Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/ACTRN12614001238662
ACTRN12614001238662Active, not recruitingPhase 1

A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, antifungal, anti-inflammatory, and antioxidant activities of mastic paintin the Treatment of nail disorders (Onycholysis, Onychomycosis, Onychorrhexis).

Hawler Medical University0 sites75 target enrollmentStarted: November 26, 2014Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
75
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment
Masking
Blinded (masking used)

Eligibility Criteria

Ages
18 Years to 75 Years (—)
Sex
All

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

Investigators

Similar Trials

Active, not recruiting
Phase 1
A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation TherapyBone Loss in Subjects Undergoing Androgen-Deprivation Therapy (ADT) for Non-metastatic Prostate CancerMedDRA version: 12.0Level: LLTClassification code 10065687Term: Bone loss
EUCTR2009-012076-26-GRAmgen Inc760
Active, not recruiting
Phase 1
A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy
EUCTR2009-012076-26-PLAmgen Inc760
Active, not recruiting
Phase 1
A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation TherapyAndrogen-dependent non-metastatic prostate cancer and therapy-induced bone lossMedDRA version: 17.0Level: PTClassification code 10065687Term: Bone lossSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 17.0Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 100000004864
EUCTR2009-012076-26-SIAmgen Inc769
Active, not recruiting
Phase 1
A Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation TherapyAndrogen-dependent non-metastatic prostate cancer and therapy-induced bone lossMedDRA version: 17.1Level: PTClassification code 10065687Term: Bone lossSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 17.1Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 100000004864
EUCTR2009-012076-26-CZAmgen Inc760
Active, not recruiting
Phase 1
A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation TherapyBone Loss in Subjects Undergoing Androgen-Deprivation Therapy (ADT) for Non-metastatic Prostate CancerMedDRA version: 12.0Level: LLTClassification code 10065687Term: Bone loss
EUCTR2009-012076-26-FRAmgen Inc760