Clinical Trial: Comparison Between Long-pulsed Nd:YAG, Amorolfine and Combination Treatment in Treating Non-dermatophyte Onychomycosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of the Efficacy and Safety Between Long-pulsed Nd:YAG, Amorolfine and Combination of Long-pulsed Nd:YAG and Amorolfine in Treating Non-dermatophyte and Mixed-infection Onychomycosis

Brief Summary: This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis.

Detailed Summary:

Onychomycosis is the most common cause of nail deformities resulting with more than 50% of the patients with abnormal nails. From the institution of dermatology of Thailand, it confirmed that 1.7% of Thai population have onychomycosis. Most of the patients aged between 40-60 years old with female predominated. The common cause of onychomycosis worldwide is dermatophyte group, found in more than 50% of the patients. However, in Thailand, the study showed that 51.6% of patients with onychomycosis were infected by non-dermatophyte group especially Neoscytalidium spp.

The goal standard treatment for onychomycosis was oral anti-fungal drugs such as Fluconazole, Itraconazole and Terbinafine. But many patients were limited to the oral medications due to drug interaction between other CYP P2C9 inhibition such as statins, causing the risk of rhabdomyolysis and hepatotoxicity. Even though these medications are effective against dermatophytes. The non-dermatophytes which were the leading pathogens for onychomycosis in Thailand tends to be resistant to the oral medications. Therefore topical and other modalities have become an important role for treating those non-dermatophytes onychomycosis such as topical anti-fungals, topical urea cream and laser treatment. So far, no standard treatment has been made in order to treat the non-dermatophyte onychomycosis causing problems to both patients and physicians in Thailand.

Amorolfine is a morpholine derivative used in topical anti-fungal that inhibits the biosynthesis of the fungal cell membrane and showed fungicidal activities. From the previous study, amorolfine is an effective topical treatment against non-dermatophyte onychomycosis with 52-55% mycological cure rate and the clinical cure rate varied from 12.7%-54% depending on the studies. The side effects were minimal and the application
Sponsor: Mahidol University

Current Primary Outcome: Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 6 months after treatment ]

Mycological cure defined as negative Mycological culture


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 6 months after treatment ]
  • pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  • pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  • pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  • pain score in participants who received long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 4 months after treatment ]
  • Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 1 month after treatment ]
  • Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 2 months after treatment ]
  • Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 3 months after treatment ]
  • Depth of nail involvement of onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment [ Time Frame: 6 months after treatment ]


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: October 13, 2015
Date Started: August 2016
Date Completion: April 2017
Last Updated: August 26, 2016
Last Verified: June 2016