For Physicians
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 Lesions
1,6
Studies 1 and 2, Combined*
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, Combined
1,7
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 Lesions
1,6
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 3
1,7
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.
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Medicis Customer Service Representatives are available to answer your
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| Email: | customer_service@Medicis.com |
| Medicis Customer Service: |
1-800-550-5115 |
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Medicis, The Dermatology Company
7720 North Dobson Road
Scottsdale, AZ 85256-2740 |
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