Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:56 PM
Study NCT ID:
NCT07441005
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Efficacy of Topical Oxiconazole Cream (1%) Versus Topical Clotrimazole Cream (1%) in the Treatment of Tinea CrurisAbstract
Sponsor:
Hayat Abad Medical Complex, Peshawar
Organization:
Study Overview
Official Title:
Comparative Efficacy of Topical Oxiconazole Cream (1%) Versus Topical Clotrimazole Cream (1%) in the Treatment of Tinea CrurisAbstract
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is conducted to compare the efficacy of topical oxiconazole 1% cream versus topical clotrimazole 1% cream in patients with tinea cruris.
Detailed Description:
Comparative Efficacy of Topical Oxiconazole Cream (1%) Versus Topical Clotrimazole Cream (1%) in the Treatment of Tinea Cruris Abstract Objective: To compare the efficacy of topical oxiconazole 1% cream versus topical clotrimazole 1% cream in patients with tinea cruris.
Study Design: Randomized Controlled Trial. Place and Duration of Study: Department of Dermatology, Hayatabad Medical Complex, Peshawar, from Methodology: A total of 386 patients with clinically diagnosed tinea cruris confirmed by potassium hydroxide (KOH) mount were enrolled through consecutive sampling and randomized into two equal groups (n=193 each). Group A received topical clotrimazole 1% cream and Group B received topical oxiconazole 1% cream. Symptoms (pruritus, erythema, vesicles, and desquamation) were graded on a 0-3 scale (total score 0-12) at baseline and at Week 4. Efficacy was defined as ≥50% reduction in total symptom score at Week 4. Data were analyzed using SPSS version 25. Between-group comparisons were performed using appropriate parametric/non-parametric tests and chi-square test, with p≤0.05 considered significant.
Key words: Tinea cruris; Dermatophytosis; Clotrimazole; Oxiconazole; Topical antifungal; Randomized controlled trial; Pruritus; Erythema; Clinical efficacy.
Introduction Dermatophytosis is among the most frequent superficial fungal infections, affecting approximately 20-25% of the global population.¹ It represents a significant health problem, particularly in tropical regions such as Central Asia, where the hot and humid climate favors its occurrence.¹ In Central Asia, the commonest clinical forms include tinea corporis (36-59%) and tinea cruris (12-27%).¹ Although dermatophytosis is not typically fatal, it causes considerable morbidity by interfering with daily activities, reducing quality of life, and increasing healthcare expenditure.
Treatment strategies for dermatophytosis involve the use of systemic or topical antifungal agents. However, topical therapy is generally preferred over oral treatment because it has fewer adverse effects, avoids drug-drug interactions, offers better compliance, and is less costly.² Clotrimazole has been widely used as a topical treatment for tinea corporis/cruris for more than 25 years. Nevertheless, it has drawbacks such as a relatively long treatment duration, which can result in poor compliance and may be associated with higher relapse rates, partly attributed to the rapid emergence of reduced susceptibility.³ To address the growing burden of superficial fungal infections, newer broad-spectrum antifungals such as sertaconazole have expanded available treatment options.⁴ Oxiconazole is a newer topical imidazole antifungal and has been shown in several studies to be more effective than conventional azoles. It allows shorter treatment courses and has been linked with lower relapse rates. It demonstrates both fungistatic and fungicidal activity against dermatophytes. In addition, it provides concomitant symptom control and thus may improve the quality of life of patients with dermatophytosis.⁵
Methodology:
This randomized controlled trial was conducted in the Department of Dermatology, Hayatabad Medical Complex, Peshawar, over a period of six months after approval of the synopsis. Using non-probability consecutive sampling, 386 patients with tinea cruris were enrolled from the dermatology outpatient department after institutional approval and written informed consent. Patients aged 18-60 years of either gender having clinically suspected tinea cruris with positive KOH mount were included. Patients with mixed/extensive fungal infection requiring systemic therapy, other concomitant inflammatory dermatoses involving the groin, known hypersensitivity to azole antifungals, pregnancy or lactation, immunosuppression, and those who had used topical antifungals/corticosteroids or systemic antifungals recently were excluded. Participants were allocated in a 1:1 ratio to Group A (topical clotrimazole 1% cream) or Group B (topical oxiconazole 1% cream) through blocked randomization with allocation concealment using sequentially numbered opaque sealed envelopes; outcome assessment was performed by an assessor blinded to treatment allocation. Both groups were instructed to apply the assigned medication twice daily to the affected area for four weeks. Baseline demographics (age, gender, BMI, duration of complaints, residence, education, profession, and socioeconomic status) were recorded. Clinical severity was assessed at baseline and Week 4 using a standardized symptom score comprising pruritus, erythema, vesicles, and desquamation (each graded 0-3, total score 0-12). Efficacy was defined as ≥50% reduction in total symptom score at Week 4.
