The FDA approved Valeant Pharmaceuticals’ Luzu (luliconazole) Cream 1% in November 2013 for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients age 18 years and older.
Luliconazole is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a 1-week, once-daily treatment regimen — all other approved treatments require 2 weeks of treatment. Interdigital tinea pedis is approved with a 2-week, once-daily treatment.
Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.1
When treating interdigital tinea pedis, a thin layer of luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks. When treating tinea cruris or tinea corporis, luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week.1
Athlete’s foot between the toes is caused by a group of fungi called dermatophytes. Individuals can get the fungi by walking barefoot, wearing shoes that do not allow an individual’s feet to “breathe” or by touching the toes or feet of an individual who has it. Men are more prone than women to get athlete’s foot between the toes, and it also tends to affect individuals with a compromised immune system. Symptoms include itching, redness, peeling and discomfort.
Physicians can help patients prevent recurrence of athlete’s foot by educating them on the following tips from the American Academy of Dermatology and Mayo Clinic:
• Wash feet daily with soap and water and dry them well, especially between the toes
• Do not walk barefoot in public areas — wear flip-flops, sandals or water shoes instead
• When at home, take shoes off to let feet air out
• Avoid wearing closed shoes (especially vinyl or rubber ones) that make feet hot and sweaty — particularly during the summer
• Change socks regularly. If feet sweat often, change socks each time they get wet
• Do not borrow or share shoes
• Wear different shoes throughout the week to let shoes dry out
The FDA approved luliconazole based on positive results from 3 pivotal trials evaluating the safety and efficacy of luliconazole in 679 patients with either tinea pedis or tinea cruris.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trials that evaluated the safety and efficacy of luliconazole for the treatment of athlete’s foot and jock itch caused by T rubrum and E floccosum.
Phase III Interdigital Tinea Pedis Clinical Data
Luzu [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014.1
Study Objective
To assess the safety and efficacy of luliconazole to treatment of interdigital tinea pedis.
Method
The 2 randomized, double-blind, vehicle-controlled, multicenter, Phase III pivotal trials included patients with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Patients were randomized to receive luliconazole or vehicle. Patients applied either luliconazole or vehicle cream to forefeet including all the interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days. Signs and symptoms of tinea pedis (erythema, scaling and pruritus), potassium hydroxide (KOH) and dermatophyte culture were assessed at baseline, end of treatment (day 14), 2 and 4 weeks post-treatment.
Population
Studies included 423 patients. Study 1 included 106 patients in the luliconazole group and 103 patients in the vehicle group. Study 2 included 214 patients, with 107 patients each in the luliconazole and vehicle groups. The mean age of the study population was 41 years, 82% were male, 53% were Caucasian and 40% were Black or African American.
Primary Endpoint
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 4 weeks post-treatment.
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).
Results
At 4 weeks post-treatment in study 1, the researchers found that 26% of patients treated with luliconazole were cleared compared to 2% of patients treated with vehicle. In study 2, 14% of patients treated with luliconazole were cleared compared to 3% of patients treated with vehicle. Furthermore, luliconazole demonstrated greater efficacy results in secondary endpoints. In study 1, effective treatment, clinical cure and mycological cure were achieved by 48%, 29% and 62%, respectively, of patients in the luliconazole group versus 10%, 8% and 18%, respectively, of patients in the vehicle group. In study 2, effective treatment, clinical cure and mycological cure were observed in 33%, 15% and 56%, respectively, of patients in the luliconazole group compared to 15%, 4% and 27%, respectively, of patients in vehicle group.
Safety Notes
The most common adverse events (AEs) were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.
Phase III Tinea Cruris Clinical Data
Jones TM, Jarratt MT, Mendez-Moguel I, et al. A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥12 years with tinea cruris. J Drugs Dermatol. 2014;13(1):32-38.2
Study Objective
To assess the safety and efficacy of luliconazole in the treatment of patients with tinea cruris.1,2
Method
The randomized, double-blind, parallel-group, vehicle-controlled, multicenter, Phase III trial was conducted at 27 sites. Patients with a clinical and culture confirmed diagnosis of tinea cruris were randomized to treatment with luliconazole or vehicle. Patients applied either luliconazole or vehicle to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days. Signs and symptoms of tinea cruris (erythema, scaling and pruritus), positive KOH exam and dermatophyte culture were assessed at baseline, end of treatment (day 7), 2 and 3 weeks post-treatment.1,2
Population
A total of 483 patients age ≥12 years were enrolled and randomized to luliconazole (n=318) or vehicle (n=165) to obtain 256 patients in the modified intent-to-treat (MITT) population. Delayed exclusion of 153 patients in the luliconazole group and 74 patients in the vehicle group left an MITT population of 165 and 91 patients in the luliconazole and vehicle groups, respectively.2 Patients enrolled in the study had a mean age of 40 years, 83% were male, 58% were Caucasian and 34% were Black or African American.1,2
Primary Endpoints
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 3 weeks post-treatment.1
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).1
Results
The researchers concluded that luliconazole applied once daily for 7 days was more effective than vehicle and well-tolerated in patients with tinea cruris. At 3 weeks post-treatment, complete clearance was obtained in 21% of patients treated with luliconazole compared with 4% treated with vehicle (P<0.001). A larger percentage of patients in the luliconazole group compared with the vehicle group obtained effective treatment (43% vs 19%), clinical cure (24% vs 7%) and mycological cure (78% vs 45%), respectively; P<0.001.
