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Status unknownNCT05827913Updated Apr 25, 2023

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

An interventional study of Polylevolactic Acid Injection and 1565nm Non-ablative Fractional Laser in Striae Distensae, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study 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.
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Conditions studied

  • Striae Distensae

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Keywords

  • Polylevolactic Acid
  • Striae Distensae
  • 1565nm Non-ablative Fractional Laser
  • treatment
03

In context

Striae Distensae

39 studies on the registry are indexed under Striae Distensae; 6 are open to participants now.

This study's planned enrollment of 30 is close to the median of 28 across 38 interventional studies indexed under Striae Distensae.

Browse Striae Distensae studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Polylevolactic Acid Injection

    Polylevolactic Acid Injection in SD

    Device: Polylevolactic Acid Injection

  • Active comparator
    Fractional Laser

    1565nm Non-ablative Fractional Laser treatment in SD

    Device: 1565nm Non-ablative Fractional Laser

  • Active comparator
    combination treatment

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

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

Interventions

  • DevicePolylevolactic 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.

  • Device1565nm 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.

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

    combination of the two treatments described above

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What researchers measure

Primary outcomes

  1. The treatment effect is judged by color, area, concavity and convexity, and skin elasticity

    * 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.

    Time frame: 4months

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Study locations

1 of 1 sites recruiting
  • Dermatology Derpartment of Xijing Hospital
    Xi'an, Shaanxi 710032, China
    • Gang Wang · Contact · +8684775401
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05827913
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Apr 25, 2023
Start date
Mar 1, 2023
Primary completion
Mar 1, 2024 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Apr 25, 2023

Study contacts

Lin Gao, PhD
Contact
gaolin@fmmu.edu.cn
+8602984775401 ext. 029
Chen Yu, PhD
Contact
ycyc-2005@163.com
_8613571991903 ext. 029
Gang Wang, Prof
principal investigator · Dermatology Department of Xijing Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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