Company:

Medicis

Topical antibiotic (lincosamide) + retinoid

Clindamycin phosphate 1.2%; tretinoin 0.025%; gel.

Acne vulgaris.

Ziana is a topical gel for acne that combines clindamycin and tretinoin. Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis. It has been shown to have in vitro activity against P. acnes. Tretinoin is a retinoid that has been shown to reduce microcomedo formation. It also reduces the cohesiveness and increases the turnover of follicular epithelial cells, causing extrusion of the comedones.

Three 12-week, prospective, randomized blinded studies, each involving over 1,000 patients, were conducted to assess the safety and efficacy of Ziana in the treatment of acne. In the first two studies, this combination product was compared to clindamycin in the vehicle gel, tretinoin in the vehicle gel, and the vehicle gel alone in treating patients with mild, moderate, or severe acne vulgaris. The combined results of Study 1 and Study 2 showed that 21% of the patients using Ziana were evaluated as experiencing “success” (cleared or almost cleared) at 12 weeks, compared to 8% for those using the vehicle alone. For those using clindamycin alone, 16% achieved “success”, and for those using tretinoin alone, 14% of the patients achieved “success”. The percent reduction from baseline in mean total (inflammatory + non-inflammatory) lesion count was 41% for the Ziana-treated patients, compared to 20% for the vehicle alone, 34% for both clindamycin and for tretinoin alone. Local side effects (eg, erythema, scaling, itching burning, and sting-ing) peaked at 2 weeks and then decreased.

In Study 3, the use of Ziana was compared to clindamycin gel in more than 2,000 patients with moderate or severe acne vulgaris. In this study, “success” was assessed by the percentage of patients who had at least 2 grades of improvement from baseline to week 12. For those patients using Ziana, 41% achieved “success,” compared to 34% for those patients using clindamycin gel. In the group of patients using Ziana, there was a 54% reduction from baseline in total lesion count compared to 47% in the clindamycin-treated group.

Apply thin film to clean, dry face once daily at bedtime.

Not recommended.

Regional enteritis. Ulcerative colitis. History of antibiotic-associated colitis.

Sunburn (allow to heal before using). Avoid sun, UV light (use sunscreen and adequate sun protection daily). Avoid eyes, mouth, angles of nose, mucous membranes. Discontinue if significant diarrhea occurs. Increased irritation in extreme weather. Pregnancy (Cat.C). Nursing mothers: not recommended.

Avoid erythromycin. Additive irritation with other topical products (eg, alcohol, drying agents, lime). May potentiate neuromuscular blockers. Caution with other photosensitizers (eg, tetracyclines, quinolones).

Erythema, scaling, itching, burning, stinging, nasopharyngitis, throat pain, dry skin, cough, sinusitis; rare: diarrhea, colitis.

Gel—2g, 30g, 60g

1/5/07