search
Back to results

Effects of RF Microneedle on Photoaging Skin

Primary Purpose

Pigmentation, Pigmentation Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RF Microneedle
Combination cream
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigmentation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Adult more than 19 years old Melasma clinically diagnosed by three dermatologists Exclusion Criteria: Aesthetic medical procedures in three months prior to the study Use of topical depigmenting agents in three months prior to the study Pregnant or lactating

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional therapy with RF microneedle

Conventional therapy

Arm Description

Half face Oral tranexamic acid combined with triple combination cream with RF microneedle

Half face Oral tranexamic acid combined with triple combination cream

Outcomes

Primary Outcome Measures

Change of modified melasma area severity index score
Change of modified melasma area severity index score
Change of lightness value
Change of lightness value by a chromometer

Secondary Outcome Measures

Full Information

First Posted
January 13, 2023
Last Updated
January 24, 2023
Sponsor
Ajou University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05710068
Brief Title
Effects of RF Microneedle on Photoaging Skin
Official Title
RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmentation, Pigmentation Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
split lesion study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy with RF microneedle
Arm Type
Experimental
Arm Description
Half face Oral tranexamic acid combined with triple combination cream with RF microneedle
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Half face Oral tranexamic acid combined with triple combination cream
Intervention Type
Device
Intervention Name(s)
RF Microneedle
Intervention Description
Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month
Intervention Type
Drug
Intervention Name(s)
Combination cream
Intervention Description
5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months
Primary Outcome Measure Information:
Title
Change of modified melasma area severity index score
Description
Change of modified melasma area severity index score
Time Frame
Every 1 month up to 8 months
Title
Change of lightness value
Description
Change of lightness value by a chromometer
Time Frame
Every 1 month up to 8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult more than 19 years old Melasma clinically diagnosed by three dermatologists Exclusion Criteria: Aesthetic medical procedures in three months prior to the study Use of topical depigmenting agents in three months prior to the study Pregnant or lactating
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of RF Microneedle on Photoaging Skin

We'll reach out to this number within 24 hrs