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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active-controlled clinical studies 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 Scalp® (calcipotriene and betamethasone dipropionate topical suspension) Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:
Table 1
| Number and Percentage of Patients with Adverse Reactions in Scalp Psoriasis Studies (Events Reported by ≥ 1% of Subjects and for Which a Relationship is Possible)* | ||||
| Taclonex Scalp® Topical Suspension N=1,953 |
Betamethasone dipropionate in vehicle N=1,214 |
Calcipotriene in vehicle N=979 |
Vehicle N=173 |
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| Event | # of subjects (%) | |||
| Folliculitis | 16 (1%) | 12 (1%) | 5 (1%) | 0 (0%) |
| Burning sensation of skin | 13 (1%) | 10 (1%) | 29 (3%) | 0 (0.0%) |
| * Adverse reactions reported at a rate higher than vehicle. | ||||
Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with Taclonex Scalp® (calcipotriene and betamethasone dipropionate topical suspension) Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). The effects of Taclonex Scalp® (calcipotriene and betamethasone dipropionate topical suspension) Topical Suspension on calcium metabolism and the HPA axis were not investigated in the 52-week study.
No information provided.
Last reviewed on RxList: 6/18/2008
This monograph has been modified to include the generic and brand name in many instances.
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