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).

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001238662

Enrollment

Registered

2014-11-26

Start date

2014-04-02

Completion date

2014-07-01

Last updated

2020-01-13

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

Conditions

None listed

Brief 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

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results