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The Journal of Dermatological Treatment Jun 2018The safety and potential side effects of desoximetasone 0.25% and 0.05% sprays have not previously been studied. The primary objective of this study was to determine the... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
The safety and potential side effects of desoximetasone 0.25% and 0.05% sprays have not previously been studied. The primary objective of this study was to determine the irritation potential of desoximetasone 0.25%, 0.05% and vehicle sprays in response to irradiation.
MATERIALS AND METHODS
Thirty-four subjects were enrolled in the study, each with three study treatments (desoximetasone 0.25%, 0.05% topical sprays and vehicle) were applied to two sites each on the back of every subject, with half of the sites irradiated with filtered UV light. Dermal reactions at the test sites were evaluated using a visual scale with corresponding numerical scores that rated the degree of erythema and oedema.
RESULTS
Desoximetasone 0.25%, 0.05%, and vehicle caused no detectable signs of phototoxicity when examined on days 3 and 4. Mean scores of desoximetasone 0.25%, 0.05% and vehicle to non-irradiated treatment areas showed no signs of irritation.
CONCLUSIONS
Our results suggest that regular application of desoximetasone 0.25% and 0.05% topical sprays do not induce photosensitization or photoirritation. The safety of this topical spray may help with clinical management of patients using topical corticosteroids while also receiving therapeutic UV light exposure. Thus, patients can use desoximetasone sprays without concerns of side effects due to therapeutic light or sun exposure.
Topics: Administration, Topical; Adult; Dermatologic Agents; Desoximetasone; Double-Blind Method; Erythema; Female; Humans; Male; Middle Aged; Skin; Ultraviolet Rays; Young Adult
PubMed: 29098908
DOI: 10.1080/09546634.2017.1395797 -
The Journal of Dermatological Treatment May 2018Desoximetasone 0.25% topical spray is a novel formulation that has not been tested or approved for safety and efficacy. The primary objective was to determine the... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Desoximetasone 0.25% topical spray is a novel formulation that has not been tested or approved for safety and efficacy. The primary objective was to determine the potential of desoximetasone 0.25 and 0.05% topical sprays, as well as a vehicle to induce photoallergic skin reaction after repeated topical application and irradiation to the skin using a controlled photopatch testing procedure.
MATERIALS AND METHODS
53 subjects completed the study, each with six application sites (two of each treatment), three of which were irradiated and three non-irradiated, for an induction period of three weeks and then challenge period at week 6.
RESULTS
Desoximetasone 0.25 and 0.05%, as well as vehicle showed no evidence of potential to induce photosensitization. There was statistically significantly greater irritation at the vehicle irradiated site in comparison to the irradiated treatment area of desoximetasone 0.25% (p = .005) and the irradiated treatment area of desoximetasone 0.05% (p = .008).
CONCLUSION
Our results suggest that regular treatment with desoximetasone 0.25 and 0.05% spray, followed by UV light exposure does not induce photosensitization or photo-irritation. These findings increase confidence for the use of this topical spray in eczema or psoriasis patients who may also be receiving UV light therapy and may contribute to the clinical management of these patients.
Topics: Administration, Topical; Adolescent; Adult; Aged; Desoximetasone; Drug Administration Schedule; Drug Compounding; Female; Gastrointestinal Diseases; Humans; Infections; Male; Middle Aged; Skin; Treatment Outcome; Ultraviolet Rays; Young Adult
PubMed: 29098900
DOI: 10.1080/09546634.2017.1395803 -
Journal of Cutaneous Medicine and... 2019Topical corticosteroids (TS) are a treatment for atopic dermatitis (AD) and psoriasis (Ps). We assessed whether use of a TS under conditions designed to enhance... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE:
Topical corticosteroids (TS) are a treatment for atopic dermatitis (AD) and psoriasis (Ps). We assessed whether use of a TS under conditions designed to enhance adherence would be effective in patients who "failed" TS in the outpatient setting.
METHODS:
Individuals with treatment-resistant Ps or AD were recruited (AD, n = 12; Ps, n = 12). Six participants were randomized to each of 2 groups of desoximetasone 0.25% spray alone (n = 6) or desoximetasone spray plus twice-daily phone call reminders to use the medication. Disease severity was assessed.
RESULTS:
In treatment-resistant Ps patients, desoximetasone spray, with reminders, resulted in statistically significant improvement in all outcome measures. In treatment-resistant AD patients, there was statistically significant improvement in some assessments. Despite the very small sample size and short evaluation time, statistically significant changes were detected in this cohort. This is evidence of the large effect size of TS for Ps and AD when the treatment is used.
