"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...
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.
Clinical Studies Experience: Evaluation of Facial Use in Pediatric Subjects
An, open-label, study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of Derma-Smoothe/FS® (fluocinolone acetonide) when applied to the face twice daily for 4 weeks. The following adverse reactions were reported:
Incidence of Adverse Reactions (%)
|Adverse Reaction (AR)*|| # of subjects
|Day 14||Day 28**||Day 56***|
|Any AE||15 (26)||6 (10)||7 (12)||7 (12)|
|Telangiectasia||5 (9)||3 (5)||4 (7)||2 (4)|
|Erythema||3 (5)||3 (5)|
|Itching||3 (5)||3 (5)|
|Irritation||3 (5)||3 (5)|
|Burning||3 (5)||3 (5)|
|Hypopigmentation||2 (4)||2 (4)|
|Shiny skin||1 (2)||1 (2)|
|Secondary atopic dermatitis||1 (2)||1 (2)|
|Papules and pustules||1 (2)||1 (2)|
|Keratosis pilaris||1 (2)||1 (2)|
|Folliculitis||1 (2)||1 (2)|
|Facial herpes simplex||1 (2)||1 (2)|
|Acneiform eruption||1 (2)||1 (2)|
|Ear infection||1 (2)||1 (2)|
| *The number of individual adverse reactions reported does
not necessarily reflect the number of individual subjects, since one subject
could have multiple reporting of an adverse reaction.
**End of Treatment
***Four Weeks Post Treatment
Clinical Studies Experience: Evaluation in Pediatric Subjects 3 months to 2 years old
An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of Derma-Smoothe/FS (fluocinolone acetonide) twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations]:
Adverse Reactions (%)
|Adverse Reaction||# of subjects (%)|
|Otitis media||1 (3)|
|Atopic dermatitis||1 (3)|
|*Includes one subject who withdrew at Week 2|
Read the Derma-Smoothe/FS (fluocinolone acetonide) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 1/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Derma-Smoothe/FS Information
Derma-Smoothe/FS - User Reviews
Derma-Smoothe/FS User Reviews
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