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

Primary Purpose

Striae Distensae

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Polylevolactic Acid Injection
1565nm Non-ablative Fractional Laser
Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Striae Distensae focused on measuring Polylevolactic Acid, Striae Distensae, 1565nm Non-ablative Fractional Laser, treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-50 years old, regardless of gender; The clinical diagnosis was atrophic stria; Patients with normal blood routine, liver and kidney function, and preoperative infection; Able to communicate well with researchers and comply with the overall test requirements; Willing to take and retain photos before and after treatment; Volunteer and sign an informed consent form. Exclusion Criteria: Scar constitution; Acute or chronic skin infections (including bacteria, viruses, and fungi) exist near the treatment area; Those who are allergic to any component of the product; Those who have been injected with anticoagulant drugs; Those who have used other drugs, other substances, and other implant agents; Patients with severe primary and psychiatric disorders such as heart, brain, liver, kidney, hematopoietic system, endocrine system, etc; History of peripheral vascular disease, long-term alcoholism, diabetes, immunosuppression, disorder, drug abuse, etc; Pregnant and lactating women; Those who are critically ill and difficult to accurately evaluate the effectiveness and safety of the product.

Sites / Locations

  • Dermatology Derpartment of Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Polylevolactic Acid Injection

Fractional Laser

combination treatment

Arm Description

Polylevolactic Acid Injection in SD

1565nm Non-ablative Fractional Laser treatment in SD

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2023
Last Updated
April 24, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05827913
Brief Title
Efficacy and Safety of Polylevolactic Acid Injection Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae
Official Title
Evaluation of the Efficacy and Safety of Polylevolactic Acid Injection Filling Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Distensae
Keywords
Polylevolactic Acid, Striae Distensae, 1565nm Non-ablative Fractional Laser, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polylevolactic Acid Injection
Arm Type
Experimental
Arm Description
Polylevolactic Acid Injection in SD
Arm Title
Fractional Laser
Arm Type
Active Comparator
Arm Description
1565nm Non-ablative Fractional Laser treatment in SD
Arm Title
combination treatment
Arm Type
Active Comparator
Arm Description
Polylevolactic Acid injection combined with 1565nm Non-ablative Fractional Laser treatment in SD
Intervention Type
Device
Intervention Name(s)
Polylevolactic Acid Injection
Intervention Description
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
Intervention Name(s)
1565nm Non-ablative Fractional Laser
Intervention Description
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
Intervention Name(s)
Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser
Intervention Description
combination of the two treatments described above
Primary Outcome Measure Information:
Title
The treatment effect is judged by color, area, concavity and convexity, and skin elasticity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-50 years old, regardless of gender; The clinical diagnosis was atrophic stria; Patients with normal blood routine, liver and kidney function, and preoperative infection; Able to communicate well with researchers and comply with the overall test requirements; Willing to take and retain photos before and after treatment; Volunteer and sign an informed consent form. Exclusion Criteria: Scar constitution; Acute or chronic skin infections (including bacteria, viruses, and fungi) exist near the treatment area; Those who are allergic to any component of the product; Those who have been injected with anticoagulant drugs; Those who have used other drugs, other substances, and other implant agents; Patients with severe primary and psychiatric disorders such as heart, brain, liver, kidney, hematopoietic system, endocrine system, etc; History of peripheral vascular disease, long-term alcoholism, diabetes, immunosuppression, disorder, drug abuse, etc; Pregnant and lactating women; Those who are critically ill and difficult to accurately evaluate the effectiveness and safety of the product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Gao, PhD
Phone
+8602984775401
Ext
029
Email
gaolin@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Yu, PhD
Phone
_8613571991903
Ext
029
Email
ycyc-2005@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, Prof
Organizational Affiliation
Dermatology Department of Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Derpartment of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wang
Phone
+8684775401

12. IPD Sharing Statement

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

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