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CompletedNCT07718685Updated Jul 22, 2026

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

An interventional study of Oxiconazole Nitrate Cream and Clotrimazole Cream in Dermatophytoses, sponsored by Shalamar Institute of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Shalamar Institute of Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dermatophytoses

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03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    Oxiconazole group

    Group participants will receive oxiconazole cream treatment

    Drug: Oxiconazole Nitrate Cream

  • Experimental
    Clotrimazole group

    Group participants will receive clotrimazole cream treatment

    Drug: Clotrimazole Cream

Interventions

  • DrugOxiconazole Nitrate Cream

    Oxiconazole 1 % cream will be applied on dermatophytosis lesions

  • DrugClotrimazole Cream

    Clotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions

05

What researchers measure

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.

    Time frame: 6 months

06

Study locations

1 site
  • Shalamar hospital
    Lahore, Punjanb 54840, Pakistan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07718685
Lead sponsor
Shalamar Institute of Health Sciences
Responsible party
Iqra Afzal (Post graduate resident, Shalamar Institute of Health Sciences) — Principal investigator
First posted
Jul 22, 2026
Start date
Jan 1, 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Jul 22, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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