Safety Notes
Phase III clinical trials with luliconazole found that the most common AEs were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.1 The most frequent treatment-emergent AEs (TEAEs) reported in the luliconazole group were headache, nasopharyngitis, dysmenorrhea and parasitic gastroenteritis. The most frequent TEAE reported in the vehicle group was headache. No other TEAE was reported by more than 2 patients.2
Additional Resource
Prescribing information for Luzu Cream 1%: https://www.luzurx.com/Content/docs/LUZU_Cream_MarketingPI_US.pdf.
The FDA approved Valeant Pharmaceuticals’ Luzu (luliconazole) Cream 1% in November 2013 for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients age 18 years and older.
Luliconazole is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a 1-week, once-daily treatment regimen — all other approved treatments require 2 weeks of treatment. Interdigital tinea pedis is approved with a 2-week, once-daily treatment.
Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.1
When treating interdigital tinea pedis, a thin layer of luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks. When treating tinea cruris or tinea corporis, luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week.1
Athlete’s foot between the toes is caused by a group of fungi called dermatophytes. Individuals can get the fungi by walking barefoot, wearing shoes that do not allow an individual’s feet to “breathe” or by touching the toes or feet of an individual who has it. Men are more prone than women to get athlete’s foot between the toes, and it also tends to affect individuals with a compromised immune system. Symptoms include itching, redness, peeling and discomfort.
Physicians can help patients prevent recurrence of athlete’s foot by educating them on the following tips from the American Academy of Dermatology and Mayo Clinic:
• Wash feet daily with soap and water and dry them well, especially between the toes
• Do not walk barefoot in public areas — wear flip-flops, sandals or water shoes instead
• When at home, take shoes off to let feet air out
• Avoid wearing closed shoes (especially vinyl or rubber ones) that make feet hot and sweaty — particularly during the summer
• Change socks regularly. If feet sweat often, change socks each time they get wet
• Do not borrow or share shoes
• Wear different shoes throughout the week to let shoes dry out
The FDA approved luliconazole based on positive results from 3 pivotal trials evaluating the safety and efficacy of luliconazole in 679 patients with either tinea pedis or tinea cruris.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trials that evaluated the safety and efficacy of luliconazole for the treatment of athlete’s foot and jock itch caused by T rubrum and E floccosum.
Phase III Interdigital Tinea Pedis Clinical Data
Luzu [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014.1
Study Objective
To assess the safety and efficacy of luliconazole to treatment of interdigital tinea pedis.
Method
The 2 randomized, double-blind, vehicle-controlled, multicenter, Phase III pivotal trials included patients with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Patients were randomized to receive luliconazole or vehicle. Patients applied either luliconazole or vehicle cream to forefeet including all the interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days. Signs and symptoms of tinea pedis (erythema, scaling and pruritus), potassium hydroxide (KOH) and dermatophyte culture were assessed at baseline, end of treatment (day 14), 2 and 4 weeks post-treatment.
Population
Studies included 423 patients. Study 1 included 106 patients in the luliconazole group and 103 patients in the vehicle group. Study 2 included 214 patients, with 107 patients each in the luliconazole and vehicle groups. The mean age of the study population was 41 years, 82% were male, 53% were Caucasian and 40% were Black or African American.
Primary Endpoint
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 4 weeks post-treatment.
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).
Results
At 4 weeks post-treatment in study 1, the researchers found that 26% of patients treated with luliconazole were cleared compared to 2% of patients treated with vehicle. In study 2, 14% of patients treated with luliconazole were cleared compared to 3% of patients treated with vehicle. Furthermore, luliconazole demonstrated greater efficacy results in secondary endpoints. In study 1, effective treatment, clinical cure and mycological cure were achieved by 48%, 29% and 62%, respectively, of patients in the luliconazole group versus 10%, 8% and 18%, respectively, of patients in the vehicle group. In study 2, effective treatment, clinical cure and mycological cure were observed in 33%, 15% and 56%, respectively, of patients in the luliconazole group compared to 15%, 4% and 27%, respectively, of patients in vehicle group.
