Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Dermatology | Family Medicine
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Tazorac topical gel
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 1997
Treatment Area: psoriasis, acne vulgaris
Tazorac (tazarotene) 0.05% and 0.1% have been approved for the
treatment of stable plaque psoriasis of up to 20 % of body surface
area. The 0.1% gel has also been indicated for mild to moderately
severe facial acne vulgaris. Tazorac will be available in 30g and
Tazorac showed treatment success in up to 70% of patients with
stable plaque psoriasis when the gel was applied topically once a
day. Tazorac gel showed rapid clinical improvement in plaque
psoriasis and sustained a therapeutic effect for up to 12 weeks
after treatment. Results from more than 1,400 patients found that
up to 70% of patients with trunk limb plaque psoriasis and 60% with
knee/elbow plaque psoriasis experienced treatment success, which
was defined as good, excellent, or complete clearing of psoriasis.
For treatment of common acne, the 0.1% gel demonstrated good to
excellent efficacy in up to 70% of patients.
Tazorac has a well documented safety profile and is safe to use
on most parts of the body including the face and scalp. The most
frequently reported side effects consist of local irritation
including itching, burning, stinging and erythema. Side effects
were reported mild-to-moderate and dose related.
Mechanism of Action
Tazorac is a receptor-selective retinoid. The gel is thought to
normalize epidermal differentiation, reducing the influx of
inflammatory cells into the skin. Its topical delivery targets the
skin where these processes occur. Synthetic retinoids are vitamin A
analogs and are thought to play a role in skin cell differentiation
The aqueous topical gel is compatible with moisturizers and
cosmetics. Psoriasis has been treated by oral retinoids but their
side effects limited use to patients with severe disease. Other,
earlier topical retinoids had been used to treat acne but had shown
poor efficacy with psoriasis. Tazorac gel has been marketed outside
the U.S. under the brand name Zorac.