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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 31, 2017

Primary Completion Date

October 31, 2019

Study Completion Date

December 31, 2019

Conditions
Onychomycosis of Toenail
Interventions
DRUG

P-3058 (terbinafine hydrochloride 10%)

Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

DRUG

Vehicle of P-3058

Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.

Trial Locations (26)

10025

Polichem Investigation site no 1, New York

32204

Polichem Investigation Site no 23, Jacksonville

33012

Polichem Investigation Site no 2, Hialeah

33176

Polichem Investigation Site no 22, Miami

40202

Polichem Investigation Site no 52, Louisville

45249

Polichem Investigation Site no 44, Cincinnati

71071

Polichem Investigation Site no 40, Norman

73103

Polichem Investigation Site no 14, Oklahoma City

75234

Polichem Investigation Site no 11, Dallas

75246

Polichem Investigation Site no 43, Dallas

76107

Polichem Investigation Site no 6, Fort Worth

77055

Polichem Investigation Site no 12, Houston

77081

Polichem Investigation Site no 4, Houston

78229

Polichem Investigation Site no 53, San Antonio

78249

Polichem Investigation Site no 54, San Antonio

78660

Polichem Investigation Site no 42, Pflugerville

78731

Polichem Investigation Site no 10, Austin

91606

Polichem Investigation Site no 45, North Hollywood

92056

Polichem Investigation Site no 5, Oceanside

92123

Polichem Investigation Site no 39, San Diego

03801

Polichem Investigation Site no 41, Portsmouth

T2G 1B1

Polichem Investigation site no 3, Calgary

T5K 1X3

Polichem Investigation Site no 8, Edmonton

L5H 1G9

Polichem Investigation Site no 13, Mississauga

L4C 9M7

Polichem Investigation Site no 9, Richmond Hill

M9W 4L6

Polichem Investigation Site no 7, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Almirall, S.A.

INDUSTRY

lead

Polichem S.A.

INDUSTRY

NCT03094468 - Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis | Biotech Hunter | Biotech Hunter