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

NCT07718685 | Completed

• 1 other identifier: ShalamarIRB
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dermatophytoses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oxiconazole group

EXPERIMENTAL

Group participants will receive oxiconazole cream treatment

Drug: Oxiconazole Nitrate Cream

Clotrimazole group

EXPERIMENTAL

Group participants will receive clotrimazole cream treatment

Drug: Clotrimazole Cream

Interventions

Clotrimazole Cream DRUG

Clotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions

Clotrimazole group

Oxiconazole Nitrate Cream DRUG

Oxiconazole 1 % cream will be applied on dermatophytosis lesions

Oxiconazole group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalamar Institute of Health Sciences: lead

Study Sites (1)

Shalamar hospital

Lahore, Punjanb, 54840, Pakistan

Location

MeSH Terms

Conditions

Tinea

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate resident

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: July 22, 2026
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 22, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)