PigmentationNCT05710068
Effects of RF Microneedle on Photoaging Skin
A study testing RF Microneedle and Combination cream in people with Pigmentation and Pigmentation Disorder, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pigmentation, Pigmentation Disorder
- What is being tested?
- RF Microneedle and Combination cream
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult more than 19 years old
- Melasma clinically diagnosed by three dermatologists
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
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.
- Conditions
- Pigmentation, Pigmentation Disorder
- Being tested
- RF Microneedle, Combination cream
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF MicroneedleDevice
Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month
Combination creamDrug
5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy with RF microneedle | Experimental | Half face Oral tranexamic acid combined with triple combination cream with RF microneedle Receives: Device: RF Microneedle; Drug: Combination cream |
| Conventional therapy | Active comparator | Half face Oral tranexamic acid combined with triple combination cream Receives: Drug: Combination cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of modified melasma area severity index score
Change of modified melasma area severity index score
Measured: Every 1 month up to 8 months
Change of lightness value
Change of lightness value by a chromometer
Measured: Every 1 month up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split lesion study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Cheol Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710068
- Sponsor's protocol ID
- AJOUIRB-INT-2021-133
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38200171
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study
- ClinicalTrials.gov ID
- NCT05710068
- Acronym / sponsor ID
- AJOUIRB-INT-2021-133
- Conditions
- Pigmentation, Pigmentation Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- split lesion study
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy with RF microneedle | Experimental | Device: RF Microneedle, Drug: Combination creamHalf face Oral tranexamic acid combined with triple combination cream with RF microneedle |
| Conventional therapy | Active comparator | Drug: Combination creamHalf face Oral tranexamic acid combined with triple combination cream |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult more than 19 years old
- Melasma clinically diagnosed by three dermatologists
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF MicroneedlePulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month | Device | Conventional therapy with RF microneedle |
| Combination cream5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months | Drug | Conventional therapy, Conventional therapy with RF microneedle |
Primary outcome
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
Change of lightness value
Time frame: Every 1 month up to 8 months
Change of lightness value by a chromometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Derived from this study: PubMed 38200171Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Microneedle and Combination cream in people with Pigmentation and Pigmentation Disorder, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of modified melasma area severity index score (time frame: Every 1 month up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.