Fluocinolone Acetonide

Derma-Smoothe/FS ® Scalp Oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 ) DERMA-SMOOTHE/FS ® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.

DERMA-SMOOTHE/FS Scalp Oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps. DERMA-SMOOTHE/FS Scalp Oil is a topical oil containing 0.01% fluocinolone acetonide, supplied in bottles containing 4 fluid ounces and with 2 shower caps. ( 3 )

None. None. ( 4 )

Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Potent corticosteroids use on large areas, prolonged use or occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption. Modify use should HPA axis suppression develop. ( 5.1 ) Local Adverse Reactions: Local adverse reactions may include atrophy, striae irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis, and may be more likely with occlusive use or more potent corticosteroids. ( 5.2 , 6.1 ) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of DERMA-SMOOTHE/FS Scalp Oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 )

5.1 Endocrine System Adverse Reactions Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing's syndrome have been reported in patients receiving topical corticosteroids. Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

5.2 Local Adverse Reactions Local adverse reactions may occur with use of topical corticosteroids, including Derma-Smoothe/FS Scalp Oil, and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria [see Adverse Reactions (6.1) ] .

5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of DERMA-SMOOTHE/FS Scalp Oil with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.4 Allergic Contact Dermatitis Use of topical corticosteroids can cause allergic contact dermatitis. Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.5 Concomitant Skin Infections Use of topical corticosteroids may delay healing or worsen concomitant skin infections. Treat concomitant skin infections with an appropriate antimicrobial agent. If the infection persists unchanged, discontinue DERMA-SMOOTHE/FS Scalp Oil until the infection has been adequately treated.

5.6 Use in Peanut-Sensitive Individuals Use caution in prescribing DERMA-SMOOTHE/FS Scalp Oil for peanut-sensitive individuals [see Description (11) ] . Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, discontinue DERMA-SMOOTHE/FS Scalp Oil immediately and institute appropriate therapy.

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

• Endocrine System Adverse Reactions [see Warnings and Precautions (5.1) ]
• Local Adverse Reactions [see Warnings and Precautions (5.2) ]
• Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc. at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying condition, 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. An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of DERMA-SMOOTHE/FS Scalp Oil twice daily for 4 weeks. DERMA-SMOOTHE/FS Scalp Oil is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study: Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of DERMA-SMOOTHE/FS Scalp Oil, N=30 Includes one subject who withdrew at Week 2 Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3)

6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema

8.1 Pregnancy Risk Summary Available data from case reports, case series, and observational studies on fluocinolone acetonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Observational studies suggest maternal use of high to super-high potency topical steroids may be associated with an increased risk of low birthweight infants. Advise pregnant women to use DERMA-SMOOTHE/FS Scalp Oil on the smallest area of skin and for the shortest duration possible. Corticosteroids can cause fetal malformations in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids cause fetal malformations after dermal application in laboratory animals. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2 Lactation Risk Summary There is no information regarding the presence of fluocinolone acetonide in breast milk or its effects on the breastfed infant or on milk production. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. To minimize potential exposure to the breastfed infant via breast milk, use DERMA-SMOOTHE/FS Scalp Oil on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply DERMA-SMOOTHE/FS Scalp Oil directly to the nipple and areola to avoid direct infant exposure [see Warnings and Precautions (5.1) ] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DERMA-SMOOTHE/FS Scalp Oil and any potential adverse effects on the breastfed infant from DERMA-SMOOTHE/FS Scalp Oil or from the underlying maternal condition.

8.4 Pediatric Use The safety and effectiveness of DERMA-SMOOTHE/FS Scalp Oil have not been established in pediatric patients with psoriasis of the scalp. Evaluation in Peanut-Sensitive Pediatric Patients A clinical trial was conducted to assess the safety of the formulation of DERMA-SMOOTHE/FS Scalp Oil, which contains refined peanut oil, in patients with known peanut allergies. The trial enrolled 13 pediatric subjects with atopic dermatitis, 6 to 17 years of age. DERMA-SMOOTHE/FS Scalp Oil is not approved for the treatment of atopic dermatitis. 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, the formulation of DERMA-SMOOTHE/FS Scalp Oil and histamine/saline controls. Subjects were also treated with the formulation of DERMA-SMOOTHE/FS Scalp Oil twice daily for 7 days. Prick test and patch test results for all 13 subjects were negative to the formulation of DERMA-SMOOTHE/FS Scalp Oil and the refined peanut oil. One of the 9 peanut-sensitive subjects experienced an exacerbation of atopic dermatitis after 5 days of use on the formulation of DERMA-SMOOTHE/FS Scalp Oil.

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in psoriasis of the scalp is unknown.