Safe and Well-Tolerated in Patients

as Young as 2 Years~~Old~~,

Suitable for Sensitive Skin

Safety Overview
In the 8-week Phase III randomized controlled study, adverse events occurred in 51.4% of the tapinarof group and 43.2% of the placebo group; most were mild to moderate.
Adverse Events
Zedman® (N=183)
Placebo (N=88)
Patients with Adverse Events
94(51.4)
38(43.2)
Discontinuation due to Adverse Events
8(4.4)
3(3.4)
Grade 3–5 Adverse Events
8(4.4)
3(3.4)
Death due to Adverse Events
0(0.0)
0(0.0)
Most Common Adverse Events
Application Site Reactions*
16(8.7)
1(1.1)
Folliculitis†
14 (7.7)
4(4.5)
Contact Dermatitis‡
9(4.9)
4(4.5)
Cough
2(1.1)
4(4.5)
Headache
3(1.6))
0(0)
Safe and well-tolerated, even on sensitive skin, with no application site restrictions.
Local tolerability scores indicate minimal to no irritation, even on sensitive areas such as the face, neck, and skin folds.
Safety Features
⚠ No Black Box Warning or contraindications
No Black Box Warning or contraindications
No application restrictions per package insert; can be used on all affected skin areas
Negligible to no systemic absorption
Tolerability Features
No stinging or burning sensation based on local tolerability scores.
Important Safety Information
Indication: Zedman® (Tapinarof Cream, concentration/strength per package insert)is a drug with an aryl hydrocarbon receptor (AhR)-related mechanism of action. It is indicated for the topical treatment of patients aged 2 years and older.
*Observed adverse events (% placebo-adjusted): application site reactions (7.6%), folliculitis (3.2%), contact dermatitis (0.4%), headache (1.6%).