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Evaluation of Mastic paint in the Treatment of nail disorders (Onycholysis, Onychomycosis, Onychorrhexis)

Phase 1
Active, not recruiting
Conditions
Onycholysis
Onychomycosis
Onychorrhexis
Skin - Dermatological conditions
Registration Number
ACTRN12614001238662
Lead Sponsor
Hawler Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
75
Inclusion Criteria

*Male or female, 18 to 75 years of age, inclusive
Diagnosed with Onycholysis, onychomycosis, or Onychorrhexis of the nails
*At least one target which has:
25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate)
*At least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement
*Nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm

Exclusion Criteria

*Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
*Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
*In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
*History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
*Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail, which could interfere with study evaluations

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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