Effects of RF Microneedle on Photoaging Skin

RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study

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.

Study Overview

• Status: Completed
• Conditions: Pigmentation Disorder; Pigmentation
• Intervention / Treatment: Device: RF Microneedle; Drug: Combination cream

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional therapy with RF microneedle; Half face Oral tranexamic acid combined with triple combination cream with RF microneedle	Device: RF Microneedle; Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month; Drug: Combination cream; 5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months
ACTIVE_COMPARATOR: Conventional therapy; Half face Oral tranexamic acid combined with triple combination cream	Drug: Combination cream; 5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of modified melasma area severity index score	Change of modified melasma area severity index score	Every 1 month up to 8 months
Change of lightness value	Change of lightness value by a chromometer	Every 1 month up to 8 months

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ACTUAL): August 1, 2022
• Study Completion (ACTUAL): September 1, 2022

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: AJOUIRB-INT-2021-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No