RECRUITINGPhase 3INTERVENTIONAL
Study to Assess Efficacy, Safety and Tolerability of a Nail Patch in Patients With Nail Fragility, Mychosis, 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
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
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
OTHER
Cosmetic patch containing urea applicated daily for 3 months
Daily application of the patch on toes, 3 months treatment
OTHER
Placebo patch application
Daily application of a placebo patch on toes for a 3 months treatment
Locations (1)
Clinica Dermatologica - Policlinico - Università degli Studi di Milano Via Francesco Sforza- Milano
Milan, Italy