Safety Notes
The most common adverse events (AEs) were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.
Phase III Tinea Cruris Clinical Data
Jones TM, Jarratt MT, Mendez-Moguel I, et al. A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥12 years with tinea cruris. J Drugs Dermatol. 2014;13(1):32-38.2
Study Objective
To assess the safety and efficacy of luliconazole in the treatment of patients with tinea cruris.1,2
Method
The randomized, double-blind, parallel-group, vehicle-controlled, multicenter, Phase III trial was conducted at 27 sites. Patients with a clinical and culture confirmed diagnosis of tinea cruris were randomized to treatment with luliconazole or vehicle. Patients applied either luliconazole or vehicle to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days. Signs and symptoms of tinea cruris (erythema, scaling and pruritus), positive KOH exam and dermatophyte culture were assessed at baseline, end of treatment (day 7), 2 and 3 weeks post-treatment.1,2
Population
A total of 483 patients age ≥12 years were enrolled and randomized to luliconazole (n=318) or vehicle (n=165) to obtain 256 patients in the modified intent-to-treat (MITT) population. Delayed exclusion of 153 patients in the luliconazole group and 74 patients in the vehicle group left an MITT population of 165 and 91 patients in the luliconazole and vehicle groups, respectively.2 Patients enrolled in the study had a mean age of 40 years, 83% were male, 58% were Caucasian and 34% were Black or African American.1,2
Primary Endpoints
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 3 weeks post-treatment.1
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).1
Results
The researchers concluded that luliconazole applied once daily for 7 days was more effective than vehicle and well-tolerated in patients with tinea cruris. At 3 weeks post-treatment, complete clearance was obtained in 21% of patients treated with luliconazole compared with 4% treated with vehicle (P<0.001). A larger percentage of patients in the luliconazole group compared with the vehicle group obtained effective treatment (43% vs 19%), clinical cure (24% vs 7%) and mycological cure (78% vs 45%), respectively; P<0.001.
Safety Notes
Phase III clinical trials with luliconazole found that the most common AEs were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.1 The most frequent treatment-emergent AEs (TEAEs) reported in the luliconazole group were headache, nasopharyngitis, dysmenorrhea and parasitic gastroenteritis. The most frequent TEAE reported in the vehicle group was headache. No other TEAE was reported by more than 2 patients.2
Additional Resource
Prescribing information for Luzu Cream 1%: https://www.luzurx.com/Content/docs/LUZU_Cream_MarketingPI_US.pdf.
The FDA approved Valeant Pharmaceuticals’ Luzu (luliconazole) Cream 1% in November 2013 for the topical treatment of athlete’s foot (interdigital tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients age 18 years and older.
Luliconazole is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a 1-week, once-daily treatment regimen — all other approved treatments require 2 weeks of treatment. Interdigital tinea pedis is approved with a 2-week, once-daily treatment.
Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase. Inhibition of this enzyme’s activity by azoles results in decreased amounts of ergosterol, a constituent of fungal cell membranes, and a corresponding accumulation of lanosterol.1
When treating interdigital tinea pedis, a thin layer of luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks. When treating tinea cruris or tinea corporis, luliconazole should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week.1
Athlete’s foot between the toes is caused by a group of fungi called dermatophytes. Individuals can get the fungi by walking barefoot, wearing shoes that do not allow an individual’s feet to “breathe” or by touching the toes or feet of an individual who has it. Men are more prone than women to get athlete’s foot between the toes, and it also tends to affect individuals with a compromised immune system. Symptoms include itching, redness, peeling and discomfort.
Physicians can help patients prevent recurrence of athlete’s foot by educating them on the following tips from the American Academy of Dermatology and Mayo Clinic:
• Wash feet daily with soap and water and dry them well, especially between the toes
• Do not walk barefoot in public areas — wear flip-flops, sandals or water shoes instead
• When at home, take shoes off to let feet air out
• Avoid wearing closed shoes (especially vinyl or rubber ones) that make feet hot and sweaty — particularly during the summer
• Change socks regularly. If feet sweat often, change socks each time they get wet
• Do not borrow or share shoes
• Wear different shoes throughout the week to let shoes dry out
The FDA approved luliconazole based on positive results from 3 pivotal trials evaluating the safety and efficacy of luliconazole in 679 patients with either tinea pedis or tinea cruris.1,2
The Dermatologist Product Spotlight provides a summary of the pivotal trials that evaluated the safety and efficacy of luliconazole for the treatment of athlete’s foot and jock itch caused by T rubrum and E floccosum.
Phase III Interdigital Tinea Pedis Clinical Data
Luzu [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2014.1
Study Objective
To assess the safety and efficacy of luliconazole to treatment of interdigital tinea pedis.
