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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 (%)
N=58

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 (%)
N=30*

Adverse Reaction # of subjects (%)
Diarrhea 1 (3)
Vomiting 1 (3)
Pyrexia 3 (10)
Abscess 1 (3)
Molluscum 1 (3)
Nasopharyngitis 2 (7)
URI 1 (3)
Otitis media 1 (3)
Cough 6 (20)
Rhinorrhea 4 (13)
Atopic dermatitis 1 (3)
Eczema 1 (3)
Hyperpigmentation 1 (3)
Hypopigmentation 2 (7)
Rash 1 (3)
*Includes one subject who withdrew at Week 2