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Drugs of Today (Barcelona, Spain : 1998) Jan 2008Desonide foam is a newly approved topical corticosteroid preparation of 0.05% desonide. It has been shown effective compared with vehicle placebo in the treatment of... (Review)
Review
Desonide foam is a newly approved topical corticosteroid preparation of 0.05% desonide. It has been shown effective compared with vehicle placebo in the treatment of mild-to-moderate atopic dermatitis in both pediatric and adult populations. Given the favorable safety profile of all other desonide preparations and their utility as a low potency corticosteroid, desonide foam promises to be a useful addition to the armamentarium, when other desonide vehicles might be less acceptable.
Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Inflammatory Agents; Child; Dermatitis, Atopic; Desonide; Humans; Pharmaceutical Vehicles
PubMed: 18301804
DOI: 10.1358/dot.2008.44.1.1143847 -
Expert Opinion on Investigational Drugs Jul 2008Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this... (Review)
Review
BACKGROUND
Desonide is a low-potency topical corticosteroid that has been used for decades in the treatment of steroid-responsive dermatoses. The favorable safety profile of this topical agent makes it ideal for patients of all ages.
OBJECTIVE
This article provides a review of desonide's history, pharmacodynamic properties, vehicle technology, efficacy and safety.
METHODS
Randomized controlled trials, as well as open-label and non-comparative studies, case series and reports, experimental models, and data from the Galderma pharmacovigiliance program were reviewed in order to address the clinical efficacy and safety of desonide.
RESULTS/CONCLUSION
Clinical efficacy and safety have been proven in multiple clinical trials. In addition to cream, lotion and ointment formulations, the recently developed hydrogel and foam preparations have increased desonide's versatility and patient tolerability.
Topics: Chemistry, Pharmaceutical; Desonide; Dosage Forms; Humans
PubMed: 18549345
DOI: 10.1517/13543784.17.7.1097 -
Journal of Drugs in Dermatology : JDD 2004Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper provides information on its safety... (Review)
Review
Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper provides information on its safety record, as determined from adverse event reports and published trial results. A pharmacovigilance program, initiated in 1992 for all countries where desonide is available, collected reports of adverse events associated with topical desonide over nine years. Published accounts of randomized, controlled trials of desonide in comparison with hydrocortisone were reviewed. Sixty-two reports have been collected; most were from consumers and were not medically substantiated. There were no serious reactions directly attributable to desonide treatment and the majority of events reported were classified as expected local reactions, generally mild in nature. This level of reporting is against a background of extensive prescribing of desonide; almost one million packs are dispensed per annum in the US alone. The excellent safety profile of desonide revealed by this pharmacovigilance program is supported by a review of published clinical trial results.
Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Child; Clinical Trials as Topic; Dermatitis; Dermatitis, Seborrheic; Desonide; Drug Hypersensitivity; Erythema; Eye Diseases; Humans; Ointments; Product Surveillance, Postmarketing; Randomized Controlled Trials as Topic; Skin
PubMed: 15303783
DOI: No ID Found -
Current Drug Delivery 2023When administered transdermally, desonide is ineffective due to its poor solubility. As a new transdermal delivery system, nanoemulsion gel has demonstrated significant...
BACKGROUND
When administered transdermally, desonide is ineffective due to its poor solubility. As a new transdermal delivery system, nanoemulsion gel has demonstrated significant advantages for drug delivery over conventional formulations. We have established desonide nanoemulsion gel (DES NE gel) for better transdermal absorption, but its efficacy and safety still need to be evaluated. This study aims to provide additional evidence demonstrating the improved pharmacodynamics and safety of transdermal delivery of Desonide via nanoemulsion gel.
