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Welcome

Welcome to your online resource for information about ZIANA Gel. ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

ZIANA Gel contains suspended crystalline tretinoin in a vehicle designed to deliver the active ingredients to the skin.4

The tolerability profile of ZIANA Gel has been well-documented in clinical trials with 2,295 acne patients.5 The percent of patients reporting at least one adverse event was similar among ZIANA Gel, ZIANA Gel vehicle, clindamycin phosphate 1.2% gel, and tretinoin 0.025% groups. Patients were 12 years of age and older and were treated once daily for 12 weeks.1,6

ZIANA Gel successfully reduced acne lesions.1,6 ZIANA Gel also achieved significant success in the evaluator's global severity (EGS) assessment.1,7The co-primary efficacy endpoints in these 12-week studies were: 1) mean percent change from Baseline to Week 12 in inflammatory lesion counts, noninflammatory lesion counts, and total lesion counts; and 2) either the percent of subjects who cleared or almost cleared at Week 12 [Studies 1 and 2], or the percent of subjects who had at least 2 grades of improvement from Baseline to Week 12 [Study 3], as judged by an Evaluator’s Global Severity (EGS) Score. See below for information from clinical trials.

Mean Percent Reduction in Total Lesions1,6
Studies 1 and 2, Combined*
Mean total lesion reduction, Studies 1 and 2.

• Combined analysis of two large, Phase 3, multicenter,
   randomized, blinded studies of 2,540 subjects with
   mild, moderate, or severe acne.
• p-values indicate comparison with ZIANA Gel.

Efficacy Results at Week 12
Studies 1 and 2, Combined1,7

• An EGS score of clear or almost clear at week 12 was achieved
   in significantly more patients treated with ZIANA Gel than the
   other treatment groups*:

   - 21 of 845 patients using ZIANA Gel.
   - 14 of 846 patients using tretinoin gel (p < 0.001).
   - 16 of 426 patients using clindamycin gel (p = 0.034).
   - 8 of 423 patients using gel vehicle (p < 0.001).

Mean Percent Reduction in Total Lesions1,6
Study 3*
Mean total lesion reduction, Study 3.

• Results from a Phase 3, multicenter, randomized, blinded
   study of 2,010 subjects with moderate or severe acne.
• p-values indicate comparison with ZIANA Gel.

Efficacy Results at Week 12
Study 31,7

• ZIANA Gel treatment resulted in a 2-grade EGS score improvement or better at week 12 in significantly more patients than with clindamycin gel*:

   - 41 of 1,008 patients using ZIANA Gel.
   - 34 of 1,002 patients using clindamycin gel (p < 0.001).

*All arms were studied in the same alcohol-free gel vehicle.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.

Keep away from eyes, mouth, angles of nose, and mucous membranes.

This drug is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.

Concomitant use of topical medications with a strong drying effect can increase skin irritation. Use with caution.

Contact Us

Please feel free to contact us if you have any comments or questions regarding Medicis products or this website. Medicis Customer Service Representatives are available to answer your questions via email Monday through Friday from 7 a.m. to 5 p.m. (MST).

Email:customer_service@Medicis.com
Medicis Customer Service: 1-800-550-5115
Corporate Headquarters: Medicis, The Dermatology Company
7720 North Dobson Road
Scottsdale, AZ 85256-2740

To report an adverse experience associated with one of our products, please call 800-900-6389.

Click here to view Full Prescribing Information.
Click here to view Patient Information.

Patient
Indication for ZIANA Gel

ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Important Safety Information for ZIANA Gel
  • The most commonly reported adverse events were nasopharyngitis, pharyngolaryngeal pain, dry skin, cough and sinusitis.
  • Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. ZIANA Gel should be discontinued if significant diarrhea occurs. Systemic absorption of clindamycin has been demonstrated following topical use of this product.
  • If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.
  • Avoid exposure to sunlight and sunlamps. Patients with sunburn should not use the product. Use with caution in patients who require considerable sun exposure due to occupation or who are inherently sensitive to the sun. Avoid excessive exposure to the sun, cold, and wind, which can irritate skin. Daily use of sunscreen and protective clothing are recommended.
  • Keep away from eyes, mouth, angles of nose, and mucous membranes.
  • This drug is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis.
  • Concomitant use of topical medications with a strong drying effect can increase skin irritation. Use with caution.
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