ADVERSE REACTIONS
In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.
Two clinical studies compared once- to twice-daily administration of CUTIVATE Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1. In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.
Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. CUTIVATE Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were
Table 1. Drug-Related Adverse Events--Skin
|
Adverse Events
|
Fluticasone Once Daily
(n = 210) |
Fluticasone Twice Daily
(n = 203) |
Vehicle Twice Daily
(n = 78)
|
|
Skin infection
|
1 (0.5%) |
0 |
0 |
|
Infected eczema
|
1 (0.5%) |
2 (1.0%) |
0 |
|
Viral warts
|
0 |
1 (0.5%) |
0 |
|
Herpes simplex
|
0 |
1 (0.5%) |
0 |
|
Impetigo
|
1 (0.5%) |
0 |
0 |
|
Atopic dermatitis
|
1 (0.5%) |
0 |
0 |
|
Eczema
|
1 (0.5%) |
0 |
0 |
|
Exacerbation of eczema
|
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
|
Erythema
|
0 |
2 (1.0%) |
0 |
|
Burning
|
2 (1.0%) |
2 (1.0%) |
2 (2.6%) |
|
Stinging
|
0 |
2 (1.0%) |
1 (1.3%) |
|
Skin irritation
|
6 (2.9%) |
2 (1.0%) |
0 |
|
Pruritus
|
2 (1.0%) |
4 (1.9%) |
4 (5.1%) |
|
Exacerbation of pruritus
|
4 (1.9%) |
1 (0.5%) |
1 (1.3%) |
|
Folliculitis
|
1 (0.5%) |
1 (0.5%) |
0 |
|
Blisters
|
0 |
1 (0.5%) |
0 |
|
Dryness of skin
|
3 (1.4%) |
1 (0.5%) |
0 |
|
Table 2. Adverse Events * From Pediatric Open-Label Trial (n = 51)
|
Adverse Events
|
Fluticasone Twice Daily
|
|
Burning
|
1 (2.0%) |
|
Dusky erythema
|
1 (2.0%) |
|
Erythematous rash
|
1 (2.0%) |
|
Facial telangiectasia **/* |
2 (4.9%) |
|
Non-facial telangiectasia
|
1 (2.0%) |
|
Urticaria
|
1 (2.0%) |
|
*See text for additional detail. |
| **/* n = 41.
|
|
The following local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.
|
