DermatophytosesNCT07718685
Comparative Study of Topical Oxiconazole 1% Cream Versus Clotrimazole 1% Cream in the Treatment of Dermatophytosis
A study testing Oxiconazole Nitrate Cream and Clotrimazole Cream in people with Dermatophytoses, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
To compare the efficacy of oxiconazole 1 % cream and clotrimazole cream for treatment of dermatophytosis Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatophytoses
- What is being tested?
- Oxiconazole Nitrate Cream and Clotrimazole Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dermatophytoses
- Being tested
- Oxiconazole Nitrate Cream, Clotrimazole Cream
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiconazole Nitrate CreamDrug
Oxiconazole 1 % cream will be applied on dermatophytosis lesions
Clotrimazole CreamDrug
Clotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions
| Study group | Role | What they receive |
|---|---|---|
| Oxiconazole group | Experimental | Group participants will receive oxiconazole cream treatment Receives: Drug: Oxiconazole Nitrate Cream |
| Clotrimazole group | Experimental | Group participants will receive clotrimazole cream treatment Receives: Drug: Clotrimazole Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatophytosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iqra Afzal, Shalamar Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718685
- Sponsor's protocol ID
- ShalamarIRB
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Topical Oxiconazole 1% Cream Versus Clotrimazole 1% Cream in the Treatment of Dermatophytosis
- ClinicalTrials.gov ID
- NCT07718685
- Acronym / sponsor ID
- ShalamarIRB
- Conditions
- Dermatophytoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of oxiconazole 1 % cream and clotrimazole cream for treatment of dermatophytosis
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxiconazole group | Experimental | Drug: Oxiconazole Nitrate CreamGroup participants will receive oxiconazole cream treatment |
| Clotrimazole group | Experimental | Drug: Clotrimazole CreamGroup participants will receive clotrimazole cream treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxiconazole Nitrate CreamOxiconazole 1 % cream will be applied on dermatophytosis lesions | Drug | Oxiconazole group |
| Clotrimazole CreamClotrimazole cream will be applied to clotrimazole group on dermatophytosis lesions | Drug | Clotrimazole group |
Primary outcome
Efficacy in terms of clearance of lesions , pruritis and scaling
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Dermatophytoses
Not yet recruitingPhase 4
Comparative Efficacy of Luliconazole and Bifonazole Combined With Itraconazole in Dermatophytosis
Tinea Corporis,Tinea Cruris,Tinea Faciei
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Not yet recruitingObservational study
Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in Children
Fungal Infection by Site, Tinea Capitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiconazole Nitrate Cream and Clotrimazole Cream in people with Dermatophytoses, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in terms of clearance of lesions , pruritis and scaling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.