Striae DistensaeNCT05827913
Efficacy and Safety of Polylevolactic Acid Injection Combined With 1565nm Non-ablative Fractional Laser in the Treatment of Striae Distensae
A study testing Polylevolactic Acid Injection, 1565nm Non-ablative Fractional Laser and Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser in people with Striae Distensae, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Polylevolactic Acid Injection, 1565nm Non-ablative Fractional Laser and Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Wang, +8684775401
About this study
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
- 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.
- Conditions
- Striae Distensae
- Being tested
- Polylevolactic Acid Injection, 1565nm Non-ablative Fractional Laser, Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser
- Keywords
- Polylevolactic Acid, Striae Distensae, 1565nm Non-ablative Fractional Laser, treatment
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polylevolactic Acid InjectionDevice
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.
1565nm Non-ablative Fractional LaserDevice
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.
Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional LaserDevice
combination of the two treatments described above
| Study group | Role | What they receive |
|---|---|---|
| Polylevolactic Acid Injection | Experimental | Polylevolactic Acid Injection in SD Receives: Device: Polylevolactic Acid Injection |
| Fractional Laser | Active comparator | 1565nm Non-ablative Fractional Laser treatment in SD Receives: Device: 1565nm Non-ablative Fractional Laser |
| combination treatment | Active comparator | Polylevolactic Acid injection combined with 1565nm Non-ablative Fractional Laser treatment in SD Receives: Device: Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Prof, Principal investigator, Dermatology Department of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827913
- Sponsor's protocol ID
- XijingH-PF-KY20232083
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40662320
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05827913
- Acronym / sponsor ID
- XijingH-PF-KY20232083
- Conditions
- Striae Distensae
- Keywords
- Polylevolactic Acid, Striae Distensae, 1565nm Non-ablative Fractional Laser, treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polylevolactic Acid Injection | Experimental | Device: Polylevolactic Acid InjectionPolylevolactic Acid Injection in SD |
| Fractional Laser | Active comparator | Device: 1565nm Non-ablative Fractional Laser1565nm Non-ablative Fractional Laser treatment in SD |
| combination treatment | Active comparator | Device: Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional LaserPolylevolactic Acid injection combined with 1565nm Non-ablative Fractional Laser treatment in SD |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polylevolactic Acid InjectionThe 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. | Device | Polylevolactic Acid Injection |
| 1565nm Non-ablative Fractional LaserM22-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. | Device | Fractional Laser |
| Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Lasercombination of the two treatments described above | Device | combination treatment |
Primary outcome
The treatment effect is judged by color, area, concavity and convexity, and skin elasticity
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 40662320Qu 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.
Related trials for Striae Distensae
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Prevention of Stretch Marks in Expectant Mothers
Pregnant Women, Stretch Mark
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, Prof principal investigator
Dermatology Department of Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polylevolactic Acid Injection, 1565nm Non-ablative Fractional Laser and Polylevolactic Acid Injection combined with 1565nm Non-ablative Fractional Laser in people with Striae Distensae, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Gao, PhD (+8602984775401 ext. 029, gaolin@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment effect is judged by color, area, concavity and convexity, and skin elasticity (time frame: 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.