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NCT05710068 Clinical Trial

Effects of RF Microneedle on Photoaging Skin

Pigmentation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05710068
Other study ID # AJOUIRB-INT-2021-133
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date September 1, 2022

Study information
Verified date January 2023
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date September 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Ajou University Hospital Suwon

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

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