Derma-Smoothe FS
(fluocinolone acetonide)Derma-Smoothe FS Prescribing Information
Derma-Smoothe/FS® is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
Derma-Smoothe/FS® for scalp psoriasis in adults (Scalp Oil):
For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Derma-Smoothe/FS® on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
Derma-Smoothe/FS® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
This product contains refined peanut oil NF (see PRECAUTIONS section).
The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Derma-Smoothe/FS®.
A post marketing (open-label) safety study was conducted in 58 children to evaluate the local safety of Derma-Smoothe/FS® when applied twice daily for 4 weeks to the face in children (2 to 12 years) with moderate to severe atopic dermatitis (see Table of Incidence of Adverse Events).
| Adverse Event (AE) * | # of patients (%) | Day 14 | Day 28 † | Day 56 ‡ |
| ||||
| Any AE | 15 (25.9) | 6 (10.3) | 7 (12.1) | 7 (12.1) |
| Telangiectasia | 5 (8.6) | 3 (5.2) | 4 (6.9) | 2 (3.5) |
| Erythema | 3 (5.2) | 3 (5.2) | ||
| Itching | 3 (5.2) | 3 (5.2) | ||
| Irritation | 3 (5.2) | 3 (5.2) | ||
| Burning | 3 (5.2) | 3 (5.2) | ||
| Hypopigmentation | 2 (3.5) | 2 (3.5) | ||
| Shiny Skin | 1 (1.7) | 1 (1.7) | ||
| Secondary atopic dermatitis | 1 (1.7) | 1 (1.7) | ||
| Papules and pustules | 1 (1.7) | 1 (1.7) | ||
| Keratosis pilaris | 1 (1.7) | 1 (1.7) | ||
| Folliculitis | 1 (1.7) | 1 (1.7) | ||
| Facial herpes simplex | 1 (1.7) | 1 (1.7) | ||
| Acneiform eruption | 1 (1.7) | 1 (1.7) | ||
| Ear infection | 1 (1.7) | 1 (1.7) | ||
Derma-Smoothe/FSTopical® Oil contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Derma-Smoothe/FS® 0.01% fluocinolone acetonide for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:
Fluocinolone acetonide in Derma-Smoothe/FS® has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of Derma-Smoothe/FS® contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances .
Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.
Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics:
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusion of topical corticosteroids can enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Also, inflammation and/or other disease processes in the skin can increase percutaneous absorption.
Derma-Smoothe/FS® is in the low to medium range of potency as compared with other topical corticosteroids.
CLINICAL STUDIES
In a vehicle-controlled study for the treatment of psoriasis of the scalp in adults, after 21 days of treatment, 60% of patients on active treatment and 21% of patients on the drug vehicle had excellent to cleared clinical response.
Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Derma-Smoothe/FS® twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at 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 ug/dL; normal: cortisol > 7 ug/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 ug/dL).
A clinical study was conducted to assess the safety of Derma-Smoothe/FS®, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing refined peanut oil NF, Derma-Smoothe/FS® and histamine/saline controls, on the 13 individuals. These subjects were also treated with Derma-Smoothe/FS® twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS® 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® use. Importantly, the bulk peanut oil NF, used in Derma-Smoothe/FS® is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.
CLINICAL STUDIES
In a vehicle-controlled study for the treatment of psoriasis of the scalp in adults, after 21 days of treatment, 60% of patients on active treatment and 21% of patients on the drug vehicle had excellent to cleared clinical response.
Open-label safety studies on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis, and baseline body surface area involvement greater than 75% in 18 patients, and 50% to 75% in 15 patients, were treated with Derma-Smoothe/FS® twice daily for 4 weeks. Morning pre-stimulation cortisol level and post-Cortrosyn stimulation cortisol level were obtained in each subject at 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 ug/dL; normal: cortisol > 7 ug/dL) but all had normal responses to 0.25 mg of Cortrosyn stimulation (cortisol > 18 ug/dL).
A clinical study was conducted to assess the safety of Derma-Smoothe/FS®, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 patients with atopic dermatitis, 6 to 17 years of age. Of the 13 patients, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the responses to both prick test and patch test utilizing refined peanut oil NF, Derma-Smoothe/FS® and histamine/saline controls, on the 13 individuals. These subjects were also treated with Derma-Smoothe/FS® twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to Derma-Smoothe/FS® 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® use. Importantly, the bulk peanut oil NF, used in Derma-Smoothe/FS® is heated at 475° F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins.
Derma-Smoothe/FS® is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC # 68791-102-04).
Scalp Oil is supplied with 2 shower caps.
Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature].
CAUTION: Rx only
Manufactured by:
Hill Dermaceuticals, Inc.®
Sanford, FL 32773
1.800.344.5707
For: Royal Pharmaceuticals, Inc
Manasquan, NJ 08736
1.800.510.3401
Rev. CODE 171A239-1
Date: 1/2014