striae striae, PDLLA
Conditions
Interventions
Treatments will be administered using a 25G, 50 mm blunt cannula into the deep dermis with a fanning technique. Three treatment sessions will be performed at 1 month intervals.,PDLLA (150 mg/vial) wil
Active Comparator Device,Experimental Device
Normal saline control,Poly-D, L-Lactic Acid (PDLLA)
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 20 to 60 years. 2. Presence of bilateral striae distensae on the thighs for at least 3 months. 3. Thai individuals of Asian ethnicity.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Subjects with a history of platelet disorders, coagulation disorders, anemia, liver disease, malignancy, or immunodeficiency disorders. 3. Current smokers or subjects with a history of heavy alcohol consumption. 4. Presence of dermatitis, wounds, or skin infections in the treatment area. 5. History of allergy to local anesthetics. 6. Current use of hormonal therapy, oral contraceptives (oral or injectable), or regular use of nonsteroidal anti-inflammatory drugs (NSAIDs). 7. Current use of medications affecting blood coagulation, such as aspirin or anticoagulants. 8. History of laser treatment on the thighs within 6 months prior to study enrollment. 9. History of hypertrophic scars or keloids. 10. Diagnosed psychiatric disorders confirmed by a psychiatrist. 11. History of autoimmune disease. 12. Current use of immunosuppressive medications. 13. History of severe allergic reactions (anaphylaxis). 14. Use of vitamin E, fish oil supplements, or other agents that may affect platelet function within 2 weeks prior to enrollment. 15. Subjects unwilling to allow photographic documentation for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Texture Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Antera3D,Wrinkles Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Antera3D | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin pliability Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Cutometer,Skin elasticity Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Cutometer,Melanin index Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Mexameter,Erythema index Baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Mexameter,Physician improvement assessment compared to baseline 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Quartile scale,Participants improvement assessment compared to baseline 1 month after 1st treatment, 1 month after 2nd treatment, 1, 3, 6, 9 and 12 months after 3rd treatment Quartile scale,Safety 1st, 2nd and 3rd treatment Adverse events | — |
Countries
Thailand
Contacts
Public ContactThanya Techapichetvanich
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed