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azelaic acid 15% gel
Azelaic acid reduces bacterial colonization and normalizes keratinization while exerting anti-inflammatory and antimicrobial effects on the skin.
Azelaic acid reduces bacterial colonization and normalizes keratinization while exerting anti-inflammatory and antimicrobial effects on the skin. Used for Acne vulgaris, Rosacea, Post-inflammatory hyperpigmentation.
At a glance
| Generic name | azelaic acid 15% gel |
|---|---|
| Also known as | Finacea® 15% Gel, Finacea, Finacea® gel 15% |
| Sponsor | Galderma R&D |
| Drug class | Topical antimicrobial and anti-inflammatory agent |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Azelaic acid works through multiple mechanisms: it inhibits the growth of Cutibacterium acnes and Staphylococcus epidermidis, reduces the production of inflammatory mediators, and normalizes follicular keratinization. It also has tyrosinase-inhibiting properties that help reduce hyperpigmentation. These combined effects make it effective for treating acne and rosacea by addressing both bacterial and inflammatory components of the disease.
Approved indications
- Acne vulgaris
- Rosacea
- Post-inflammatory hyperpigmentation
Common side effects
- Pruritus
- Erythema
- Burning sensation
- Scaling
Key clinical trials
- Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne (PHASE4)
- To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel (PHASE1)
- A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily (PHASE4)
- A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face (PHASE2)
- A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis (PHASE2)
- Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne (PHASE3)
- Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea (PHASE1)
- Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea (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
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