NCT01920178 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Arrese JE, Piérard GE
Treatment failures and relapses in onychomycosis: a stubborn clinical problem. Dermatology. 2003;207(3):255-60. Review.
Elewski BE, Scher RK, Aly R, Daniel R 3rd, Jones HE, Odom RB, Zaias N, Jacko ML
Double-blind, randomized comparison of itraconazole capsules vs. placebo in the treatment of toenail onychomycosis. Cutis. 1997 Apr;59(4):217-20.
Gupta AK, Fleckman P, Baran R
Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000 Oct;43(4 Suppl):S70-80.
Haneke E, Abeck D, Ring J
Safety and efficacy of intermittent therapy with itraconazole in finger- and toenail onychomycosis: a multicentre trial. Mycoses. 1998 Dec;41(11-12):521-7.
Pollak R, Billstein SA
Efficacy of terbinafine for toenail onychomycosis. A multicenter trial of various treatment durations. J Am Podiatr Med Assoc. 2001 Mar;91(3):127-31.
Potter LP, Mathias SD, Raut M, Kianifard F, Landsman A, Tavakkol A
The impact of aggressive debridement used as an adjunct therapy with terbinafine on perceptions of patients undergoing treatment for toenail onychomycosis. J Dermatolog Treat. 2007;18(1):46-52.
Scher RK, Tavakkol A, Sigurgeirsson B, Hay RJ, Joseph WS, Tosti A, Fleckman P, Ghannoum M, Armstrong DG, Markinson BC, Elewski BE
Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44. Epub 2007 Feb 16. Review.

A Placebo Controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of PinPointe FootLaser in Patients Who Have Failed Oral Terbinafine Treatment for Onychomycosis

Details for clinical trial NCT01920178

Clinical trial NCT01920178 - References