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Clinical, Cosmetic and Investigational... 2013Axillary hyperpigmentation is a frequent cause of cosmetic consultations in dark-skinned women from tropical areas, including Latin America. Currently, there is no...
BACKGROUND
Axillary hyperpigmentation is a frequent cause of cosmetic consultations in dark-skinned women from tropical areas, including Latin America. Currently, there is no widely accepted treatment for the disorder, but it is usually treated with bleaching agents because it is considered a variant of inflammatory hyperpigmentation. The purpose of this study was to assess the efficacy of niacinamide 4% and desonide 0.05% emulsions compared with placebo in the treatment of axillary hyperpigmentation.
METHODS
Twenty-four women aged 19-27 years with hyperpigmented axillae (phototype III-V) were randomly assigned to receive the study treatments in the axillary region. Improvement was assessed at baseline, then clinically and by colorimetry 9 weeks later. Quantitative evaluation including melanin, inflammatory infiltrates, NKI/Beteb, CD1a, CD68, and collagen type IV content was performed by histochemistry and immunohistochemistry, assisted by computerized morphometric analysis.
RESULTS
Both niacinamide and desonide induced significant colorimetric improvement compared with placebo; however, desonide showed a better depigmenting effect than niacinamide. A good to excellent response was achieved in 24% of cases for niacinamide, 30% for desonide, and 6% for placebo. We observed a marked disruption of the basal membrane in axillary hyperpigmentation and an inflammatory infiltrate that improved after treatment. Decreased pigmentation in the desonide-treated axillae was associated with recovery of disruption at the basal membrane.
CONCLUSION
Niacinamide and desonide showed depigmenting properties in women with axillary hyperpigmentation. These findings may be explained by their antimelanogenic and anti-inflammatory properties, respectively.
PubMed: 23355788
DOI: 10.2147/CCID.S39246 -
The Journal of Clinical and Aesthetic... Nov 2011Desonide hydrogel 0.05%, an effective treatment for mild-to-moderate atopic dermatitis, is United States Food and Drug Administration approved as a treatment for...
OBJECTIVE
Desonide hydrogel 0.05%, an effective treatment for mild-to-moderate atopic dermatitis, is United States Food and Drug Administration approved as a treatment for patients as young as three months of age. Previous studies have also demonstrated that this hydrogel formulation of desonide 0.05% improved moisturization and reduced transepidermal water loss. Increased skin hydration has been correlated with improved and sustained integrity of the epidermal barrier in patients with atopic dermatitis. The objective of this clinical noninferiority study was to compare the efficacy of desonide hydrogel 0.05% with desonide ointment 0.05%, the clinical standard for the treatment of mild-to-moderate atopic dermatitis.
DESIGN AND SETTING
Randomized, investigator-blinded, parallel-group, noninferiority study in an outpatient setting.
PARTICIPANTS
Individuals 12 years of age and older with atopic dermatitis.
MEASUREMENTS
Outcome measures included disease severity, body surface area involvement, subjective assessments of symptoms, corneometry, transepidermal water loss, and the patient's preference for vehicle attributes. Patients were assessed at Baseline, Week 2, and Week 4.
RESULTS
Desonide hydrogel 0.05% was shown, through visual grading assessments and noninvasive instrumentation measurements, to be as effective as generic desonide ointment 0.05% in reducing the signs and symptoms of mild-to-moderate atopic dermatitis in patients aged 12 to 65 years during a four-week period. In addition, patients rated desonide hydrogel significantly better than desonide ointment for absorbability and (lack of) greasiness.
CONCLUSION
Desonide hydrogel, which uses a hydrogel vehicle, was preferred by patients and shown to restore the skin barrier, thus offering an efficacious alternative to desonide ointment.
PubMed: 22125657
DOI: No ID Found -
Pediatric Dermatology 2007Desonide, a low potency corticosteroid, has been used widely as a topical treatment for inflammatory dermatoses for over 30 years. A recent formulation advance has... (Clinical Trial)
Clinical Trial
Desonide, a low potency corticosteroid, has been used widely as a topical treatment for inflammatory dermatoses for over 30 years. A recent formulation advance has enabled the development of desonide 0.05% into a novel moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. This multicenter, open-label study evaluated the hypothalamic-pituitary-adrenal axis suppression potential, tolerability, and efficacy of this new Class VI topical steroid formulation in pediatric subjects with moderate-to-severe atopic dermatitis (mean body surface area = 51%). Forty children, aged 6 months to 6 years were enrolled and treated twice daily for 4 weeks. Desonide hydrogel 0.05% was well tolerated and no treatment-related adverse events were reported. No suppression of adrenal function was observed in subjects who completed the study without protocol violations related to cosyntropin administration or cortisol testing (n=34). Of the subjects who completed the study with complications in cortisol testing (n=3), there was one subject (1/37=3%) who had a low poststimulation cortisol level at week 4. Efficacy was demonstrated by marked improvement in overall disease state and in the signs and symptoms of atopic dermatitis. This study validates the systemic safety of a novel desonide hydrogel formulation in young pediatric patients and confirms the longstanding tolerability and efficacy profile of desonide.
