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

NCT ID: NCT05827913

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-01

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.

Conditions

Striae Distensae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Polylevolactic Acid Injection

Polylevolactic Acid Injection in SD

Group Type: EXPERIMENTAL

Polylevolactic Acid Injection

Intervention Type: DEVICE

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.

Fractional Laser

1565nm Non-ablative Fractional Laser treatment in SD

Group Type: ACTIVE_COMPARATOR

1565nm Non-ablative Fractional Laser

Intervention Type: DEVICE

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.

combination treatment

Polylevolactic Acid injection combined with 1565nm Non-ablative Fractional Laser treatment in SD

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

combination of the two treatments described above

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

combination of the two treatments described above

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Department of Xijing Hospital

Locations

Dermatology Derpartment of Xijing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Gao, PhD

Role: CONTACT

gaolin@fmmu.edu.cn

+8602984775401 ext. 029

Chen Yu, PhD

Role: CONTACT

ycyc-2005@163.com

_8613571991903 ext. 029

Facility Contacts

Gang Wang

Role: primary

+8684775401

References

Qu H, Wang L, Xin W, Lu M, Jing H, Wang G, Gao L. Clinical Efficacy Comparisons Between Poly-L-Lactic Acid Injections and Non-Ablative 1565-nm Fractional Laser for Treatment of Striae Distensae-A Randomized Trial. J Cosmet Dermatol. 2025 Jul;24(7):e70338. doi: 10.1111/jocd.70338.

Reference Type: DERIVED

PMID: 40662320 (View on PubMed)

Other Identifiers

XijingH-PF-KY20232083

Identifier Type: -

Identifier Source: org_study_id