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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.
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/21/2016
Additional Derma-Smoothe/FS Information
Derma-Smoothe/FS - User Reviews
Derma-Smoothe/FS User Reviews
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