Method
The 2 randomized, double-blind, vehicle-controlled, multicenter, Phase III pivotal trials included patients with a clinical and culture-confirmed diagnosis of interdigital tinea pedis. Patients were randomized to receive luliconazole or vehicle. Patients applied either luliconazole or vehicle cream to forefeet including all the interdigital web spaces and approximately 2.5 cm (1 in) of the surrounding area of the foot once daily for 14 days. Signs and symptoms of tinea pedis (erythema, scaling and pruritus), potassium hydroxide (KOH) and dermatophyte culture were assessed at baseline, end of treatment (day 14), 2 and 4 weeks post-treatment.
Population
Studies included 423 patients. Study 1 included 106 patients in the luliconazole group and 103 patients in the vehicle group. Study 2 included 214 patients, with 107 patients each in the luliconazole and vehicle groups. The mean age of the study population was 41 years, 82% were male, 53% were Caucasian and 40% were Black or African American.
Primary Endpoint
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 4 weeks post-treatment.
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).
Results
At 4 weeks post-treatment in study 1, the researchers found that 26% of patients treated with luliconazole were cleared compared to 2% of patients treated with vehicle. In study 2, 14% of patients treated with luliconazole were cleared compared to 3% of patients treated with vehicle. Furthermore, luliconazole demonstrated greater efficacy results in secondary endpoints. In study 1, effective treatment, clinical cure and mycological cure were achieved by 48%, 29% and 62%, respectively, of patients in the luliconazole group versus 10%, 8% and 18%, respectively, of patients in the vehicle group. In study 2, effective treatment, clinical cure and mycological cure were observed in 33%, 15% and 56%, respectively, of patients in the luliconazole group compared to 15%, 4% and 27%, respectively, of patients in vehicle group.
Safety Notes
The most common adverse events (AEs) were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.
Phase III Tinea Cruris Clinical Data
Jones TM, Jarratt MT, Mendez-Moguel I, et al. A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥12 years with tinea cruris. J Drugs Dermatol. 2014;13(1):32-38.2
Study Objective
To assess the safety and efficacy of luliconazole in the treatment of patients with tinea cruris.1,2
Method
The randomized, double-blind, parallel-group, vehicle-controlled, multicenter, Phase III trial was conducted at 27 sites. Patients with a clinical and culture confirmed diagnosis of tinea cruris were randomized to treatment with luliconazole or vehicle. Patients applied either luliconazole or vehicle to the affected area and approximately 2.5 cm (1 in) of the surrounding area once daily for 7 days. Signs and symptoms of tinea cruris (erythema, scaling and pruritus), positive KOH exam and dermatophyte culture were assessed at baseline, end of treatment (day 7), 2 and 3 weeks post-treatment.1,2
Population
A total of 483 patients age ≥12 years were enrolled and randomized to luliconazole (n=318) or vehicle (n=165) to obtain 256 patients in the modified intent-to-treat (MITT) population. Delayed exclusion of 153 patients in the luliconazole group and 74 patients in the vehicle group left an MITT population of 165 and 91 patients in the luliconazole and vehicle groups, respectively.2 Patients enrolled in the study had a mean age of 40 years, 83% were male, 58% were Caucasian and 34% were Black or African American.1,2
Primary Endpoints
• The primary endpoint was complete clearance (defined as clinical cure and mycological cure) at 3 weeks post-treatment.1
Secondary Endpoints
• Secondary endpoints included effective treatment (negative KOH and culture and at most mild erythema and/or scaling and no pruritus), clinical cure (absence of erythema, scaling and pruritus) and mycological cure (negative KOH and negative fungi culture).1
Results
The researchers concluded that luliconazole applied once daily for 7 days was more effective than vehicle and well-tolerated in patients with tinea cruris. At 3 weeks post-treatment, complete clearance was obtained in 21% of patients treated with luliconazole compared with 4% treated with vehicle (P<0.001). A larger percentage of patients in the luliconazole group compared with the vehicle group obtained effective treatment (43% vs 19%), clinical cure (24% vs 7%) and mycological cure (78% vs 45%), respectively; P<0.001.
Safety Notes
Phase III clinical trials with luliconazole found that the most common AEs were application site reactions, which occurred in <1% of patients for both the luliconazole and vehicle arms. Most AEs were mild in severity.1 The most frequent treatment-emergent AEs (TEAEs) reported in the luliconazole group were headache, nasopharyngitis, dysmenorrhea and parasitic gastroenteritis. The most frequent TEAE reported in the vehicle group was headache. No other TEAE was reported by more than 2 patients.2
Additional Resource
Prescribing information for Luzu Cream 1%: https://www.luzurx.com/Content/docs/LUZU_Cream_MarketingPI_US.pdf.
