Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis

Stopped early · Not applicable · Has a placebo group

Conditions studied: Onychomycosis of Toenails

In brief

The purpose of this study is to assess the clinical efficacy and safety of the PinPointe Foot Laser device for the treatment of patients with onychomycosis who have been previously treated with oral Terbinafine and failed.

Key facts

Study ID

NCT01920178

Run by

Cambridge Health Alliance

People needed

7

Starts

2013-04-01

Expected to finish

2015-05-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous treatment with at least 90 days of oral Terbinafine and completed the treatment at least 1 year ago
• Able to feel a Semmes-Weinstein monofilament at the tip of each toe
• Must have at least 50% involvement in at least one great toenail
• Must be willing and able to present for one treatment visit and two follow-up visits at 6 months and 12 months following initial treatment to photograph the nails
• Must be willing to apply topical antifungal to the skin surrounding the toes on a daily basis and be willing to spray shoes with an aerosolized antifungal on a weekly basis
• Must have dystrophic toenails which clinically appear to be mycotic
• Age ≥ 18 years and ≤ 70 years
• Willing to comply with study requirements, including regular nail debridement as indicated by the investigator
• Willing to provide informed consent to participate

You may not qualify if…

• Evidence of gangrene or non-palpable dorsalis pedis and posterior tibial pulses
• Capillary refill time greater than 5 seconds
• Patients who are severely immunocompromised (such as in AIDS, renal transplant regimens, immunosuppressed states consequent to malignancy or agents used in rendering oncologic care, or who suffer from end stage renal disease)
• Patients with documented diagnosis of psoriasis or lichen planus
• Actively treating fungal nails with a topical agent during the last 90 days prior to enrollment, including tea tree oil, antifungal nail polish, Penlac, fungoid tincture, or similar over-the-counter antifungal treatments
• Inability to follow treatment regimen or comply with follow-up schedules
• History of malignant melanoma or any forms of skin cancers
• Evidence of acute bacterial infections with or without cellulitis and/or purulence
• Treatment for onychocryptosis during the last 30 days or a history of recurrent onychocryptosis of at least 3 episodes in the last 12 months in which medical care such as resection by a podiatrist/physician, or use of antibiotics was rendered
• Toenail deformity associated with trauma, psoriasis or lichen planus

Where it is running

• Cambridge Health Alliance — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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