RecruitingEarly Phase 1

The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.

Pakistan80 participantsStarted 2026-01-07

Plain-language summary

This study is a randomized controlled trial comparing the effectiveness of oral itraconazole pulse therapy versus topical 2% ketoconazole shampoo in treating moderate to severe scalp seborrheic dermatitis (SD). SD is a chronic inflammatory skin condition associated with Malassezia yeast, characterized by scaling, itching, and redness, significantly affecting quality of life. A total of 80 participants aged (14-70 years) with moderate to severe scalp SD will be enrolled and divided into two groups. Group A will receive oral itraconazole (pulse regimen over 6 months), while Group B will use ketoconazole shampoo (initial daily use followed by twice weekly application). Outcomes will be assessed using the Scalp Seborrheic Dermatitis (SSD) score, Clinical Global Impression (CGI) scale, and Patient Global Impression (PGI) scale. The study aims to compare: Treatment effectiveness Frequency of disease relapses Patient satisfaction Side-effect profiles Data will be analyzed using statistical tests (t-tests and chi-square), with significance set at p \< 0.05. The hypothesis is that oral itraconazole pulse therapy is more effective than topical ketoconazole in controlling symptoms and preventing relapses in scalp SD.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Seborrheic Dermatitis Severity Score from Baseline

Timeframe: Baseline and 4 weeks after initiation of treatment.

Trial details

NCT IDNCT07734441

SponsorCombined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-07

Contact for this trial

Bakhtawar Rehman, MBBS, FCPS Dermatology

03328883135 bakhtawar.rehman09@gmail.com

View on ClinicalTrials.gov More Seborrheic Dermatitis trials