Mycosis, Nail Damage, Nail Psoriasis
Conditions
Keywords
ONICOMYCOSIS, PATCH, UREA, PSORIASIS
Brief 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
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.
Interventions
OTHERCosmetic patch containing urea applicated daily for 3 months
Daily application of the patch on toes, 3 months treatment
OTHERPlacebo patch application
Daily application of a placebo patch on toes for a 3 months treatment
Sponsors
Wooshin Labottach Co., Ltd.
Nextrasearch S.r.l.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
ANONIMIZATION
Intervention model description
6 GROUPS (3 PATOLOGIES ONE EXPERIMENTAL, ONE PLACEBO)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the patch, measuring the size of the nail patology | From enrollment day (visit 1) to the follow-up visit after 4 months | 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 |
Countries
Italy
Contacts
CONTACTAdolfo Gasparetto
CONTACTAndrea Borgatta
Outcome results
None listed