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Effect of Pramiconazole on Signs and Symptoms of Tinea Cruris/Corporis

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Effect of Pramiconazole on Signs and Symptoms of Tinea Cruris/Corporis Open Label Phase IIa Trials to Evaluate the Effects of Short Term Oral Pramiconazole in Tinea Pedis and Tinea Cruris/Corporis 1Jacques Decroix, 2Jannie Ausma, 2Luc Wouters, 2Marcel Borgers, 2Lieve Vandeplassche 1Avenue du Parc 39, Mouscron, Belgium and 2Barrier Therapeutics, Geel, Belgium Introduction Efficacy Results Tinea Pedis Efficacy Results Tinea Cruris/Corporis Table 3: Effect of pramiconazole on signs and symptoms of tinea Pramiconazole, previously referred to as R126638, is a broad spectrum antifungal Table 1: Effect of pramiconazole on signs and symptoms of tinea pedis belonging to the class of triazoles. It has excellent potential for oral and topical cruris/corporis treatment of fungal infections of skin, hair, nails, oral and genital mucosa. In vitro data Day All Patients Cohort I Cohort II Day All Patients Cohort I Cohort II demonstrated its activity against dermatophytes (Trichophyton spp., Microsporum (3 & 5 days) (3 days) (5 days) (3 & 5 days) (3 days) (5 days) canis, Epidermophyton floccosum), yeasts and many other fungi. Furthermore, Total Signs & 1 9.9 (3-14) 10.2 (8-12) 9.5 (3-14) Total Signs & 1 5.8 (4-9) 6.1 (8-12) 5.6 (3-14) efficacy studies in animals provided evidence for a potent therapeutic effect of Symptoms 4/6 7.2 (2-11) <.001 7.8 (6-11) 0.004 6.6 (2-11) 0.002 Symptoms 4/6 4.8 (3-7) <.001 5.0 (6-11) 0.063 4.6 (2-11) 0.031 R126638 that proved to be 3- to 8-fold superior over that of itraconazole, especially Score** 14 3.4 (1-6) <.001 3.3 (2-5) 0.002 3.5 (1-6) 0.002 Score** 14 2.8 (2-4) <.001 2.9 (2-5) 0.004 2.7 (1-6) 0.004 for superficial fungal infections. The strong activity of R126638 is ascribed to its 28 1.3 (0-2) <.001 1.1 (0-2) 0.002 1.4 (0-2) 0.002 28 1.3 (0-4) <.001 1.8 (0-2) 0.004 0.8 (0-2) 0.004 prominent affinity for fungal cytochrome P450, which is involved in the biosynthesis of ergosterol from lanosterol. Activity of R126638 against several dermatophytes, Desquamation* 1 2.8 (1-3) 2.9 (2-3) 2.7 (1-3) Desquamation* 1 2.6 (2-3) 2.4 (2-3) 2.7 (2-3) including T. rubrum and M.canis was demonstrated in the stratum corneum of 4/6 2.5 (1-3) 0.031 2.6 (2-3) 0.250 2.4 (1-3) 0.250 4/6 2.2 (1-3) 0.031 2.3 (2-3) 1.000 2.1 (1-3) 0.063 healthy volunteers dosed daily for 1 week with 100 or 200 mg R126638. 14 1.5 (1-2) <.001 1.5 (1-2) 0.002 1.5 (1-2) 0.004 14 1.4 (1-2) <.001 1.3 (1-2) 0.004 1.4 (1-2) 0.008 28 0.8 (0-1) <.001 0.8 (0-1) 0.002 0.8 (0-1) 0.004 28 0.8 (0-2) <.001 0.8 (0-1) 0.004 0.6 (0-1) 0.004 Objective Erythema* 1 2.5 (0-3) 2.5 (0-3) 2.4 (0-3) Erythema* 1 2.7 (1-3) 2.8 (2-3) 3.6 (1-3) 4/6 2.1 (0-3) 0.008 2.3 (0-3) 0.500 1.8 (0-3) 0.031 4/6 2.4 (1-3) 0.125 2.6 (2-3) 0.500 2.3 (1-3) 0.500 To evaluate the efficacy of oral treatment with a daily dose of 200 mg pramiconazole 14 1.3 (0-2) <.001 1.2 (0-2) 0.004 1.4 (0-2) 0.004 14 1.4 (1-2) <.001 1.6 (1-2) 0.004 1.2 (1-2) 0.008 in tinea pedis and tinea cruris/corporis for 3 or 5 consecutive days (D). 28 0.5 (0-1) <.001 0.3 (0-1) 0.004 0.6 (0-1) 0.004 28 0.5 (0-2) <.001 0.8 (0-2) 0.004 0.2 (0-1) 0.004 Mean (min-max); P-values compared to baseline. Mean (min-max); P-values compared to baseline. ** Sum of individual signs and symptoms (desquamation, exudation/incrustation, ** Sum of individual signs and symptoms (desquamation, exudation/incrustation, Patients and Methods vesiculation/pustules, maceration, fissures, erythema, pruritus, burning/pain). vesiculation/pustules, maceration, fissures, erythema, pruritus, burning/pain). * 5-points scale for individual signs and symptoms (0=absent, 4=severe). * 5-points scale for individual signs and symptoms (0=absent, 4=severe). Key Inclusion criteria: Mycological evaluation at day 28 resulted in a negative KOH microscopy for 60% Mycological evaluation at day 28 resulted in a negative KOH microscopy for 44% 1. Male or female of the patients in cohort I and 70% in cohort II. Negative cultures obtained at