MedTrace Logo

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

NCT07734441 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-29

No results posted yet for this study

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

Interventions

DRUG

Itraconazole (200 mg)

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

DRUG

Ketoconazole 2%

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-07
Primary Completion
2026-09-07
Completion
2026-09-07

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734441 on ClinicalTrials.gov