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CompletedNCT05710068Updated Feb 2, 2023

Effects of RF Microneedle on Photoaging Skin

An interventional study of RF Microneedle and Combination cream in Pigmentation and Pigmentation Disorder, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Dec 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
20 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Pigmentation
  • Pigmentation Disorder

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In context

Pigmentation Disorders

44 studies on the registry are indexed under Pigmentation Disorders; 11 are open to participants now.

This study's enrollment of 15 is below the median of 32 across 33 interventional studies indexed under Pigmentation Disorders.

Browse Pigmentation Disorders studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Conventional therapy with RF microneedle

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

    Device: RF Microneedle · Drug: Combination cream

  • Active comparator
    Conventional therapy

    Half face Oral tranexamic acid combined with triple combination cream

    Drug: Combination cream

Interventions

  • DeviceRF Microneedle

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

  • DrugCombination cream

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

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What researchers measure

Primary outcomes

  1. Change of modified melasma area severity index score

    Change of modified melasma area severity index score

    Time frame: Every 1 month up to 8 months

  2. Change of lightness value

    Change of lightness value by a chromometer

    Time frame: Every 1 month up to 8 months

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Study locations

1 site
  • Ajou University Hospital
    Suwon, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05710068
Lead sponsor
Ajou University School of Medicine
Responsible party
Jin Cheol Kim (Principal Investigator, Clinical Fellow, Ajou University School of Medicine) — Principal investigator
First posted
Feb 2, 2023
Start date
Dec 1, 2021
Primary completion
Aug 1, 2022
Completion
Sep 1, 2022
Last update
Feb 2, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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