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A Study of Combined Microneedle Radiofrequency with Poly D, L Lactic Acid Filler for The Treatment of striae: a randomized-controlled trial

A Study of Combined Microneedle Radiofrequency with Poly D, L Lactic Acid Filler for The Treatment of striae: a randomized-controlled trial

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250115003
Enrollment
15
Registered
2025-01-15
Start date
2024-09-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants who desired to treat the striae microneedle radiofrequency, hyaluronic acid, striae

Interventions

After the striae was treated with the first session of microneedle radiofrequency, the random striae was injected with hyaluronic acid/ Poly D, L lactic acid filler injection via blunt-tip cannula si
Combined Microneedle radiofrequency with single hyaluronic acid/ Poly D, L lactic acid filler injection,Microneedle radiofrequency

Sponsors

Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital
Lead Sponsor
Juvetek co., Ltd
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Participants must be 18 years or older, male or female. 2. Participants must be in good general health with no serious underlying medical conditions. 3. Participants must have visible stretch marks (striae distensae) on areas such as the shoulders, abdomen, hips, or thighs. These stretch marks can be both red (striae rubra) and/or white (striae alba) and should be symmetrical. 4. Participants must be able to attend scheduled appointments and follow the study protocol. 5. Participants must voluntarily agree to participate in the study by signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Stretch marks caused by the use of corticosteroids. 2. Participants with any infection, inflammation, or other skin conditions at the treatment site. 3. Participants with a history of allergies to fillers. 4. Participants with pacemakers or metallic prostheses in the treatment area. 5. Participants with a history of hypertrophic scars or keloids. 6. Pregnant or breastfeeding women. 7. Participants who have undergone laser treatments, dermabrasion, chemical peels, radiofrequency treatments, or other procedures on the treatment area within the past 6 months. 8. Participants who have used corticosteroids, immunosuppressants, vitamin A derivatives, vitamin C, or vitamin E within the past 3 months. 9. Participants who decline to participate or withdraw from the study.

Design outcomes

Primary

MeasureTime frame
Width of the widest striae measurement before the treatment, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after the first session of treatment Using verneir caliper measure the width of the widest striae

Secondary

MeasureTime frame
Efficacy by Manchester scar scale before the treatment, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after the first session of treatment Evaluated by two-blinded dermatologists using Manchester scar scale,Scar volume depression before the treatment, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after the first session of treatment Using Antera3D camera and Antera3D program measure the scar volume depression,Pain score after the first session of treatment of both arms using visual analog scale (0-10),Overall satisfaction score before the treatment, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after the first session of treatment Using overall satisfaction score (1 mean very unsatisfied, 2 unsatisfied, 3 neither satisfied nor unsatisfied, 4 satisfied, 5 very satisfied),Global Aesthetic Improvement Scale 4, 8, 12, 16, 20, 24, 28 and 32 weeks after the first session of treatment Evaluated by two-blinded dermatologists using Global Aesthetic Improvement Scale (1 very unsatisfied, 2 unsatisfied, 3 neither satisfied nor unsatisfied, 4 satisfied, 5 very satisfied)

Countries

Thailand

Contacts

Public ContactVasanop Vachiramon

Faculty of Medicine, Ramathibodi hospital

vasanop@gmail.com0946369165

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026