Nail PsoriasisPhase 3NCT07029516
Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis
A Phase 3 study testing Cosmetic patch containing urea applicated daily for 3 months in people with Nail Psoriasis and Nail Damage, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
Trial summary
A randomized, double blind, placebo-controlled, unicenter, parallel group study to assess the efficacy, safety and tolerability of a multi-funtion toe nail patch in patients affected by nail fragility, nail mychosis and psoriasis 72 patients in 6 subgroups Treatment duration 3 months + 1 month follow-up Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nail Psoriasis, Nail Damage, Mycosis
- What is being tested?
- Cosmetic patch containing urea applicated daily for 3 months
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2026to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older Fragility Nails Distal Subungual Onychomycosis Nail Psoriasis affecting ≤75% of the nail bed according to a photographic documentation and to a subjective evaluation by the Investigator.
Who cannot join
- Patients that have proximal subungual onychomycosis, if their distal subungual onychomycosis is extended into the proximal portion of the nail or if it affects >75% of the nail.
- Patients with conditions known to cause abnormal nail appearance, immunosuppression and signs of severe peripheral circulatory insufficiency
- Patients who had used topical antifungal, anti-psoriasis nail treatment within one month or systemic antifungal treatment within three months.
- Patients who have participated in another clinical nail study during the previous three months
- Patients who have a known allergy to any of the study treatments.
- Patients with unrelated nail disorders: onychomycosis, nail psoriasis, genetically induced onychodystrophy.
- Patients with other nail disorders, active or severe psoriasis elsewhere, other autoimmune or inflammatory diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano
Milan, 20122
Paolo Bortoluzzi, Phd, +393494182187, paolo.bortoluzzi@policninico.mi.it
Paolo Bortoluzzi, Phd
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Unicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of a Multi-funtion Toe Nail Patch in Patients Affected by Nail Fragility, Nail Mychosis and Psoriasis
A randomized, double blind, placebo-controlled, unicenter, parallel group study to assess the efficacy, safety and tolerability of a multi-funtion toe nail patch in patients affected by nail fragility, nail mychosis and psoriasis 72 patients in 6 subgroups Treatment duration 3 months + 1 month follow-up
Read the detailed description
A randomized, double blind, placebo-controlled, mono center, parallel group study.
72 Eligible patients will receive Hydrogel Nail Patch every day for three months, in the evening. All the patients will be characterized according to the percentage of target nail involvement (defined as either 50% or 51-75).
Patients applied their allocated treatment to the surface of all affected nails, in particular Hydrogel Nail Patch or Placebo will be applied topically in the evening at bedtime and taken away in the morning, every day for 12 (twelve)weeks. The subjects will receive a visit by the Clinical Investigator after 4 weeks from the end of treatments.
A single affected nail with Fragility nail or onychomycosis or nail psoriasis will be identified as the target nail for all assessments. Target nails had to fulfil the study's inclusion and exclusion criteria and the presence of nail pathology confirmed by Score Index test, photographic documentation, physician judgement. Patients will attend visits at screening(V0), baseline (V1), and at weeks 3(V2), 6(V3), 9(V4) and 12(V5).
The Multi-Function Toe Nail Patch and the Placebo will be applied topically on the big toe affected by nail pathology, according to their characteristics.
- Conditions
- Nail Psoriasis, Nail Damage, Mycosis
- Being tested
- Cosmetic patch containing urea applicated daily for 3 months, Placebo patch application
- Keywords
- ONICOMYCOSIS, PATCH, UREA, PSORIASIS
- Medical subject headings
- Mycoses, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic patch containing urea applicated daily for 3 monthsOther
Daily application of the patch on toes, 3 months treatment
Placebo patch applicationOther
Daily application of a placebo patch on toes for a 3 months treatment
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL COSMETIC | Experimental | APPLICATION OF THE EXPERIMENTAL PATCH WITH COSMETIC Receives: Other: Cosmetic patch containing urea applicated daily for 3 months |
| Placebo | Placebo comparator | Application of the Placebo patch Receives: Other: Placebo patch application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation, based on adverse events numeber of the Multi-Function Hydrogel Nail Patch safety in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis
Checking of any adverse event during the treatment, and at monthly visits
Measured: From the enrollment day (visit 1) to the follow-up visit after 4 months
Secondary outcomes (1)
Efficacy of the patch, measuring the size of the nail patology
Evaluation of the Multi-Function Hydrogel Nail Patch medical device in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis Visual improvement in clear nail at least of 50% considering the number of patients with 50% nail clearing and the rate at which the nail clearing takes place in the two treatment groups
Measured: From enrollment day (visit 1) to the follow-up visit after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startFeb 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 GROUPS (3 PATOLOGIES ONE EXPERIMENTAL, ONE PLACEBO)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wooshin Labottach Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029516
- Sponsor's protocol ID
- 2025/AFCV/WOOSHIN/MFP/PL
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Unicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of a Multi-funtion Toe Nail Patch in Patients Affected by Nail Fragility, Nail Mychosis and Psoriasis
- ClinicalTrials.gov ID
- NCT07029516
- Acronym / sponsor ID
- 2025/AFCV/WOOSHIN/MFP/PL
- Conditions
- Nail Psoriasis, Nail Damage, Mycosis
- Keywords
- ONICOMYCOSIS, PATCH, UREA, PSORIASIS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wooshin Labottach Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- Feb 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jun 2025 (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.
