Derma-Smoothe/FS Prescribing Information

DERMA-SMOOTHE/FS® Scalp Oil is indicated for the treatment of psoriasis of the scalp in adults.

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.

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:

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

8.2 Lactation

8.4 Pediatric Use

12.1 Mechanism of Action

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.

12.2 Pharmacodynamics

Vasoconstrictor Assay
DERMA-SMOOTHE/FS Scalp Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression
HPA axis suppression following administration of DERMA-SMOOTHE/FS Scalp Oil was not assessed.

12.3 Pharmacokinetics

Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

13.1 Carcinogenesis, mutagenesis, impairment of fertility

No carcinogenicity, genotoxicity, or fertility studies were conducted with DERMA-SMOOTHE/FS Scalp Oil. However, some corticosteroids are genotoxic in various genotoxicity tests (i.e., the in vitro human peripheral blood lymphocyte chromosome aberration assay with metabolic activation, the in vivo mouse bone marrow micronucleus assay, the Chinese hamster micronucleus test, and the in vitro mouse lymphoma gene mutation assay).

Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Administration Instructions
Advise patients that DERMA-SMOOTHE/FS Scalp Oil is for topical use only [see Dosage and Administration (2)].

Instruct patients not to apply DERMA-SMOOTHE/FS Scalp Oil to the diaper area as diapers or plastic pants may constitute occlusive use [see Dosage and Administration (2)].

Advise patients to avoid use of DERMA-SMOOTHE/FS Scalp Oil on the face, axillae, or groin unless directed by their healthcare provider [see Dosage and Administration (2)].

Advise patients to discontinue therapy when control of disease is achieved. Instruct patients to contact their healthcare provider if no improvement is seen within 2 weeks [see Dosage and Administration (2)].

Endocrine System Adverse Reactions
Instruct patients not to use other corticosteroid-containing products while using DERMA-SMOOTHE/FS Scalp Oil without first consulting their healthcare provider [see Warnings and Precautions (5.1)].

Ophthalmic Adverse Reactions
Advise patients to avoid contact with the eyes and in case of contact, wash eyes liberally with water. Instruct patients to tell their healthcare provider if they develop any visual symptoms [see Warnings and Precautions (5.3)].

Pregnancy and Lactation
Advise women to use DERMA-SMOOTHE/FS Scalp Oil on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise patients that are breastfeeding not to apply DERMA-SMOOTHE/FS Scalp Oil directly to the nipple and areola to avoid direct infant exposure [See Use in Specific Populations (8.1 and 8.2)].