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OpenTrials
Completed

NCT Number: NCT05710068

Effects of RF Microneedle on Photoaging Skin

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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Key information

Conditions

Pigmentation Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorder Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RF Microneedle

Device

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

Combination cream

Drug

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

Primary outcomes

  1. Change of modified melasma area severity index score

    Time frame: Every 1 month up to 8 months

    Change of modified melasma area severity index score

  2. Change of lightness value

    Time frame: Every 1 month up to 8 months

    Change of lightness value by a chromometer

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2023
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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