Study Design: Randomized Controlled Trial. Place and Duration of Study: Department of Dermatology, Hayatabad Medical Complex, Peshawar, from Methodology: A total of 386 patients with clinically diagnosed tinea cruris confirmed by potassium hydroxide (KOH) mount were enrolled through consecutive sampling and randomized into two equal groups (n=193 each). Group A received topical clotrimazole 1% cream and Group B received topical oxiconazole 1% cream. Symptoms (pruritus, erythema, vesicles, and desquamation) were graded on a 0-3 scale (total score 0-12) at baseline and at Week 4. Efficacy was defined as ≥50% reduction in total symptom score at Week 4. Data were analyzed using SPSS version 25. Between-group comparisons were performed using appropriate parametric/non-parametric tests and chi-square test, with p≤0.05 considered significant.
Key words: Tinea cruris; Dermatophytosis; Clotrimazole; Oxiconazole; Topical antifungal; Randomized controlled trial; Pruritus; Erythema; Clinical efficacy.
Introduction Dermatophytosis is among the most frequent superficial fungal infections, affecting approximately 20-25% of the global population.¹ It represents a significant health problem, particularly in tropical regions such as Central Asia, where the hot and humid climate favors its occurrence.¹ In Central Asia, the commonest clinical forms include tinea corporis (36-59%) and tinea cruris (12-27%).¹ Although dermatophytosis is not typically fatal, it causes considerable morbidity by interfering with daily activities, reducing quality of life, and increasing healthcare expenditure.
Treatment strategies for dermatophytosis involve the use of systemic or topical antifungal agents. However, topical therapy is generally preferred over oral treatment because it has fewer adverse effects, avoids drug-drug interactions, offers better compliance, and is less costly.² Clotrimazole has been widely used as a topical treatment for tinea corporis/cruris for more than 25 years. Nevertheless, it has drawbacks such as a relatively long treatment duration, which can result in poor compliance and may be associated with higher relapse rates, partly attributed to the rapid emergence of reduced susceptibility.³ To address the growing burden of superficial fungal infections, newer broad-spectrum antifungals such as sertaconazole have expanded available treatment options.⁴ Oxiconazole is a newer topical imidazole antifungal and has been shown in several studies to be more effective than conventional azoles. It allows shorter treatment courses and has been linked with lower relapse rates. It demonstrates both fungistatic and fungicidal activity against dermatophytes. In addition, it provides concomitant symptom control and thus may improve the quality of life of patients with dermatophytosis.⁵
Methodology:
This randomized controlled trial was conducted in the Department of Dermatology, Hayatabad Medical Complex, Peshawar, over a period of six months after approval of the synopsis. Using non-probability consecutive sampling, 386 patients with tinea cruris were enrolled from the dermatology outpatient department after institutional approval and written informed consent. Patients aged 18-60 years of either gender having clinically suspected tinea cruris with positive KOH mount were included. Patients with mixed/extensive fungal infection requiring systemic therapy, other concomitant inflammatory dermatoses involving the groin, known hypersensitivity to azole antifungals, pregnancy or lactation, immunosuppression, and those who had used topical antifungals/corticosteroids or systemic antifungals recently were excluded. Participants were allocated in a 1:1 ratio to Group A (topical clotrimazole 1% cream) or Group B (topical oxiconazole 1% cream) through blocked randomization with allocation concealment using sequentially numbered opaque sealed envelopes; outcome assessment was performed by an assessor blinded to treatment allocation. Both groups were instructed to apply the assigned medication twice daily to the affected area for four weeks. Baseline demographics (age, gender, BMI, duration of complaints, residence, education, profession, and socioeconomic status) were recorded. Clinical severity was assessed at baseline and Week 4 using a standardized symptom score comprising pruritus, erythema, vesicles, and desquamation (each graded 0-3, total score 0-12). Efficacy was defined as ≥50% reduction in total symptom score at Week 4.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: