Onychomycosis Clinical Trial
Official title:
Effectiveness of Supplementation With Nail Debridement in Ungual Lacquer Treatment in Podiatry Care on Onychomycosis: Pilot Study of Randomized Control Trial
Onychomycosis occurs in more than 50% of all pathologies unguinal, affecting the health and
quality of life of the patient. Although the investigators have a wide therapeutic arsenal,
there is still a disparity when carrying out an effective processing.
Hypothesis/Objectives:
To analyze if the use of the podiatric technique of aggressive unguinal abrasion with
micrometer sports, in combination with topical treatment with amorolfin 5% in hairspray,
significantly increases the effectiveness clinically as well as mycology.
The investigators will analyze the relationship between this intervention and the quality
perception of life related to the health of the nails and the foot.
The investigators will Use results for next validation study in Spanish of the questionnaire
NailQoL, as well as validation and reliability of the index SCIO and cost study-effectiveness
of the processing.
Method:
The investigators will design a randomized control trial. The town will be recruited,
informed prior consent will be obtained from patients of 5 Spanish centers of chiropody, with
sample size of 313 patients. There will be a screening of 4 weeks to select patients with
onychomycosis infections (clinic and mycology both positives); later the patients will be
distributed randomly in 2 groups:
- GROUP AM+AU: Will be administered aggressive unguinal abrasion, weeks 0 (baseline), 12
and 24, followed by standard treatment of amorolfin 5%, two weekly applications during
36 weeks.
- GROUP AM: Will be administered exclusively standard treatment of amorolfin 5%, according
to common format. The duration will be 48 weeks.
n/a
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