An Open-Label, Randomized, Double-Arm Clinical Trial to Compare the Effectiveness and Safety of Super Bioavailable Itraconazole Capsules and Itraconazole Capsules in the Management of Dermatophytosis in India

Figures & data

Figure 1 Study design.

Table 1 Baseline Demographic Characteristics

Parameters	Conventional Itraconazole	Super Bioavailable Itraconazole	p Value
N	33	26
Male, n (%)	25 (75.8)	15 (57.7)	0.16
Female, n (%)	8 (24.2)	11 (42.3)
Age (years), mean±SD	37.11±10.93	34.60±11.38	0.39
Distribution of anatomical site of infection
Multisite, n (%)	6 (18.2)	7 (26.9)	0.53
Tinea cruris et corporis, n (%)	24 (72.7)	15 (57.7)	0.27
Tinea cruris, n (%)	1 (3)	1 (3.8)	1
Tinea corporis, n (%)	2 (6.1)	2 (7.7)	1
Tinea faciei	0	1 (3.8)
No. of lesions
1–2 lesions, n (%)	1 (3)	3 (11.5)	0.31
3–4 lesions, n (%)	8 (24.2)	6 (23.1)	1
≥5 lesions, n (%)	26 (78.8)	17 (65.4)	0.37
Type of disease
Naïve, n (%)	1 (3)	3 (11.5)	0.31
Recurrence, n (%)	13 (39.4)	8 (30.8)	0.58
Chronic, n (%)	19 (57.6)	15 (57.7)	1
Previous treatment
Chemist, n (%)	12 (36.4)	9 (34.6)	1
Dermatologist, n (%)	13 (39.4)	11 (42.3)	1
Topical steroids, n (%)	8 (24.2)	6 (23.1)	1
Effectiveness evaluation score
Total symptom score (TSS), mean±SD	9.73±1.59	9.35±1.32	0.33
Body surface area (BSA), mean±SD	2.23±0.55	1.94±0.68	0.07
Investigator’s global assessment (IGA) score, mean±SD	2.54±0.51	2.40±0.5	0.2

Table 2 Effectiveness Evaluation in Chronic, Recurrent and Naïve Patients

Parameters	Conventional Itraconazole	Super Bioavailable Itraconazole	p Value
Effectiveness evaluation (N)	33	26
Complete cure	11	17	0.01*
Mycological cure	22	22	0.14
Recurrence	1	4	0.15
Chronic dermatophytosis (N)	19	15
Complete cure	5	9	0.08
Mycological cure	11	14	0.04*
Recurrence	1	4	0.14
Recurrent dermatophytosis (N)	13	8
Complete cure	6	5	0.65
Mycological cure	10	5	0.63
Recurrence	0	0
Naïve dermatophytosis (N)	1	3
Complete cure	0	3	0.25
Mycological cure	1	3	0.25
Recurrence	0	0

Note: *Statistically significant values.

Figure 2 Clinical improvement in SBITZ group: (A) before SBITZ and (B) after SBITZ treatment; (C) before SBITZ and (D) after SBITZ treatment.

Figure 3 Clinical improvement in CITZ group: (A) before CITZ and (B) after CITZ treatment.

Table 3 Mean Scores at Baseline, Week 2, and Week 4 in Both Treatment Groups

Efficacy Evaluation Score
Parameters	Conventional Itraconazole	Super Bioavailable Itraconazole	p Value
TSS
Baseline	9.73±1.59	9.35±1.32	0.33
Day 14	4.06±1.77	3.15±1.35	0.03*
Day 28	1.58±1.90	0.65±1.09	0.03*
BSA
Baseline	2.23±0.55	1.94±0.68	0.07
Day 14	1.27±0.63	0.88±0.59	0.01*
Day 28	0.48±0.63	0.15±0.37	0.02*
IGA
Baseline	2.54±0.51	2.40±0.5	0.2
Day 14	1.30±0.53	1.05±0.27	0.03*
Day 28	0.53±0.67	0.20±0.51	0.04*

Note: *Statistically significant values.

Figure 4 Percent reduction in mean scores.