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 |
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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 | |