A Comparative Study of Calcium Hydroxylapatite Dermal Filler as Monotherapy and as Combination Therapy with Microfocused Ultrasound for Facial Acne Scar Treatment

Phase 4

Recruiting

• Conditions: facial acne scar; acne scar; face; filler; microfocused ultrasound

• Registration Number: TCTR20190417008
• Lead Sponsor: Division of Dermatology, Ramathibodi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-17
• Study Completion: 2020-02-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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