PsoriasisNCT02955576
Microneedle Patch for Psoriatic Plaques
A study testing Microneedle HA patch and Patch in people with Psoriasis and Administration, Topical, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Psoriasis, Administration, Topical
- What is being tested?
- Microneedle HA patch and Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Nov 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: older than 19
- A patient with psoriasis
- A patient with symmetrical psoriatic lesions
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Who cannot join
- Age: lower than 20
- A pregnant or lactating patient
- A patient who cannot understand the study or who does not sign the informed consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Jung Min Bae, MD, 82-31-249-8209, jminbae@gmail.com
About this study
Official title: Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.
Read the detailed description
As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.
A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.
- Conditions
- Psoriasis, Administration, Topical
- Being tested
- Microneedle HA patch, Patch, Control
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle HA patchDevice
The microneedle HA patch were made of hyaluronic acid with microneedles which can enhance the drug permeation. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.
Microneedle HA patch (Therapass®, RMD-6.5A) was prepared at Raphas Co., Ltd. (Cheonan, South Korea).
Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
PatchDevice
The patch were made of hyaluronic acid with no microneedles to rule out the occlusion effect of microneedle HA patch. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches.
Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
The hyaluronic acid patch was prepared at Raphas Co., Ltd. (Cheonan, South Korea) for this clinical trial, not for sale.
ControlOther
All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Receives: Other: Control |
| Patch group | Active comparator | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. Receives: Device: Patch |
| Microneedle patch group | Experimental | All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. Receives: Device: Microneedle HA patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of psoriasis
The severity of psoriasis will be graded with modified PASI score, and the improvement will be assessed as % from baseline by using a computer program.
Measured: Baseline, 1 week, 2 weeks
Secondary outcomes (1)
The adverse effects of microneedle patch
It will be assessed by patient-report.
Measured: Baseline, 1 week, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionNov 2017 (estimated)
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 PsoriasisStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Bae, The Catholic University of Korea
- Investigators
- Jung Min Bae, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955576
- Sponsor's protocol ID
- VC16DISI0128
- Status last verified
- Nov 2016
- First submitted
- 2 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ju HJ, Kim JY, Jeong DH, Lee MS, Kim GM, Bae JM, Lee JH. Additional Use of Hyaluronic Acid-Based Dissolving Microneedle Patches to Treat Psoriatic Plaques: A Randomized Controlled Trial. Ann Dermatol. 2025 Apr;37(2):105-113. doi: 10.5021/ad.24.024.
PubMed 40165568
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT02955576
- Acronym / sponsor ID
- VC16DISI0128
- Conditions
- Psoriasis, Administration, Topical
- Keywords
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 4 Nov 2016 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of microneedle patch on the psoriatic plaques.
Detailed description
As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.
A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ControlAll lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. |
| Patch group | Active comparator | Device: PatchAll lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. |
| Microneedle patch group | Experimental | Device: Microneedle HA patchAll lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: older than 19
- A patient with psoriasis
- A patient with symmetrical psoriatic lesions
- A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Key exclusion criteria (3 listed)
- Age: lower than 20
- A pregnant or lactating patient
- A patient who cannot understand the study or who does not sign the informed consent
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 |
|---|---|---|
| Microneedle HA patchThe microneedle HA patch were made of hyaluronic acid with microneedles which can enhance the drug permeation. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches. Microneedle HA patch (Therapass®, RMD-6.5A) was prepared at Raphas Co., Ltd. (Cheonan, South Korea). Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied. | Device | Microneedle patch group |
| PatchThe patch were made of hyaluronic acid with no microneedles to rule out the occlusion effect of microneedle HA patch. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied. The hyaluronic acid patch was prepared at Raphas Co., Ltd. (Cheonan, South Korea) for this clinical trial, not for sale. | Device | Patch group |
| ControlAll lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only. Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied. | Other | Control group |
Primary outcome
The improvement of psoriasis
Time frame: Baseline, 1 week, 2 weeks
The severity of psoriasis will be graded with modified PASI score, and the improvement will be assessed as % from baseline by using a computer program.
1 secondary outcome
The adverse effects of microneedle patch
Time frame: Baseline, 1 week, 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 40165568Ju HJ, Kim JY, Jeong DH, Lee MS, Kim GM, Bae JM, Lee JH. Additional Use of Hyaluronic Acid-Based Dissolving Microneedle Patches to Treat Psoriatic Plaques: A Randomized Controlled Trial. Ann Dermatol. 2025 Apr;37(2):105-113. doi: 10.5021/ad.24.024.
- Individual participant dataSharing planned: Undecided
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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.
Jung Min Bae, MD, PhD study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle HA patch and Patch in people with Psoriasis and Administration, Topical, run by The Catholic University of Korea 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 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Min Bae, MD, PhD (82-31-249-8209, jminbae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of psoriasis (time frame: Baseline, 1 week, 2 weeks). 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 NCT02955576, 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 15 Nov 2016.