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

Not Applicable

Recruiting

• Conditions: Striae Distensae
• Interventions: Device: Polylevolactic Acid Injection; Device: 1565nm Non-ablative Fractional Laser; Device: Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser

• Registration Number: NCT05827913
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age: 18-50 years old, regardless of gender;
2. The clinical diagnosis was atrophic stria;
3. Patients with normal blood routine, liver and kidney function, and preoperative infection;
4. Able to communicate well with researchers and comply with the overall test requirements;
5. Willing to take and retain photos before and after treatment;
6. Volunteer and sign an informed consent form.

Exclusion Criteria

1. Scar constitution;
2. Acute or chronic skin infections (including bacteria, viruses, and fungi) exist near the treatment area;
3. Those who are allergic to any component of the product;
4. Those who have been injected with anticoagulant drugs;
5. Those who have used other drugs, other substances, and other implant agents;
6. Patients with severe primary and psychiatric disorders such as heart, brain, liver, kidney, hematopoietic system, endocrine system, etc;
7. History of peripheral vascular disease, long-term alcoholism, diabetes, immunosuppression, disorder, drug abuse, etc;
8. Pregnant and lactating women;
9. Those who are critically ill and difficult to accurately evaluate the effectiveness and safety of the product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Polylevolactic Acid Injection	Polylevolactic Acid Injection	Polylevolactic Acid Injection in SD
Fractional Laser	1565nm Non-ablative Fractional Laser	1565nm Non-ablative Fractional Laser treatment in SD
combination treatment	Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser	Polylevolactic Acid injection combined with 1565nm Non-ablative Fractional Laser treatment in SD

Primary Outcome Measures

Name	Time	Method
The treatment effect is judged by color, area, concavity and convexity, and skin elasticity	4months	* Color: Ranked in order as follows: Purple red pink skin color, no change 0 point, 1 point added for each shade subtracted; * Area: 0 point: no change, 1 point: slightly improved, 2 points: significantly improved, 3 points: basically invisible; * Bump sensation: 0 point: no change, 1 point: slightly improved, 2 points: significantly improved, 3 points: bump basically eliminated; * Skin elasticity: 0 point: no change, 1 point: slightly improved, 2 points: significantly improved, 3 points: very satisfied; The total score of 6-12 points is basically cured; A total score of 3-5 points is significant; Effective with a total score of 1-2; A total score ≤ 1 is invalid.; Total effective rate of treatment=(basically cured+significantly effective+effective)/total number of cases × 100%.; Higher scores mean a better outcome.

Trial Locations

Locations (1)

Dermatology Derpartment of Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China