METHODS
Pharmacodynamics and safety of Desonide nanoemulsion gel were evaluated using Desonate as the reference formulation. To assess the difference in curative effect between DES NE gel and Desonate and to ensure safety, atopic dermatitis (AD) models in KM mice were developed using 2,4-dinitrofluorobenzene (DNFB). The degree of ear swelling, ear mass difference, thymus, spleen index, and HE conventional pathology of mice were used as pharmacodynamic evaluation indexes, and the irritation was predicted by the New Zealand rabbit epidermal stimulation assay.
RESULTS
Nanoemulsion gels may facilitate transdermal penetration of drugs by influencing the skin condition. Medium and high doses of DES NE gel significantly ameliorated the inflammation and swelling of the ear caused by dermatitis/eczema in mice. In addition, compared with DES gel, skin irritation extent did not increase.
CONCLUSION
Nanoemulsion gel can be applied to improve the efficacy of drugs with low potency or poor solubility. DES NE gel provides a higher transdermal potential than other delivery systems. In this study, it was found that nanoemulsion gel is a promising percutaneous carrier of DES. DES NE-GEL has a significant curative effect on dermatitis/eczema in a mouse model and is expected to provide a new, efficient, and low toxic preparation for clinical treatment of dermatitis/eczema through the percutaneous system.
Topics: Mice; Animals; Rabbits; Skin Absorption; Skin; Desonide; Administration, Cutaneous; Eczema; Emulsions; Gels
PubMed: 35986531
DOI: 10.2174/1567201819666220819110128 -
Journal of the American Academy of... Aug 2008Desonide 0.05% was recently developed in an emulsion foam formulation.
BACKGROUND
Desonide 0.05% was recently developed in an emulsion foam formulation.
OBJECTIVE
The safety of desonide foam 0.05% in children aged 3 months to 17 years was evaluated in two phase II studies and one phase III study.
METHODS
A phase II open-label study of the effect of desonide foam 0.05% on the hypothalamic-pituitary-adrenal axis was evaluated in pediatric and adolescent participants with mild-to-moderate atopic dermatitis. The phase II and III clinical efficacy studies evaluated adverse events.
RESULTS
At the end of the 4-week treatment in the phase II study, 4% (3 of 75) of participants experienced mild, reversible hypothalamic-pituitary-adrenal-axis suppression. The combined safety data from the phase II and III studies revealed 6% of participants in the desonide foam group and 14% in the vehicle foam group reported adverse events (P = .0002), with application site burning as the most commonly reported adverse event (3% in the desonide foam group vs 7% in the vehicle foam group; P = .004).
LIMITATIONS
The studies evaluated short-term use only.
CONCLUSION
Desonide foam was safe and well tolerated in participants as young as 3 months.
Topics: Administration, Cutaneous; Adolescent; Anti-Inflammatory Agents; Child; Child, Preschool; Dermatitis, Atopic; Desonide; Drug Administration Schedule; Female; Humans; Hypothalamo-Hypophyseal System; Infant; Male; Pituitary-Adrenal System; Treatment Outcome; United States
PubMed: 18638631
DOI: 10.1016/j.jaad.2008.04.019 -
Skinmed 2007
Topics: Adolescent; Adrenal Insufficiency; Child; Child, Preschool; Dermatitis, Atopic; Desonide; Gels; Glucocorticoids; Humans; Infant
PubMed: 17786103
DOI: 10.1111/j.1540-9740.2007.07319.x -
Skinmed 2007
Topics: Anti-Inflammatory Agents; Desonide; Dosage Forms; Humans; Skin Diseases
PubMed: 17215617
DOI: 10.1111/j.1540-9740.2007.06180.x -
Journal of Photochemistry and... Oct 2019This study aimed to develop Eudragit® RL 100 nanocapsules loaded with desonide (DES) using açai oil (AO) or medium chain triglycerides (MCT) as oil core....
