NCT05710068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 13, 2023

Last Update Submit

January 24, 2023

Conditions

PigmentationPigmentation Disorder

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Conventional therapy with RF microneedle

EXPERIMENTAL

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

Device: RF MicroneedleDrug: Combination cream

Conventional therapy

ACTIVE COMPARATOR

Half face Oral tranexamic acid combined with triple combination cream

Drug: Combination cream

Interventions

RF MicroneedleDEVICE

Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month

Conventional therapy with RF microneedle
Combination creamDRUG

5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months

Conventional therapyConventional therapy with RF microneedle

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult more than 19 years old
  • Melasma clinically diagnosed by three dermatologists

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (1)

  • Han HJ, Kim JC, Park YJ, Kang HY. Targeting the dermis for melasma maintenance treatment. Sci Rep. 2024 Jan 10;14(1):949. doi: 10.1038/s41598-023-51133-w.

    PMID: 38200171DERIVED

MeSH Terms

Conditions

Pigmentation Disorders

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: split lesion study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Fellow

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 2, 2023

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)