Source: FDA, National Drug Code (US) Revision Year: 2020
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.
The contribution to efficacy by individual components of the vehicle has not been established.
In an HPA axis suppression trial, three of 75 (4%) pediatric subjects with mild to moderate atopic dermatitis covering at least 25% body surface area, who applied VERDESO Foam twice daily, experienced reversible suppression of the adrenal glands (as indicated by a 30-minute post-stimulation cortisol level 18 mcg/dL) following 4 weeks of therapy [See also Hypothalamic-Pituitary-Adrenal Axis Suppression (5.1) and Pediatric Use (8.4)].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation, the integrity of the epidermal barrier, and age. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of VERDESO Foam or desonide.
In a 90-day repeat-dose toxicity study in rats, topical administration of VERDESO Foam at dose concentrations from 0.025% to 0.125% (providing 0.075 to 0.375 mg/kg/day of desonide) resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.
Desonide revealed no evidence of mutagenic potential based on the results of 2 in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).
The effects of desonide on fertility have not been evaluated.
In a double-blind, randomized trial of 581 subjects aged 3 months to 17 years, with mild to moderate atopic dermatitis, VERDESO Foam was applied twice daily for 4 weeks. Success was defined as the proportion of subjects who had all of the following: an Investigator’s Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the 5-point ISGA score of 2 grades from Baseline to Week 4, and a score of absent or minimal for both erythema and induration/papulation at Week 4. The results of this trial are presented in the following table.
Table 2. Results of Clinical Trial in Subjects Aged 3 Months to 17 Years With Mild to Moderate Atopic Dermatitis:
| VERDESO Foam | Vehicle Foam | |
|---|---|---|
| Number of Patients | 387 | 194 |
| Patients Achieving Success | 152 (39%) | 18 (9%) |
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