Efficacy and safety of using combination of non-insulated microneedle radiofrequency alone compared to combination with polynucleotides for the treatment of periorbital wrinkle. A pilot study

Phase 3

• Conditions: Periorbital wrinkle; non- insulated microneedle radiofrequency; polynucleotides; periorbital wrinkle

• Registration Number: TCTR20201105007
• Lead Sponsor: DS Medical Systems (Thailand) Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Study Completion: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Fitzpatrick skin type 3-5
Class 1-2 of Fitzpatrick’s Classification of Facial Wrinkling (Periorbital)

Exclusion Criteria

Allergy to hyaluronic acid or polynucleotide
Pregnancy, Breast feeding, or postpartum within 3 months
Has skin infection at periorbital area
Using steroid, anticoagulant, anti platelet and ginkgo
Smoking
History of hypertrophic scar or keloid

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of using combination of non-insulated microneedle RF with polynucleotides baseline, 2 wk, 4 wk, 6 wk, 8 wk, 12 wk, 16 wk, 28 wk Photograph, Antera, Visioscan, Cutometer, Mexameter

Secondary Outcome Measures

Name	Time	Method
Safety of using combination of non-insulated microneedle RF with polynucleotides baseline, 2 wk, 4 wk, 6 wk, 8 wk, 12 wk, 16 wk, 28 wk VAS, Side effect