Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, Psoriasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWooshin Labottach Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cosmetic patch containing urea applicated daily for 3 months
Other interventionDaily application of the patch on toes, 3 months treatment
Placebo patch application
Other interventionDaily application of a placebo patch on toes for a 3 months treatment
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: EXPERIMENTAL COSMETICExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From the enrollment day (visit 1) to the follow-up visit after 4 monthsSecondary 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
Time frame
From enrollment day (visit 1) to the follow-up visit after 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wooshin Labottach Co., Ltd.
Lead sponsor
Nextrasearch S.r.l.s.
Collaborator
Source ClinicalTrials.gov