Effects of RF Microneedle on Photoaging Skin

NCT ID: NCT05710068

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pigmentation Pigmentation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

split lesion study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional therapy with RF microneedle

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

Group Type EXPERIMENTAL

RF Microneedle

Intervention Type DEVICE

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

Combination cream

Intervention Type DRUG

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

Conventional therapy

Half face Oral tranexamic acid combined with triple combination cream

Group Type ACTIVE_COMPARATOR

Combination cream

Intervention Type DRUG

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

Interventions

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RF Microneedle

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

Intervention Type DEVICE

Combination cream

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jin Cheol Kim

Principal Investigator, Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajou University Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 38200171 (View on PubMed)

Other Identifiers

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AJOUIRB-INT-2021-133

Identifier Type: -

Identifier Source: org_study_id

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