NCT05827913

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

Status unknown NA Last updated 25 April 2023

What this trial tests

NA trial testing Polylevolactic Acid Injection in Striae Distensae in 30 participants. Status unknown.

Timeline

1 March 2023

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	Xijing Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 March 2023
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across China

Drugs / interventions tested

• Polylevolactic Acid Injection
• 1565nm Non-ablative Fractional Laser
• Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser

Conditions studied

• Striae Distensae — all drugs for Striae Distensae →

Sponsor

Xijing Hospital

Who can join

Adults 18 to 50, any sex, with Striae Distensae. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Efficacy Comparisons Between Poly-L-Lactic Acid Injections and Non-Ablative 1565-nm Fractional Laser for Treatment of Striae Distensae-A Randomized Trial.
   Qu H, Wang L, Xin W, Lu M, et al · · 2025 · cited 1× · PMID 40662320 · DOI 10.1111/jocd.70338