This study aimed to develop Eudragit® RL 100 nanocapsules loaded with desonide (DES) using açai oil (AO) or medium chain triglycerides (MCT) as oil core. Pre-formulation study showed that AO and MCT are suitable for nanocapsules preparation. The nanocapsules prepared with AO and MCT presented mean particle size around 165 and 131 nm, respectively; polydispersity index values <0.20, positive zeta potential values, drug content close to the theoretical value (0.25 mg mL), and DES encapsulation efficiency around 81%, regardless of the oil core (AO or MCT). Considering the photoinstability reported to DES, photodegradation studies were performed. The UV-A (365 nm) and UV-C (254 nm) photodegradation studies revealed less DES degradation when associated to the nanocapsules containing AO in comparison to those with MCT. The in vitro release study showed a biphasic release profile for both nanocapsule suspensions: an initial burst effect followed by a prolonged DES release. In addition, the formulations were considered non-phototoxic at 0.5 mg mL when tested on 3 T3 murine fibroblasts and HaCaT human keratinocytes using the MTT and NRU viability assays. The irritant potential of the prepared nanocapsules and DES in free form were evaluated by HET-CAM method. All formulations were classified as slightly irritant, including the non-associate DES. In conclusion, the nanocapsule formulations developed in this study may be promising for therapeutic applications.
Topics: Animals; Anti-Inflammatory Agents; Cell Line; Cell Survival; Desonide; Drug Compounding; Drug Liberation; Drug Stability; Euterpe; Humans; Light; Mice; Nanocapsules; Particle Size; Photolysis; Plant Oils; Polymethacrylic Acids; Suspensions; Triglycerides
PubMed: 31522112
DOI: 10.1016/j.jphotobiol.2019.111606 -
Cornea Jul 2002To study the safety and efficacy of the topical corticosteroid, desonide 0.25% ophthalmic solution, for inhibition of the clinical allergic reaction induced by... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
PURPOSE
To study the safety and efficacy of the topical corticosteroid, desonide 0.25% ophthalmic solution, for inhibition of the clinical allergic reaction induced by conjunctival provocation (CPT) and for the treatment of seasonal allergic conjunctivitis (SAC).
METHODS
For the CPT study, 12 allergic but inactive patients were exposed in both eyes to increasing doses of a specific allergen until a positive bilateral, symmetrical early- and late-phase reaction was obtained. After 2 weeks the last positive dose was readministrated and their positive response confirmed. After an additional 2 weeks, CPT was performed 30 minutes after topical administration of desonide in one eye and placebo in the contralateral eye (Group A) or after topical desonide or placebo four times a day for 2 days (Group B). Clinical signs and symptoms were recorded after 15, 30, and 60 minutes, and after 6 hours. Regarding the seasonal study, 96 patients with active SAC were treated bilaterally with either desonide or fluorometholone for 3 weeks, and allergic signs and symptoms evaluated at regular intervals. The safety of the drugs was assessed by identification of any side effects or adverse events of any kind.
RESULTS
For the CPT study: individual itching and redness, and the sum score for signs and symptoms were all statistically (p < 0.05) and clinically (greater than 1 change between treated eyes) significantly lower in desonide versus placebo eyes. Both early- and late-phase reactions were reduced by desonide pretreatment. Seasonal study: desonide and fluorometholone were both highly effective in reducing itching, tearing, and conjunctival hyperemia over time (p < 0.0001). Both drugs appeared safe, with no statistically significant changes in IOP observed with either treatment.
CONCLUSIONS
Desonide has a significant therapeutic effect on both the induced conjunctival early- and late-allergic reaction and in active SAC. It was also safe, with no side effects such as increases in intraocular pressure observed by physician or patient.
Topics: Administration, Topical; Adolescent; Adult; Allergens; Anti-Inflammatory Agents; Conjunctivitis, Allergic; Desonide; Diagnostic Techniques, Ophthalmological; Double-Blind Method; Drug Evaluation; Female; Fluorometholone; Glucocorticoids; Humans; Male; Ophthalmic Solutions; Radioallergosorbent Test; Safety
PubMed: 12072722
DOI: 10.1097/00003226-200207000-00008