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The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FSÃ?.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FSÃ? when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see table of Incidence of Adverse Events).
Incidence of Adverse Events (%)
N=58
| Adverse Event (AE)* | # of patients (%) | Day 14 | Day 28** | Day 56*** |
| Any AE | 15 (25.9) | 6 (10.3) | 7 (12.1) | 7 (12.1) |
| Telangiectasia | 5 (8.6) | 3 (5.2) | 4 (6.9) | 2 (3.5) |
| 3 (5.2) | 3 (5.2) | |||
| Itching | 3 (5.2) | 3 (5.2) | ||
| Irritation | 3 (5.2) | 3 (5.2) | ||
| Burning | 3 (5.2) | 3 (5.2) | ||
| Hypopigmentation | 2 (3.5) | 2 (3.5) | ||
| Shiny skin | 1 (1.7) | 1 (1.7) | ||
| Secondary atopic dermatitis | 1 (1.7) | 1 (1.7) | ||
| Papules and pustules | 1 (1.7) | 1 (1.7) | ||
| 1 (1.7) | 1 (1.7) | |||
| Folliculitis | 1 (1.7) | 1 (1.7) | ||
| Facial herpes simplex | 1 (1.7) | 1 (1.7) | ||
| Acneiform eruption | 1 (1.7) | 1 (1.7) | ||
| Ear infection | 1 (1.7) | 1 (1.7) |
*The number of individual adverse events reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reportings of an adverse event.
** End of Treatment
***Four Weeks Post Treatment
No information provided.
Last reviewed on RxList: 4/18/2006
This monograph has been modified to include the generic and brand name in many instances.
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