Comparative Study of Topical Oxiconazole 1% Cream Versus Clotrimazole 1% Cream in the Treatment of Dermatophytosis

To compare the efficacy of oxiconazole 1 % cream and clotrimazole cream for treatment of dermatophytosis

Study Overview

• Status: Completed
• Conditions: Dermatophytoses
• Intervention / Treatment: Drug: Oxiconazole Nitrate Cream; Drug: Clotrimazole Cream

Detailed Description

Following approval from the hospital ethical committee, informed consent will be obtained from all patients, with basic information including name, age, gender, baseline clinical score, and location of dermatophytosis noted. A total of 164 patients will be evenly divided into two groups, each comprising 82 patients, utilizing a lottery method. In Group A, 1% oxiconazole cream will be applied once daily on skin lesions, while in Group B, 1% clotrimazole cream will be applied twice daily on the affected skin area. Tab. certirizine 10mg will be taken by patients of both groups at night for itching. The treatment will be continued for 1 month, and patients will do follow up visit at 2nd and 4th week from baseline. The clinical score will be assessed and photographs will be taken at each visit. Clinical assessment score will be will be made on the parameters of erythema, pruritus, and scaling, ranging from 0 (absent) to 3 (severe) for each parameter, with a maximum total score of 9.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjanb
    • Lahore, Punjanb, Pakistan, 54840
      • Shalamar hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18 years and above
• Patients diagnosed with dermatophytosis per operational definition, involving less than 10% body surface area, that does not necessitate oral antifungal treatment (as assessed by the researcher).
• Both males and females.

Exclusion Criteria:

• History of hypersensitivity to azole drugs or vehicle ingredients.
• Use of any antifungal agents within past four weeks.
• Use of topical corticoseroids within past two weeks.
• Pregnant and lactating mothers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxiconazole group; Group participants will receive oxiconazole cream treatment	Drug: Oxiconazole Nitrate Cream; Oxiconazole 1 % cream will be applied on dermatophytosis lesions
Experimental: Clotrimazole group; Group participants will receive clotrimazole cream treatment	Drug: Clotrimazole Cream; Clotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in terms of clearance of lesions , pruritis and scaling	Efficacy as complete clinical cure at the conclusion of the treatment period. Complete clinical cure will be considered 0 score on Clinical Assessment Score (CAS). Clinical Assessment Score: It will be assessed on the parameters of erythema, pruritus, and scaling, ranging from 0 (absent) to 3 (severe) for each parameter, with a maximum total score of 9.	6 months

Collaborators and Investigators

• Sponsor: Shalamar Institute of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Skin and Connective Tissue Diseases; Tinea
• Other Study ID Numbers: ShalamarIRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No