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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001238662
• Date of registration: 26/11/2014
• Prospective Registration: No
• Primary sponsor: Hawler Medical University
• 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).
• Date of first enrolment: 02/04/2014
• Target sample size: 75
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12614001238662.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Iraq

Contacts

• Name: Dr Tagreed Altaei

• Name: Dr Tagreed Altaei

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Onycholysis;Onychomycosis;Onychorrhexis;
Onycholysis
Onychomycosis
Onychorrhexis

Skin - Dermatological conditions

Intervention(s)

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

Primary Outcome(s)

Antioxidant effect by measuring serum Trolox (Total antioxidant capacity).[Before and after 1 month of treatment.]

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.

[1 month for treatment
4 months for followup]

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.[Before and after 1 month of treatment.]

Secondary Outcome(s)

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.[4 months]

Histopathological examination of nails using periodic acid-Schiff (PAS) stains.[1 month]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Dr Tagreed Altaei