Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001238662
Ethics application status
Approved
Date submitted
1/11/2014
Date registered
26/11/2014
Date last updated
26/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Mastic paint in the Treatment of nail disorders (Onycholysis, Onychomycosis, Onychorrhexis)
Scientific title
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).
Secondary ID [1] 285584 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Onycholysis 293414 0
Onychomycosis 293416 0
Onychorrhexis 293417 0
Condition category
Condition code
Skin 293694 293694 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 290533 0
Treatment: Other
Intervention code [2] 290534 0
Treatment: Drugs
Comparator / control treatment
Topically applied glycerin
Dose & Duration of administration: 0.1 ml/ site applied topically 4 times daily by brush, for 1 month.
Control group
Placebo

Outcomes
Primary outcome [1] 293503 0
Cure rates: Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment.
Timepoint [1] 293503 0
1 month for treatment
4 months for followup
Primary outcome [2] 293592 0
Antifungal activity by culture of Nail clippings, and skin scraped from under a nail.
Culture identifies which organism is responsible for the infection.
Sabouraud-chloramphenicol and Sabouraud-chloramphenicol-actidione culture will perform. Species identification will base on microscopic characteristics of the fungus observe.
Timepoint [2] 293592 0
Before and after 1 month of treatment.
Primary outcome [3] 293657 0
Antioxidant effect by measuring serum Trolox (Total antioxidant capacity).
Timepoint [3] 293657 0
Before and after 1 month of treatment.
Secondary outcome [1] 311183 0
follow up for any adverse reaction or side effects
like sensitivity or hypersensitivity to the components of mastic paint.
The follow up by telephone or messenger, or visit.
Timepoint [1] 311183 0
4 months
Secondary outcome [2] 311526 0
Histopathological examination of nails using periodic acid-Schiff (PAS) stains.
Timepoint [2] 311526 0
1 month

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
2/04/2014
Date of last participant enrolment
Anticipated
1/07/2014
Actual
1/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 6447 0
Iraq
State/province [1] 6447 0

Funding & Sponsors
Funding source category [1] 290178 0
Self funded/Unfunded
Name [1] 290178 0
Dr Tagreed Altaei
Country [1] 290178 0
Iraq
Primary sponsor type
University
Name
Hawler Medical University
Address
College of Dentistry/Hawler Medical University
60 meter
Erbil
44001
Kurdistan/Iraq
Country
Iraq
Secondary sponsor category [1] 288888 0
None
Name [1] 288888 0
None
Address [1] 288888 0
None
Country [1] 288888 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52446 0
Dr Tagreed Altaei
Address 52446 0
College of Dentistry/Hawler Medical University
Erbil
60 meter
44001
Kurdistan
Country 52446 0
Iraq
Phone 52446 0
+964 750 4941834
Fax 52446 0
Email 52446 0
[email protected]
Contact person for public queries
Name 52447 0
Tagreed Altaei
Address 52447 0
College of Dentistry/Hawler Medical University
Erbil
60 meter
44001
Kurdistan
Country 52447 0
Iraq
Phone 52447 0
+964 750 4941834
Fax 52447 0
Email 52447 0
[email protected]
Contact person for scientific queries
Name 52448 0
Tagreed Altaei
Address 52448 0
College of Dentistry/Hawler Medical University
Erbil
60 meter
44001
Kurdistan
Country 52448 0
Iraq
Phone 52448 0
+964 750 4941834
Fax 52448 0
Email 52448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.