Nail Fungus

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Nail Fungus

General Purpose:

In basic terms, nail fungus refers to a fungal infection in one or more of the fingernails or toenails. It can start out as a white or yellow spot and then lead to thickening and discoloration of the nail and nail bed as it spreads. This can cause both pain and embarrassment for those who are affected.

Unfortunately, nail fungus can often be difficult to treat effectively, and it can often recur following successful treatment. Although various yeasts and molds can lead to the development of a fungal nail infection, the most often culprit is a fungi from the dermatophyte group.

Older individuals are at a greater risk for fungal infections in their nails, due to decreased blood circulation, cumulative lifetime exposure to fungi, and age-related decline in the growth of nails (which makes them more susceptible to infections). Apart from age, men are more likely to be affected than women.

Furthermore, moisture and humidity promote the growth of fungus, therefore walking barefoot in bathrooms and locker rooms, working in humid environments, and wearing socks that do not offer adequate ventilation can also increase the risk of fungal infections. Additionally, diabetes, psoriasis and certain immune diseases can also increase an individual’s risk of developing a fungal nail infection.

Fortunately, research is ongoing to determine more effective methods of preventing and treating fungal nail infections, as well as researching the problem from a cosmetic aspect in order to improve the appearance of affected fingers and toes.

What Will Nail Fungus Clinical Trials Be Like?

The types of procedures used in nail fungus clinical trials will ultimately depend on the specific nature of the study, the type of fungi being studied, and the specific aspect(s) of the associated symptoms. Provided below is a list of common procedures, tests, and assessments that may be incorporated into fungal skin infection clinical trials:

  • Detailed physical examination
  • Nail biopsy for microscopic analysis
  • Blood tests
  • Use of lotions, creams, oral medications, or laser light therapy
  • Photography of the fingernails

Typical Nail Fungus Clinical Trial Protocol:

Specific examples of clinical trials for nail fungus might include the following:

  • A clinical trial to determine if a topical anti-fungal cream, applied once a day for four weeks to the affected nail(s) is effective and safe at treating fungal nail infections in diabetic men.
  • A randomized clinical trial in which a standard oral antifungal therapy plus a new topical antifungal medication is collectively more effective at treating severe fungal nail infections when compared to standard oral antifungal therapy plus a placebo topical medication.
  • A study to determine if laser light therapy is a safe and effective means of treating fungal nail infections. In such a study, patients would be randomly assigned to receive either treatment with the laser light or a “placebo” treatment during which laser light therapy is simulated but not actively delivered.  

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second clinical trial example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the third study example above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including the type of fungal nail infection you have. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • The location of your infection (i.e., which nails) and the type of fungal infection you have (if known)
  • Your prior and current diagnoses of any other health conditions or diseases.
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “nail fungus treatment,” “nail fungus prevention,” “nail fungus adolescent,” “nail fungus hygiene,” “nail fungus diabetes,” “nail fungus elderly,” “nail fungus age,” “nail fungus medication,” and “nail fungus complications.”

Current Search Term:

“Nail Fungus”

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Clinical Trial of Topical ABL01 Treatment of Onychomycosis

Condition:   Onychomycosis of Toenail
Interventions:   Device: ABL01;   Device: Placebo
Sponsor:   Abbell AB
Not yet recruiting - verified May 2017

Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis

Condition:   Onychomycosis of Toenail
Interventions:   Drug: P-3058 (terbinafine hydrochloride 10%);   Drug: Vehicle of P-3058
Sponsors:   Polichem S.A.;   Almirall, S.A.
Not yet recruiting - verified March 2017

Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail)

Conditions:   Onychomycosis Due to Trichophyton Rubrum;   Onychomycosis Due to Trichophyton Mentagrophytes
Intervention:   Device: RenewalNail™ Plasma Treatment System
Sponsors:   DeviceFarm, Inc.;   Symbio, LLC;   Center for Dermatology Clinical Research, Inc.
Recruiting - verified March 2017

Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

Condition:   Onychomycosis of Toenail
Interventions:   Procedure: Methylene blue-mediated photodynamic therapy;   Drug: Amorolfine 5% Nail Lacquer
Sponsors:   Chulalongkorn University;   King Chulalongkorn Memorial Hospital
Not yet recruiting - verified February 2017

Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

Condition:   Onychomycosis
Interventions:   Device: Nailner 2 in 1;   Drug: Ciclopirox 8%
Sponsors:   MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA;   Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
Not yet recruiting - verified March 2017

Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

Condition:   Onychomycosis
Interventions:   Drug: NVXT topical;   Drug: Placebo (Vehicle) Topical
Sponsor:   Taro Pharmaceuticals USA
Active, not recruiting - verified May 2017

Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Condition:   Distal Subungual Onychomycosis
Interventions:   Drug: MOB015B;   Drug: Ciclopirox 80 mg/g
Sponsor:   Moberg Pharma AB
Recruiting - verified October 2016

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

Condition:   Onychomycosis
Intervention:   Drug: Efinaconazole
Sponsor:   Valeant Pharmaceuticals International, Inc.
Recruiting - verified April 2017

Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis

Condition:   Onychomycosis
Interventions:   Device: MOE Plasma Delivery System A;   Device: MOE Plasma Delivery System B
Sponsor:   Moe Medical Devices
Recruiting - verified May 2016

The Efficacy of CELEXT07 in the Treatment of Toenail Onychomycosis

Condition:   Onychomycosis
Interventions:   Drug: CELEXT07;   Drug: Penlac;   Other: vehicle solution
Sponsor:   9305-9954 Quebec Inc
Recruiting - verified April 2017

A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis

Condition:   Onychomycosis
Intervention:   Device: Erchonia LUNULA
Sponsor:   Erchonia Corporation
Completed - verified August 2016

Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis

Condition:   Toenail Onychomycosis
Intervention:   Procedure: Aminolevulinic Acid (ALA)
Sponsors:   University of Alabama at Birmingham;   DUSA Pharmaceuticals, Inc.
Recruiting - verified January 2017

Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish

Condition:   Onychomycosis of Toenail
Interventions:   Drug: Efinaconazole 10% (Jublia);   Other: Application of nail polish
Sponsor:   University of Alabama at Birmingham
Active, not recruiting - verified April 2017

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

Condition:   Non-dermatophyte Onychomycosis
Interventions:   Device: 1,064nm Long-pulsed Nd:YAG;   Drug: Amorolfine
Sponsor:   Mahidol University
Recruiting - verified June 2016

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

Condition:   Onychomycosis
Interventions:   Drug: P-3058 10%;   Drug: vehicle of P-3058 10%;   Drug: amorolfine 5%
Sponsor:   Polichem S.A.
Active, not recruiting - verified May 2017

Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Condition:   Onychomycosis
Intervention:   Drug: P-3058
Sponsor:   Polichem S.A.
Active, not recruiting - verified May 2017

Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis

Condition:   Onychomycosis of Toenails
Intervention:   Device: A Fungal Nail Treatment
Sponsors:   Reckitt Benckiser Healthcare (UK) Limited;   Intertek
Completed - verified November 2015

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

Conditions:   Onychomycosis;   Chronic Paronychia
Intervention:   Drug: Nailprotex
Sponsor:   Mahidol University
Completed - verified June 2016

Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.

Condition:   Onychomycosis
Intervention:   Drug: PD P 506 A
Sponsor:   photonamic GmbH & Co. KG
Active, not recruiting - verified December 2016

Laser Treatment for Onychomycosis in Diabetes

Conditions:   Diabetes Mellitus, Type 2;   Onychomycosis
Interventions:   Device: Laser Treatment YAG laser;   Drug: Standard Treatment (control group) terbinafine hydrochloride tablets
Sponsors:   BCDiabetes.Ca;   BritaMed, Inc.
Not yet recruiting - verified February 2017

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Condition:   Onychomycosis
Interventions:   Drug: ME1111 Solution, Low strength;   Drug: ME1111 Solution, High strength;   Drug: Matching Vehicle Solution
Sponsor:   Meiji Seika Pharma Co., Ltd.
Completed - verified March 2017

Pulsed Dye Laser Treatment of Onychomycosis

Condition:   Onychomycosis
Intervention:   Device: Pulsed Dye Laser for the treatment of nail fungus
Sponsor:   Thomas Jefferson University
Completed - verified August 2016

1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Condition:   Fungal Nail Infection
Intervention:   Device: Laser treatment
Sponsors:   University of California, Irvine;   Beckman Laser Institute University of California Irvine
Completed - verified February 2017

A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

Condition:   Onychomycosis
Interventions:   Drug: SCH 56592;   Drug: SCH 56592;   Drug: SCH 56592;   Drug: SCH 56592;   Drug: Terbinafine;   Drug: Placebo
Sponsor:   Merck Sharp & Dohme Corp.
Completed - verified March 2017

Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

Condition:   Onychomycosis
Interventions:   Drug: Itraconazole 100mg capsules;   Drug: Itraconazole 200mg tablets;   Drug: Placebo tablets
Sponsors:   Stiefel, a GSK Company;   GlaxoSmithKline
Completed - verified December 2016

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