Comparing two medicines (Itraconazole and Isotretinion) in treating seborrheic dermatitis

Comparison of the effect of low-dose oral Isotretinoin and Itraconazole on symptoms in seborrheic dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000021370

Enrollment

Registered

2026-01-07

Start date

2025-07-01

Completion date

2025-09-30

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study design: Randomised control trial Intervention Description: A comparative study of low-dose oral Isotretinoin 20 mg/day twice weekly for three consecutive months and Itraconazole 200 mg/day during the 1st week of the 1st month, then 200 mg daily on 1st two days of every month for next two months in moderate to severe seborrheic dermatitis conducting at dermatology out-patient department PNS Shifa hospital ,Karachi. After written consent 68 patients are divided into Group A and B. Patients in both the groups will receive treatment for 3 months and data from the patients will be collected through a proforma on first visit and follow ups. Evaluation will be done through SDASI score at baseline, 4 weeks, 8 weeks and 12 weeks after commencement of treatment Outcomes will be assessed as: o Complete Resolution (90% Decrease or more of SDASI Score from Baseline) o Partial Improvement (25-90% Decrease in SDASI Score from Baseline) o No Improvement (< 25% Decrease in SDASI Score from Baseline) HYPOTHESIS: Proposition of this study is based on the belief that low dose oral isotretinoin has similar efficacy and safety to itraconazole for treatment of seborrheic dermatitis

Interventions

Group A: Low-Dose Oral Isotretinoin (20 mg/day twice weekly for three consecutive months)

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

• Both Genders • Adults aged 18–70 years. • Clinical assessment using the SDASI (Seborrheic Dermatitis Area Severity Index),of moderate to severe Seborrheic dermatitis (a score of 4 and above). • Agreeing to follow the instructions given in the course of the study and show up for follow-up examinations. • Patients not taking any topical medication for Seborrheic Dermatitis for the last two months

Exclusion criteria

• Pregnant or breastfeeding women. • Current use of systemic antifungals, or isotretinoin within the past half a year. • Patients with any history of Hyperlipidemia, severe hepatic, renal or cardiac disease. • Patients known to be hypersensitive to isotretinoin and itraconazole. • Patients with uncontrolled Diabetes Mellitus, Malnourished, children or those receiving systemic immunosuppressants. • Patients having mild Seborrheic Dermatitis

Outcome results