CONCLUSIONS:
Patients with "treatment-resistant" Ps and AD generally responded well to the use of desoximetasone spray in the trial setting. This may be due to better adherence in the study environment or patients' preference for the spray vehicle. Patient reminders contributed to improved clinical outcomes in Ps and AD patients with "treatment-resistant" disease.
Topics: Administration, Cutaneous; Adult; Aged; Anti-Inflammatory Agents; Dermatitis, Atopic; Desoximetasone; Drug Resistance; Female; Humans; Male; Medication Adherence; Middle Aged; Psoriasis; Reminder Systems; Severity of Illness Index; Telephone; Young Adult
PubMed: 30556414
DOI: 10.1177/1203475418818082 -
The Journal of Dermatological Treatment Feb 2018Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative formulations have gained popularity due to their ease of application, improved adherence and efficacy.
OBJECTIVE
To evaluate the efficacy of topical desoximetasone 0.25% spray formulation in extensive psoriasis.
METHODS
This multicenter, double-blinded, randomized trial compared twice daily topical 0.25% desoximetasone spray to placebo in subjects ≥18 with moderate to severe plaque psoriasis. Primary outcome of the study was the proportion of subjects in each group that achieved clinical success (Physician Global Assessment [PGA] of 0 or 1) and/or treatment success at (target lesion score of 0 or 1) day 28.
RESULTS
One-hundred-and-twenty subjects were enrolled. At baseline, 75.0% and 73.3% of the treatment and placebo group had at least moderate PGA, respectively. Clinical success in the intended-to treat and placebo group was 30% and 5% (p = .0003), respectively; treatment success was 39% and 7% (p < .0001), respectively.
LIMITATIONS
The lack of standardized outcomes for topical psoriasis treatments limits the ability to compare the results to other treatments.
CONCLUSIONS
Topical desoximetasone spray provides rapid control of moderate to severe psoriasis lesions and may be considered for patients awaiting approval of biologicals.
TRIAL REGISTRATION
Clinical Trial was registered at clinicaltrial.gov: NCT01206387.
Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Dermatologic Agents; Desoximetasone; Double-Blind Method; Drug Administration Schedule; Drug Compounding; Female; Humans; Male; Middle Aged; Placebo Effect; Psoriasis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 28504031
DOI: 10.1080/09546634.2017.1331027 -
Journal of Drugs in Dermatology : JDD Dec 2013Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray 0.25%, a super-potent topical... (Randomized Controlled Trial)
Randomized Controlled Trial
Two Phase 3, double-blind, randomized, vehicle-controlled parallel studies evaluated the efficacy and safety of desoximetasone spray 0.25%, a super-potent topical corticosteroid, twice daily vs vehicle spray twice daily for 28 days in adult patients with moderate to severe plaque psoriasis. At baseline and throughout the study, the severity of disease for the psoriatic lesions was assessed using the Physician Global Assessment (PGA) score and a target lesion was assessed using the Total Lesion Severity Score (TLSS). A designated psoriatic plaque lesion was selected as the target lesion upon enrollment and evaluated throughout the study to determine the TLSS. To qualify for study entry, the subject needed to exhibit a PGA score of 3 (moderate) or 4 (severe) for overall disease severity, and a target lesion with an area of at least 5 cm(2) that achieved a combined score TLSS of >=7, with a plaque elevation score of >=3 (at least moderate). The mean % BSA affected by psoriasis ranged from 13%-17% at baseline. In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily. Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Dermatologic Agents; Desoximetasone; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Psoriasis; Severity of Illness Index; Treatment Outcome; Young Adult
PubMed: 24301242
DOI: No ID Found -
Journal of Drugs in Dermatology : JDD Oct 2017Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might... (Comparative Study)
Comparative Study Randomized Controlled Trial
A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation.
BACKGROUND
Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of desoximetasone spray is not fully characterized.
OBJECTIVE
To evaluate the relative vasoconstrictive potency of desoximetasone 0.25% topical spray formulation.
METHODS
This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device.
RESULTS
Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported.
LIMITATIONS
The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to desoximetasone spray.
CONCLUSIONS
Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice.
J Drugs Dermatol. 2017;16(10):972-975.
.Topics: Administration, Cutaneous; Adolescent; Adult; Anti-Inflammatory Agents; Clobetasol; Desoximetasone; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Middle Aged; Vasoconstriction; Vasoconstrictor Agents; Young Adult
PubMed: 29036250
DOI: No ID Found -
Journal of Drugs in Dermatology : JDD Dec 2003The physical and chemical compatibility of desoximetasone ointment 0.25% and tacrolimus ointment 0.1%, both widely used to treat atopic dermatitis, were determined. A...
