Itraconazole pulse therapy vs ketoconazole shampoo for scalp seborrheic dermatitis
Official title: The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp. A Randomized Control Trial
Run by Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan · NCT07734441 · Data updated 2026-11-12
This study tests whether pulse oral itraconazole works better than ketoconazole shampoo for people with moderate to severe scalp seborrheic dermatitis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan Academic / other |
| Locations | 1 site (Chak Eighty-seven -Twelve Left, Punjab Province) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | September 7, 2026 |
| Study ends | September 7, 2026 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07734441 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 14–70 with moderate to severe scalp seborrheic dermatitis seeking systemic or topical therapy options.
✕Probably not a fit
Patients with significant heart disease, liver disease, or those on conflicting medications may not benefit and could be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label trial compares two treatments for moderate to severe scalp seborrheic dermatitis: oral itraconazole given in pulse regimens over six months versus topical 2% ketoconazole shampoo with daily then twice-weekly use. Participants aged 14 to 70 with scalp SD are enrolled and assigned to one of the two treatment arms, with outcomes measured by SSD scores and global impressions from clinicians and patients. The study aims to see differences in treatment effectiveness, relapse frequency, patient satisfaction, and side effects, using standard statistical analysis. Malassezia-related inflammation and risk of hepatotoxicity with itraconazole are considerations guiding safety and interpretation.
Why it matters
Potential benefit: If itraconazole proves more effective, patients might experience better control of symptoms and fewer relapses.
How similar studies have gone: Evidence from antifungal approaches supports using ketoconazole for SD, with limited direct comparisons to itraconazole in scalp disease; this study tests a novel head-to-head approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are interested in taking part in research are between the ages of 14-17 with people who have scalp SD ranging from moderate to severe. Exclusion Criteria: * Patients with heart disease. Pregnant women or lactating women liver disease patients as itraconazole can be hepatotoxic uncontrolled hypertension patient taking multiple drugs like oral antidiabetics, lipid lowering drugs, sedatives patient has history to hypersensitvity to either of drugs.
Where it's running
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CMH Bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan Recruiting
Study contacts
- Study coordinator: Bakhtawar Rehman, MBBS, FCPS Dermatology
- Email: bakhtawar.rehman09@gmail.com
- Phone: 03328883135
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.