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Topical ketoconazole 2% cream
Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death.
Ketoconazole inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death. Used for Tinea corporis (ringworm of the body), Tinea cruris (jock itch), Tinea pedis (athlete's foot).
At a glance
| Generic name | Topical ketoconazole 2% cream |
|---|---|
| Sponsor | PAEC General Hospital, Islamabad |
| Drug class | Imidazole antifungal |
| Target | Fungal cytochrome P450 (CYP51 / lanosterol 14α-demethylase) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Ketoconazole is an imidazole antifungal that blocks the demethylation of lanosterol by inhibiting fungal CYP51, a key step in ergosterol biosynthesis. This disrupts the integrity and permeability of the fungal cell membrane, leading to leakage of cellular contents and fungal cell death. The topical 2% cream formulation delivers high local concentrations to the skin while minimizing systemic absorption.
Approved indications
- Tinea corporis (ringworm of the body)
- Tinea cruris (jock itch)
- Tinea pedis (athlete's foot)
- Pityriasis versicolor
- Cutaneous candidiasis
- Seborrheic dermatitis
Common side effects
- Local irritation, burning, or stinging at application site
- Erythema or rash
- Pruritus
- Contact dermatitis
Key clinical trials
- Alternation in the Human Microbiome With Commonly Used Topical Medications (PHASE1)
- Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor. (PHASE4)
- Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne (NA)
- A Therapeutic Equivalence Study of Ketoconazole Cream 2% (PHASE3)
- Non-inferiority Trial of Dapaconazole Versus Ketoconazole (PHASE3)
- Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis (PHASE2)
- The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne (PHASE3)
- Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis (PHASE3)
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:
- Topical ketoconazole 2% cream CI brief — competitive landscape report
- Topical ketoconazole 2% cream updates RSS · CI watch RSS
- PAEC General Hospital, Islamabad portfolio CI