Evaluation of Mastic paint in the Treatment of nail disorders (Onycholysis, Onychomycosis, Onychorrhexis)
A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, antifungal, anti-inflammatory, and antioxidant activities of mastic paint in the Treatment of nail disorders (Onycholysis, Onychomycosis, Onychorrhexis).
Hawler Medical University
75 participants
Apr 2, 2014
Interventional
Conditions
Summary
The purpose of this study is to determine the topical treatment is effective for the treatment of nails disorders (Onycholysis, Onychomycosis, Onychorrhexis). A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, antifungal, anti-inflammatory, and antioxidant activities of mastic paint in the Treatment of Onycholysis, Onychomycosis, Onychorrhexis of The nails
Eligibility
Inclusion Criteria6
- 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:
- 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 Criteria5
- 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
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Interventions
Mastic paint Dose: 0.1 ml/site Duration 4 times daily Mode of administration: Topical by brush Method of monitor adherence: follow up the patients each 2 days for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 4 months
Locations(1)
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ACTRN12614001238662