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ACZONE Gel, 5%
Dapsone reduces inflammation and bacterial colonization in acne lesions through its antimicrobial and anti-inflammatory properties.
Dapsone reduces inflammation and bacterial colonization in acne lesions through its antimicrobial and anti-inflammatory properties. Used for Acne vulgaris.
At a glance
| Generic name | ACZONE Gel, 5% |
|---|---|
| Sponsor | Allergan |
| Drug class | Sulfone antibiotic |
| Target | Bacterial dihydropteroate synthase; neutrophil-mediated inflammation |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Dapsone is a sulfone antibiotic that exhibits both bacteriostatic activity against Cutibacterium acnes and direct anti-inflammatory effects by suppressing neutrophil function and reducing inflammatory mediators. When applied topically as a 5% gel, it penetrates the skin to reduce acne-related inflammation and bacterial load while minimizing systemic absorption.
Approved indications
- Acne vulgaris
Common side effects
- Oiliness/greasiness at application site
- Erythema
- Dryness
- Peeling
Key clinical trials
- Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris (PHASE2)
- Effect of New Topical Preparation for Treatment of Acne Vulgaris (PHASE2)
- Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris (PHASE1)
- Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis (PHASE4)
- Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications (PHASE4)
- Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris (PHASE1)
- Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT (PHASE3)
- Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris (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:
- ACZONE Gel, 5% CI brief — competitive landscape report
- ACZONE Gel, 5% updates RSS · CI watch RSS
- Allergan portfolio CI