day of the patients in cohort I and 89% in cohort II. Negative cultures obtained at day 2. Age between 18 and 70 years 28 were seen in 40% of cohort I and in 70% of cohort II. “Marked improvement” 28 were seen in 44% of cohort I and in 67% of cohort II. “Marked improvement” or 3. Clinical diagnosis of tinea pedis or tinea cruris/corporis (confirmed by a or “cured” was obtained in all patients of cohort I and in 90% of the patients of “cured” was obtained in 78% of the patients of cohort I and in 100% of the patients positive KOH test) cohort II at day 28. The mean value of total signs and symptoms score was 10 for of cohort II at day 28. The mean value of total signs and symptoms score was 5.8 both cohorts before inclusion, and was reduced at day 14 towards 3.3 for cohort I for both cohorts before inclusion, and was reduced at day 14 towards 2.8 (p<0.001 Key Exclusion criteria: and 3.5 for cohort II (p=0.002 vs. baseline for both cohorts). At day 28 the median vs. baseline for both cohorts). At day 28 the mean value was 1.8 for cohort I and value was 1.1 for cohort I and 1.4 for cohort II (p=0.002 for both cohorts). 0.8 for cohort II (p=0.004 for both cohorts). 1. Onychomycosis or pityriasis versicolor 2. Use of medication contraindicated for azole treatment or that influences the bioavailability of azoles Table 2: Tinea pedis percentage responders at day 28 Table 4: Tinea cruris/corporis percentage responders at day 28 3. Use of any local or systemic antimycotic therapy two weeks (local) or four All Patients Cohort I Cohort II All Patients Cohort I Cohort II weeks (systemic) before entry into the study and during the complete study period (3 & 5 days) (3 days) (5 days) (3 & 5 days) (3 days) (5 days) 4. Immunosuppression Negative KOH microscopy 65% 60% 70% Negative KOH microscopy 67% 44% 89% 5. Presence of significant infection that required systemic antibiotic treatment Negative Culture 55% 40% 70% Negative Culture 56% 44% 67% 6. Pregnant or breast-feeding women or women of childbearing potential. Clinical response$ 95% 100% 90% Clinical response$ 89% 78% 100% Twenty patients were included in the tinea pedis study: 10 patients in cohort I (3 days treatment) and 10 patients in cohort II(5 days treatment), whereas 18 patients were Mycological eradication: negative KOH microscopy and culture. Mycological eradication: negative KOH microscopy and culture. included in the tinea cruris/corporis study: 9 patients in cohort I (3 days treatment) $Clinical response: global clinical evaluation of “cured” or “marked improvement”. $Clinical response: global clinical evaluation of “cured” or “marked improvement”. and 9 patients in cohort II (5 days treatment). The evaluations were performed before inclusion, at day 4 (cohort I) or day 6 (cohort II), day 14 and day 28 after onset of treatment. The effects of pramiconazole on mycological outcome were evaluated by Safety Results Conclusion KOH microscopy and culture on scales taken at the border of an active lesion. For the clinical signs and symptoms, a global clinical evaluation was made and signs and There were no serious adverse events (SAE) reported. None of the patients Results from the phase IIa trials indicate that pramiconazole appears to be symptoms were evaluated. At every follow-up visit the global clinical evaluation was discontinued the trials due to an AE. Only 4 patients reported at least one AE, effective for the treatment of tinea pedis and tinea cruris/corporis with relatively made on a 5-point scale (0=worse, 1=unchanged, 2=mild/moderate improvement, which were scored as mild to severe in severity. The reported AEs were classified short oral treatment courses. Further studies using short term treatment with 3=marked improvement, 4=cured). Individual signs and symptoms were all as possibly or very likely related to trial medication. Vital signs and laboratory pramiconazole in tinea are warranted to confirm the observed effects. scored on a 4-point scale and the sum of the score was calculated for every visit. values did not reveal marked changes compared to baseline. .
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