NCT05827913

Efficacy and Safety of Polylevolactic Acid Injection Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae

Evaluation of the Efficacy and Safety of Polylevolactic Acid Injection Filling Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

1. Striae distensae (SD), also known as stretch marks, are common, permanent dermal lesions that can be symptomatic and are considered aesthetically undesirable; thus, they pose a significant psychosocial and therapeutic challenge. SD arise in areas of dermal stretching and most commonly occur on the abdomen, breasts, buttocks, and thighs. Most literature has described SD during pregnancy(striae gravidarum) and puberty, with reported prevalences varying from 11% to 88%. Hormonal influences, reduced genetic expression of fibronectin, collagen, and elastin, and mechanical stretching of the skin have all been postulated to contribute to SD formation. In the acute phase, SD appear as red/violaceous lesions (striae rubrae; SR) that can be raised and symptomatic. The chronic form (striae albae; SA) exists as hypopigmented dermal depressions. 2. Polylevolactic Acid(PLLA) is at present one of the most promising biodegradable polymers (biopolymers) and has been the subject of abundant literature over the last decade. PLLA can be processed with a large number of techniques and is commercially available (large-scale production) in a wide range of grades. 3. Previous studies have found that 1565-nm laser can promote the synthesis of types I, III, and VII collagen and elastin, as well as the remodeling of dermal collagen. According to previous studies, dermal collagen deposition and remodeling may be related to the mechanism by which 1565-nm laser improves SD.

Conditions

• Striae Distensae

Interventions

Type	Name	Description
DEVICE	Polylevolactic Acid Injection	The patient was placed in a flat recumbent position and subjected to topical anesthesia with lidocaine cream for those who were unable to tolerate pain. According to the location and degree of indentation of the atrophic stria, a conventional disinfection towel is placed and injected into the subcutaneous and deep dermis. Use left thumb and index finger to press or tighten the skin from both sides to the middle. Depending on the location of the SD, determine the injection direction. During linear injection, the injection starts from the distal end of the SD, and then the injection is withdrawn until the SD subsides. Apply uniform force and withdraw the needle at a uniform speed. Stop the injection before the needle is pulled out of the skin, To avoid too shallow an injection.
DEVICE	1565nm Non-ablative Fractional Laser	M22-ResurFx laser (Lumenis Medical Company, USA) was used for treatment, with a wavelength of 1565 nm, a selected energy of 45 mJ, and a lattice density of 200 dots/cm2. The end point reaction was erythema and wind masses at the treatment site.
DEVICE	Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser	combination of the two treatments described above

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: China