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Azelaic Acid Cream
Azelaic acid reduces bacterial colonization and normalizes keratinization to treat inflammatory skin conditions.
Azelaic acid reduces bacterial colonization and normalizes keratinization to treat inflammatory skin conditions. Used for Rosacea, Acne vulgaris, Post-inflammatory hyperpigmentation.
At a glance
| Generic name | Azelaic Acid Cream |
|---|---|
| Also known as | Finacea Gel |
| Sponsor | LEO Pharma |
| Drug class | Topical antimicrobial and anti-inflammatory agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Azelaic acid exerts antimicrobial effects against Propionibacterium acnes and has anti-inflammatory properties that reduce follicular hyperkeratinization. It also inhibits melanin synthesis, making it useful for post-inflammatory hyperpigmentation. The exact molecular targets are not fully characterized but involve multiple pathways affecting bacterial growth, inflammation, and pigmentation.
Approved indications
- Rosacea
- Acne vulgaris
- Post-inflammatory hyperpigmentation
Common side effects
- Pruritus
- Burning sensation
- Erythema
- Xerosis
Key clinical trials
- Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma (NA)
- Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne (PHASE4)
- Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma (PHASE1)
- Efficacy of Melanostop Peeling for Improvement of Melasma (NA)
- Phase 3 Papulopustular Rosacea Study (PHASE3)
- Phase 3 Papulopustular Rosacea Study (PHASE3)
- Preferences & Treatment Satisfaction Drivers in Rosacea Patients
- Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris (PHASE4)
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:
- Azelaic Acid Cream CI brief — competitive landscape report
- Azelaic Acid Cream updates RSS · CI watch RSS
- LEO Pharma portfolio CI