"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directed compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials on the Scalp
The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 g. Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:
Table 1 : Number and Percentage with Adverse Reactions
in Scalp Psoriasis Trials (Events Reported by ≥ 1% of Subjects and for
Which a Relationship is Possible)
|Taclonex® Topical Suspension
|Betamethasone dipropionate in vehicle
|Calcipotriene in vehicle
|Event||# of subjects (%)|
|Folliculitis||16 (1%)||12 (1%)||5 (1%)||0 (0%)|
|Burning sensation of skin||13 (1%)||10 (1%)||29 (3%)||0 (0%)|
Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week trial, adverse reactions that were reported by > 1% of subjects treated with Taclonex® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%).
Clinical Trials on the Body
In randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in subjects with plaque psoriasis on non-scalp areas, subjects applied study product once daily for 8 weeks. A total of 824 subjects were treated with Taclonex® Topical Suspension and the median weekly dose was 22.6 g. There were no adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle.
Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: rash and folliculitis.
Read the Taclonex Scalp (calcipotriene and betamethasone dipropionate topical suspension) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 8/11/2014
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