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Ketoconazole 2% Shampoo
Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in fungal cell membranes and causing cell death.
Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in fungal cell membranes and causing cell death. Used for Seborrheic dermatitis of the scalp, Dandruff, Tinea versicolor (pityriasis versicolor).
At a glance
| Generic name | Ketoconazole 2% Shampoo |
|---|---|
| Also known as | Nizoral |
| Sponsor | Fakultas Kedokteran Universitas Indonesia |
| Drug class | Imidazole antifungal |
| Target | Fungal cytochrome P450 (CYP51 / lanosterol 14α-demethylase) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Ketoconazole is an imidazole antifungal that blocks the fungal enzyme lanosterol 14α-demethylase (CYP51), a key step in ergosterol biosynthesis. This disrupts the integrity of the fungal cell membrane, leading to leakage of cellular contents and fungal cell death. The 2% shampoo formulation delivers the drug topically to the scalp for local antifungal activity.
Approved indications
- Seborrheic dermatitis of the scalp
- Dandruff
- Tinea versicolor (pityriasis versicolor)
- Malassezia-related scalp conditions
Common side effects
- Scalp irritation
- Dryness
- Pruritus
- Contact dermatitis
Key clinical trials
- Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor (PHASE4)
- 8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor (PHASE4)
- A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. (PHASE1)
- To Evaluate the Efficacy and Safety of Shampoo TD03 and TD07 in Scalp Diseases (PHASE3)
- Effects on the Scalp Microbiota of a 1% Selenium Disulfide and 1% Salicylic Acid Shampoo After 2% Ketaconazole Foaming Gel Treatment for Scalp Seborrheic Dermatitis (NA)
- Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis (PHASE3)
- The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial (PHASE4)
- Seborrheic Dermatitis: Ketoconazole 2% Foam Versus Ketoconazole 2% Shampoo (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ketoconazole 2% Shampoo CI brief — competitive landscape report
- Ketoconazole 2% Shampoo updates RSS · CI watch RSS
- Fakultas Kedokteran Universitas Indonesia portfolio CI