facial acne scar acne scar face filler microfocused ultrasound
Conditions
Interventions
One side of the face is randomly selected to receive 1.5mL injection of mixture of calcium hydroxylapatite dermal filler and 2% lidocaine without epinephrine (mixture ratio 1:1),Another side of the fa
hatch pattern. (total 80 lines)
Active Comparator Device,Experimental Device
calcium hydroxylapatite dermal filler only,calcium hydroxylapatite dermal filler and microfocused ultrasound
Sponsors
Division of Dermatology, Ramathibodi Hospital
Merz Healthcare (Thailand) Company Limited
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Moderate severity of acne scar on both side of the face based on Goodman acne scarring classification - Goodman acne scarring classification scores are not differed more than 1 point between both sides of the face. - Cease topical vitamin A derivatives for at least 2 weeks (washout period)
Exclusion criteria
Exclusion criteria: - Having active infection on treatment site - Having open wound on treatment site - Having uncontrolled acne vulgaris - Pregnant or lactating women - Having a history of skin cancer - Having a history of allergy to any filler materials - Immunocompromised - Having history of recurrent herpes infection - Had taken oral vitamin A within 3 months prior to the study initiation - Had chemical peeling within 1 month prior to the study initiation - Had laser or focused ultrasound treatment of the face within 3 months prior to the study initiation - Having dental root diseases or had dental root procedures - Having metal implant on treatment site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar volume Baseline, 2, 4, 8, 12, and 24 weeks after treatment measured using Antera 3D (Miravex Limited, Ireland) in millimetre cubed,Goodman acne scarring classification score 2, 4, 8, 12, and 24 weeks after treatment Dermatologist evaluation of severity of acne scar based on given range of scores,ECCA grading scale 2, 4, 8, 12, and 24 weeks after treatment Dermatologist evaluation of severity of acne scar based on given range of scores | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement score 2, 4, 8, 12, and 24 weeks after treatment Patient evaluation of improvement in severity of acne scar using visual analogue scale,Side effect occurance 2, 4, 8, 12, and 24 weeks after treatment Dermatologist evaluation and patients' feedback | — |
Contacts
Public ContactVasanop Vachiramon
Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital
Outcome results
None listed