Women who have white stretch mark (Striae Alba) around abdominal area after pregnancy Stretch mark, Biostimulator, PDLLA, Poly-D, L-Lactid Acid
Conditions
Interventions
Compare efficacy between Poly-D, L-Lactic Acid (PDLLA) injection and Normal Saline Solution (NSS) injection
1 Vial of Product consist of PDLLA 150 mg mix with 9 ml SWFI : 1 ml lidocaine (Split Side -
Efficacy of Poly-D, L-Lactic Acid (PDLLA) injection to Stretch Mark,Efficacy of Normal Saline Solution (NSS) injection to Stretch Mark
Sponsors
K.N.A INTER PHARMA Co.,Ltd
Eligibility
Sex/Gender
Female
Age
25 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Female Thai volunteers with abdominal striae distensae following pregnancy, aged between 25 to 50 years, 2.Participants who desire to improve post-pregnancy abdominal striae, 3.Participants who are able to complete the entire 20-week study period, 4.Participants who voluntarily agree to participate in the study and provide written informed consent, 5.Only participants with white striae (Striae Alba stage) on the abdomen will be included
Exclusion criteria
Exclusion criteria: 1.Participants who have undergone abdominal surgery, received topical or injectable treatments, or undergone laser therapy for abdominal striae within 6 months prior to study enrollment, 2.Participants with a history of keloid formation or hypertrophic scarring, 3.Participants with skin infections near the intended injection site, 4.Participants with bleeding disorders, collagen synthesis disorders, or genetic abnormalities related to collagen production, 5.Participants with a history of allergy to lidocaine (injectable or topical anesthetic), PDLLA, or any component of the investigational product, 6.Pregnant or breastfeeding women, or those with a likelihood of becoming pregnant, 7.Participants with red abdominal striae (Striae Rubra stage), 8.Participants with mixed red and white abdominal striae (Striae Rubra and Striae Alba stages)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume 0, 4, 8, 12, 20 Week Antera 3D,Roughness 0, 4, 8, 12, 20 Week Antera 3D,Wrinkle 0, 4, 8, 12, 20 Week Antera 3D,Pigmentation 0, 4, 8, 12, 20 Week Antera 3D,Striae Distensae Severity Scale 0, 20 Week Photo of Stretch Mark (Abdominal Area),Global Aesthetic Improvement Scale (GAIS) 0, 20 Week Photo of Stretch Mark (Abdominal Area) | — |
Secondary
| Measure | Time frame |
|---|---|
| Swelling at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Bruising at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Redness at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Itching at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Formation of nodules at the injection site 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Skin discoloration at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF),Pain score at the injection site 24 hour, 48 hour, 4 week, 8 week, 12 week, 20 week Case Record Form (CRF) | — |
Countries
Thailand
Contacts
Public ContactPansak Sugkraroek
College of Integrative Medicine (CIM), Dhurakij Pundit University
Outcome results
None listed