Last reviewed · How we verify
Aczone 5% gel
Dapsone reduces inflammation and bacterial growth in acne lesions through antimicrobial and anti-inflammatory effects.
Dapsone reduces inflammation and bacterial growth in acne lesions through antimicrobial and anti-inflammatory effects. Used for Acne vulgaris.
At a glance
| Generic name | Aczone 5% gel |
|---|---|
| Also known as | Dapsone, dapsone |
| Sponsor | Derm Research, PLLC |
| Drug class | Sulfone antimicrobial agent |
| Target | Bacterial dihydropteroate synthase; anti-inflammatory mechanisms |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Dapsone is a sulfone antimicrobial agent that inhibits bacterial protein synthesis and has potent anti-inflammatory properties, particularly effective against Cutibacterium acnes (formerly Propionibacterium acnes). When applied topically as a 5% gel, it reduces both the bacterial load and inflammatory response in acne-prone skin, making it useful for patients with acne vulgaris, particularly those with inflammatory lesions.
Approved indications
- Acne vulgaris
Common side effects
- Oiliness or dryness at application site
- Erythema
- Peeling or desquamation
- Contact dermatitis
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 5% gel CI brief — competitive landscape report
- Aczone 5% gel updates RSS · CI watch RSS
- Derm Research, PLLC portfolio CI