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Efficacy of Laser treatment for Onychomycosis: clinical trial

Efficacy of Photodynamic Therapy in the treatment of Onychomycosis: a randomized, placebo-controlled, double-blind clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-256tk2b
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial with two groups. The sample size was calculated with a 40% effect size as described in the literature, an a significance level of
E02.594.540

Sponsors

Faculdade de Enfermagem da Universidade do Estado do Rio de Janeiro
Lead Sponsor
Universidade do Estado do Rio de Janeiro
Collaborator
Faculdade de Enfermagem da Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Volunteer of both sexes; 18 to 90 years old; with Diabetes Mellitus; with laboratory-confirmed Onychomycosis

Exclusion criteria

Exclusion criteria: Volunteers with foot ulcers, ankle-brachial index below 0.89, Tinea Pedis; fungal skin infections; using corticosteroids; immunosuppressants; chemotherapy and/or antifungals; autoimmune diseases and Human Immunodeficiency Virus; pregnant women

Design outcomes

Primary

MeasureTime frame
It is expected to verify after the intervention the absence of Fungi in the nail plate, evaluated by the method of direct mycological examination of the subungual scraping and culture for Fungi

Secondary

MeasureTime frame
It is expected that after the intervention there will be clinical improvement in the Nail Dystrophy caused by Fungus, verified by physical examination of the nail plate

Countries

Brazil

Contacts

Public ContactEugenio Pérez Júnior

Faculdade de Enfermagem da Universidade do Estado do Rio de Janeiro

eugenioperezjunior@gmail.com+5521981228460

Outcome results

None listed

Source: REBEC (via WHO ICTRP)