A randomized, double blind, placebo-controlled, unicenter, parallel group study to assess the efficacy, safety and tolerability of a multi-funtion toe nail patch in patients affected by nail fragility, nail mychosis and psoriasis 72 patients in 6 subgroups Treatment duration 3 months + 1 month follow-up
Detailed description
A randomized, double blind, placebo-controlled, mono center, parallel group study.
72 Eligible patients will receive Hydrogel Nail Patch every day for three months, in the evening. All the patients will be characterized according to the percentage of target nail involvement (defined as either 50% or 51-75).
Patients applied their allocated treatment to the surface of all affected nails, in particular Hydrogel Nail Patch or Placebo will be applied topically in the evening at bedtime and taken away in the morning, every day for 12 (twelve)weeks. The subjects will receive a visit by the Clinical Investigator after 4 weeks from the end of treatments.
A single affected nail with Fragility nail or onychomycosis or nail psoriasis will be identified as the target nail for all assessments. Target nails had to fulfil the study's inclusion and exclusion criteria and the presence of nail pathology confirmed by Score Index test, photographic documentation, physician judgement. Patients will attend visits at screening(V0), baseline (V1), and at weeks 3(V2), 6(V3), 9(V4) and 12(V5).
The Multi-Function Toe Nail Patch and the Placebo will be applied topically on the big toe affected by nail pathology, according to their characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 6 GROUPS (3 PATOLOGIES ONE EXPERIMENTAL, ONE PLACEBO)
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL COSMETIC | Experimental | Other: Cosmetic patch containing urea applicated daily for 3 monthsAPPLICATION OF THE EXPERIMENTAL PATCH WITH COSMETIC |
| Placebo | Placebo comparator | Other: Placebo patch applicationApplication of the Placebo patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 years or older Fragility Nails Distal Subungual Onychomycosis Nail Psoriasis affecting ≤75% of the nail bed according to a photographic documentation and to a subjective evaluation by the Investigator.
Key exclusion criteria (7 listed)
- Patients that have proximal subungual onychomycosis, if their distal subungual onychomycosis is extended into the proximal portion of the nail or if it affects >75% of the nail.
- Patients with conditions known to cause abnormal nail appearance, immunosuppression and signs of severe peripheral circulatory insufficiency
- Patients who had used topical antifungal, anti-psoriasis nail treatment within one month or systemic antifungal treatment within three months.
- Patients who have participated in another clinical nail study during the previous three months
- Patients who have a known allergy to any of the study treatments.
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 |
|---|---|---|
| Cosmetic patch containing urea applicated daily for 3 monthsDaily application of the patch on toes, 3 months treatment | Other | EXPERIMENTAL COSMETIC |
| Placebo patch applicationDaily application of a placebo patch on toes for a 3 months treatment | Other | Placebo |
Primary outcome
Evaluation, based on adverse events numeber of the Multi-Function Hydrogel Nail Patch safety in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis
Time frame: From the enrollment day (visit 1) to the follow-up visit after 4 months
Checking of any adverse event during the treatment, and at monthly visits
1 secondary outcome
Efficacy of the patch, measuring the size of the nail patology
Time frame: From enrollment day (visit 1) to the follow-up visit after 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cosmetic patch containing urea applicated daily for 3 months in people with Nail Psoriasis and Nail Damage, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adolfo Gasparetto (+393356641965, adolfogasparetto@nextrasearch.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation, based on adverse events numeber of the Multi-Function Hydrogel Nail Patch safety in adult humans affected by Fragility Nails, Onychomycosis and Nail Psoriasis (time frame: From the enrollment day (visit 1) to the follow-up visit after 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.