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

Striae Distensae Clinical Trial

Official title:

Treatment of Atrofic Striae With Percutaneous Collagen Induction Therapy Versus Fractional Nonablative Laser: a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390439
• Other study ID #: 47639415.1.0000.5327
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: June 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 20, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Striae Distensae

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.
• 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.

Locations

Country	Name	City	State
Brazil	Ana Paula Naspolini	Porto Alegre	Rio Grande Do Sul

Sponsors (5)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Aché Laboratórios Farmacêuticos Ltda, Associação Fundo de Incentivo à Pesquisa, MTO Importadora e Distribuidora, Vydence Medical

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

Al-Himdani S, Ud-Din S, Gilmore S, Bayat A. Striae distensae: a comprehensive review and evidence-based evaluation of prophylaxis and treatment. Br J Dermatol. 2014 Mar;170(3):527-47. doi: 10.1111/bjd.12681. Review. — View 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):1421-9. doi: 10.1097/01.prs.0000304612.72899.02. — View Citation

Cachafeiro T, Escobar G, Maldonado G, Cestari T, Corleta O. Comparison of Nonablative Fractional Erbium Laser 1,340 nm and Microneedling for the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Surg. 2016 Feb;42(2):232-41. doi: 10.1097/DSS.0000000000000597. — View Citation

de Angelis F, Kolesnikova L, Renato F, Liguori G. Fractional nonablative 1540-nm laser treatment of striae distensae in Fitzpatrick skin types II to IV: clinical and histological results. Aesthet Surg J. 2011 May;31(4):411-9. doi: 10.1177/1090820X11402493. — View Citation

Geronemus RG. Fractional photothermolysis: current and future applications. Lasers Surg Med. 2006 Mar;38(3):169-76. — View 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. — View Citation

Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. — View Citation

Park KY, Kim HK, Kim SE, Kim BJ, Kim MN. Treatment of striae distensae using needling therapy: a pilot study. Dermatol Surg. 2012 Nov;38(11):1823-8. doi: 10.1111/j.1524-4725.2012.02552.x. Epub 2012 Aug 22. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	4 months
Secondary	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)	4 months
Secondary	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)	6 months
Secondary	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	1 month
Secondary	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	2 months
Secondary	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	3 months
Secondary	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	4 months
Secondary	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	5 months
Secondary	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	Pre-treatment (first day of the evaluation)
Secondary	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.	4 months
Secondary	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.	6 months