The safety and effectiveness of DERMA-SMOOTHE/FS Body Oil for the topical treatment of moderate to severe atopic dermatitis have been established in pediatric patients aged 3 months and older for up to 4 weeks.

Safety and effectiveness of DERMA-SMOOTHE/FS Body Oil in pediatric patients with atopic dermatitis below the age of 3 months have not been established.

Systemic Adverse Reactions in Pediatric Patients   
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1)].

Evaluation in Peanut-Sensitive Pediatric Patients   
A clinical trial was conducted to assess the safety of DERMA-SMOOTHE/FS Body Oil, which contains refined peanut oil, on pediatric subjects with known peanut allergies. The study enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The trial evaluated the subjects' responses to both prick test and patch test utilizing refined peanut oil, DERMA-SMOOTHE/FS Body Oil and histamine/saline controls. Subjects were also treated with DERMA-SMOOTHE/FS Body Oil twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to DERMA-SMOOTHE/FS Body Oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of DERMA-SMOOTHE/FS Body Oil.

Evaluation in Pediatric Patients 2 to 6 years old   
Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 2 to 6 years old is supported by open-label safety trials conducted in 33 pediatric subjects (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Subjects were treated with DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2)].

Evaluation in Pediatric Patients 3 months to 2 years old   
Use of DERMA-SMOOTHE/FS Body Oil in pediatric patients 3 months to 2 years old is supported by an open-label safety trial conducted in 29 pediatric subjects (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months, and 15 subjects ages > 12 months to 2 years) to assess the HPA axis by ACTH stimulation testing following use of DERMA-SMOOTHE/FS Body Oil twice daily for 4 weeks [see Adverse Reactions (6.1)]. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 µg/dL) [see Clinical Pharmacology (12.2)].