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

NCT07734441 | Recruiting Early Phase 1 DMC

• 1 other identifier: 1595/EC/14/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seborrheic Dermatitis

Keywords

seborrheic dermatitis; scalp seborrheic dermatitis; moderate to severe disease

Outcome Measures

Primary Outcomes (1)

• Change in Seborrheic Dermatitis Severity Score from Baseline

  To compare the effectiveness of itraconazole pulse therapy versus topical 2% ketoconazole shampoo in reducing the severity of moderate to severe scalp seborrheic dermatitis using Seborrheic Dermatitis Severity Score.

  Baseline and 4 weeks after initiation of treatment.

Study Arms (2)

Oral Itraconazole pulse therapy

ACTIVE COMPARATOR

Participants receive oral itraconazole pulse therapy according to the study protocol for medrate to severe seborrheic dermatits

Drug: Itraconazole (200 mg)

Arm B : Topical 2% ketoconazole shampoo

ACTIVE COMPARATOR

Participants receive topical 2% ketoconazole shampoo according to the study protocol for moderate to severe scalp seborrheic dermatitis.

Drug: Ketoconazole 2%

Interventions

Itraconazole (200 mg) DRUG

Oral itraconazole administered as pulse therapy according to the study protocol.

Oral Itraconazole pulse therapy

Ketoconazole 2% DRUG

Ketoconazole 2% shampoo applied to the scalp twicw weekly for 4 weeks according to the study protocol.

Arm B : Topical 2% ketoconazole shampoo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan: lead

Study Sites (1)

CMH Bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Seborrheic

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Bakhtawar Rehman, MBBS, FCPS Dermatology

CONTACT

03328883135; bakhtawar.rehman09@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-04

Locations

PA (1)