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A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment

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ClinicalTrials.gov Identifier: NCT02464826
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.

Condition or disease Intervention/treatment Phase
Onychomycosis Chronic Paronychia Drug: Nailprotex Phase 4

Detailed Description:

Onychomycosis is the common superficial fungal skin infection in general population. According to the previous study, the prevalence of tinea pedis and onychomycosis in general Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected for treatment due to asymptomatic clinical manifestations and low effects in quality of life.

In Thailand, the previous studies reported that the aetiological pathogens of this disorder were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally, Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.

Systemic therapy such as azoles group and terbinafine is recommended for the standard management of tinea capitis. In contrast, a prolonged course may be induce serious side effects. So that topical therapy is the alternative treatment in older patients who are limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant condition. Moreover, none of the standard regimen is recommended.

Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The active ingredient is phenol which is extracted from Olea European leaf. It is able to inhibit the fungal growth. Additionally, this product has been applied for nail care in many European countries over 10 years. The serious side effects have never been reported. Therefore, this study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
Study Start Date : July 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Edit arms
Nailprotex apply to the abnormal nail twice daily
Drug: Nailprotex
Nailprotex apply to the abnormal nail twice daily




Primary Outcome Measures :
  1. The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex® [ Time Frame: 6 months ]
    Patients who were treated by Nailprotex® in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline and after using Nailprotex® 6 months. Then the change in SCIO score was analyzed in percentage and compare mean.


Secondary Outcome Measures :
  1. The side effects of Nailprotex® [ Time Frame: 6 months ]
    The side effects of Nailprotex® was observed in patients from date of first application or first side effects documented progression until the date of end of study, assessed up to 6 months.

  2. Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex® [ Time Frame: 6 months ]
    Patients who were treated by Nailprotex® in this study were evaluated the results of laboratory investigation (KOH examination and fungal culture) at baseline and after using Nailprotex® 6 months. Then mycological cure rate was analyzed in percentage.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female participants was 18 years old or above.
  • Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
  • Participants accept the aim of this project and sign the consent form by themselves.

Exclusion Criteria:

  • Participants have other nail disorders before participate the research.
  • Participants have the history of immunocompromised host.
  • Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464826


Locations
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Thailand
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Charussri - Leeyaphan, MD. Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02464826     History of Changes
Other Study ID Numbers: Efficacynailprotex
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Keywords provided by Mahidol University:
Onychomycosis
Chronic paronychia
Treatment
Additional relevant MeSH terms:
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Onychomycosis
Paronychia
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases