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Effects of RF Microneedle on Photoaging Skin

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT05710068
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: RF Microneedle
  • Drug: Combination cream
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
split lesion studysplit lesion study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Conventional therapy with RF microneedle

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

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
Active Comparator: Conventional therapy

Half face Oral tranexamic acid combined with triple combination cream

Drug: Combination cream
5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months

Outcome Measures

Primary Outcome Measures

  1. Change of modified melasma area severity index score [Every 1 month up to 8 months]

    Change of modified melasma area severity index score

  2. Change of lightness value [Every 1 month up to 8 months]

    Change of lightness value by a chromometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ajou University Hospital Suwon Korea, Republic of

Sponsors and Collaborators

  • Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin Cheol Kim, Principal Investigator, Clinical Fellow, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT05710068
Other Study ID Numbers:
  • AJOUIRB-INT-2021-133
First Posted:
Feb 2, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pigmentation Disorders

Study Results

No Results Posted as of Feb 2, 2023