Striae Alba: A Randomized Study. Am J Clin Dermatol. 2019 Apr;20(2):277-287. doi: 10.1007/s40257-018-0415-0.