The physical and chemical compatibility of desoximetasone ointment 0.25% and tacrolimus ointment 0.1%, both widely used to treat atopic dermatitis, were determined. A 1:1 (w/w) mixture of desoximetasone ointment 0.25% (Topicort, Taro Pharmaceuticals USA, Inc.) and tacrolimus ointment 0.1% (Protopic, Fujisawa Healthcare, Inc.) were prepared and stored under three different temperature/relative humidity conditions: 25 degrees C/60% RH; 30 degrees C/60% RH; and 40 degrees C/75% RH. Unmixed ointments stored under the same temperature and humidity conditions as the mixture served as controls. Samples were evaluated at days 1, 2, 7, 14, and 28 for color, degree of physical separation, and chemical stability via reverse-phase high performance liquid chromatography. Ranges of relative recovery for each active ingredient for all storage conditions ((% Mixture/% Control) x 100) were 89.6-109.3% for tacrolimus and 99.0-103.4% for desoximetasone. No significant difference in physical appearance or chromatographic profile between the mixture and controls was observed. Therefore, we conclude that desoximetasone ointment 0.25% (Topicort) and tacrolimus ointment 0.1% (Protopic) are physically and chemically compatible up to four weeks when mixed in a ratio of 1:1 (w/w).
Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Chemistry, Pharmaceutical; Dermatitis, Atopic; Desoximetasone; Drug Stability; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Ointments; Tacrolimus
PubMed: 14711143
DOI: No ID Found -
The Journal of Clinical and Aesthetic... May 2018The goal of this study was to evaluate efficacy and safety of desoximetasone spray 0.25%, a topical corticosteroid, in the management of scalp and body psoriasis. This...
The goal of this study was to evaluate efficacy and safety of desoximetasone spray 0.25%, a topical corticosteroid, in the management of scalp and body psoriasis. This was an open-label, observational study. Twenty adults aged 18 years or older with chronic scalp psoriasis present on at least 30 percent of the scalp surface area and an Investigator Global Assessment (IGA) scale score of scalp disease of at least 2 on a scale of 0 to 4 were included in the study. Study spray was applied twice daily for four weeks, followed by 12 weeks of twice-daily application for two consecutive days weekly. At Week 4, the mean Physician Global Assessment (PGA) scale score had decreased 54.8 percent, from moderate disease to almost clear. Body surface area (BSA) had decreased by 51.2 percent, BSA × PGA had decreased by 63 percent, and scalp IGA had decreased by 64.5 percent from moderate to almost clear. Additionally, mean Psoriasis Scalp Severity Index (PSSI) score was 27.3±10.0 at baseline and decreased 82.4 percent to 4.8±5.2 and scalp surface area (SSA) was reduced by 70.7 percent at Week 4. The initial Scalp Index score was a mean of 65.7±15.0 at baseline and was reduced by 44.3 percent and 40.8 percent at Weeks 4 and 16, respectively. The initial response was maintained after a change to twice-weekly, twice-daily dosing, with a 48.4-percent decrease in PGA, a 17.1-percent decrease in BSA, a 31.5-percent decrease in BSA × PGA, a 51.6-percent decrease in scalp IGA, a 63.4 percent decrease in PSSI, and a 42.3-percent decrease in SSA seen at Week 16. Minimal adverse events were experienced by seven subjects. Desoximetasone spray 0.25% produced rapid improvements in PGA, BSA, BSA×PGA, scalp IGA, PSSI, SSA.
PubMed: 29785235
DOI: No ID Found -
The Medical Letter on Drugs and... Jun 2020
Topics: Administration, Cutaneous; Administration, Oral; Animals; Dermatitis, Atopic; Dermatologic Agents; Humans; Injections
PubMed: 32555122
DOI: No ID Found -
Cutis Mar 1978A new potent topical corticosteroid, desoximetasone, was clinically evaluated in several hundred patients with steroid-responsive dermatoses. Both short-term and... (Clinical Trial)
Clinical Trial Comparative Study
A new potent topical corticosteroid, desoximetasone, was clinically evaluated in several hundred patients with steroid-responsive dermatoses. Both short-term and long-term comparative studies showed desoximetasone emollient cream (0.25 percent) to be highly effective. Studies comparing betamethasone valerate cream C0. p1 percent) with desoximetasone emollient cream (0.25 percent) showed the new topical steroid to be clinically superior in the relief of moderate and severe inflammatory manifestations of psoriasis and atopic dermatitis. In addition, desoximetasone was found to be safe, well tolerated, and accepted by the patients.
Topics: Administration, Topical; Adolescent; Adult; Aged; Betamethasone Valerate; Child; Clinical Trials as Topic; Dermatitis, Atopic; Dexamethasone; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis
PubMed: 344003
DOI: No ID Found