Topics: Anti-Inflammatory Agents; Child; Child, Preschool; Cosyntropin; Dermatitis, Atopic; Desonide; Female; Hormones; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Infant; Male; Pituitary-Adrenal System; Severity of Illness Index; Treatment Outcome
PubMed: 17542883
DOI: 10.1111/j.1525-1470.2007.00405.x -
Journal of Drugs in Dermatology : JDD Feb 2007Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most prevalent in the younger pediatric population and is... (Randomized Controlled Trial)
Randomized Controlled Trial
Low to mid potency corticosteroids remain a cornerstone of therapy for atopic dermatitis (AD). Since AD is most prevalent in the younger pediatric population and is chronic in nature, safety is of particular concern especially for children under 2 years of age. A novel desonide (0.05%) formulation was developed in a nonirritating and moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. The safety and efficacy of this new class VI low potency topical steroid was substantiated in 2 phase III clinical trials in mild to moderate AD subjects aged 3 months to 18 years (mean age 6.7 years and 30% under 3 years). A total of 425 subjects were treated with desonide hydrogel and 157 subjects with the hydrogel vehicle. Desonide hydrogel 0.05% was extremely well-tolerated and provided statistically significant improvements in all primary (P < .001) and secondary (P < .006) efficacy endpoints in both studies. This novel desonide formulation represents an advancement in the treatment of AD.
Topics: Adolescent; Anti-Inflammatory Agents; Child; Child, Preschool; Dermatitis, Atopic; Desonide; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Hydrogels; Infant; Male; Steroids; Treatment Outcome
PubMed: 17373176
DOI: No ID Found -
Journal of Pharmaceutical and... Nov 2018A novel HPLC method for the determination of the impurities in desonide cream was established and validated for the further improvement of the official monograph in USP....
A novel HPLC method for the determination of the impurities in desonide cream was established and validated for the further improvement of the official monograph in USP. Desonide was well resolved from the photodegradation impurity, which overlapped with desonide in USP method. The method was validated in accordance to the regulatory guidelines recommended by the International Conference on Harmonisation and this validation included specificity, limit of detection, limit of quantification, linearity and accuracy. Four degradation impurities in desonide cream were characterized by a trap-free two-dimensional liquid chromatography coupled to high resolution ion trap/time-of-flight mass spectrometry (2D LC-IT-TOF MS) in positive mode of electrospray ionization. Through the multiple heart-cutting 2D LC approach and online demineralization technique, the problem of incompatibility between non-volatile salt mobile phase and mass spectrometry was solved completely, and the TIC chromatogram of LC-MS could be in conformity with the LC chromatogram of the official analytical method in the peak sequence of impurities. In the first dimension, the column was Phenomenex Kinetex C8 (4.6 mm × 150 mm, 2.6 μm) with a non-volatile salt mobile phase. In the second dimension, the column was Shimadzu Shim-pack GISS C18 (50 mm × 2.1 mm, 1.9 μm) with a volatile salt mobile phase. The structures of four degradation impurities in desonide cream were deduced based on the HPLC-MS data. The established method in this study was simple and reliable for routine quality control of desonide cream.
Topics: Chromatography, High Pressure Liquid; Chromatography, Liquid; Desonide; Drug Contamination; Skin Cream; Spectrometry, Mass, Electrospray Ionization
PubMed: 30205304
DOI: 10.1016/j.jpba.2018.08.055 -
Cutis Jul 2011The stratum corneum typically is compromised in patients with atopic dermatitis (AD). Beneficial AD treatments should provide moisture to the skin as well as restore... (Clinical Trial)
Clinical Trial
The stratum corneum typically is compromised in patients with atopic dermatitis (AD). Beneficial AD treatments should provide moisture to the skin as well as restore impaired barrier function. Traditional treatments involve ointments or creams. A clinical study was conducted to determine if desonide in a hydrogel vehicle (HGV) could improve the moisture content and barrier function of the stratum corneum in adults with mild to moderate AD. Participants applied desonide hydrogel 0.05% twice daily for 4 weeks to areas of both lesional and nonlesional skin. Corneometry and transepidermal water loss (TEWL) were measured at baseline and weeks 1, 2, and 4. Statistically significant improvements in corneometry and TEWL measurements on lesional skin were observed at all study visits compared with baseline (all P < or = .002 and P < or = .04, respectively).
Topics: Administration, Cutaneous; Adult; Anti-Inflammatory Agents; Dermatitis, Atopic; Desonide; Female; Humans; Hydrogels; Male; Middle Aged; Severity of Illness Index; Skin; Treatment Outcome; Water Loss, Insensible; Young Adult
PubMed: 21916151
DOI: No ID Found -
Journal of Drugs in Dermatology : JDD Jun 2014Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most... (Clinical Trial)
Clinical Trial
Itch is a common and troubling symptom of atopic dermatitis. It is not mediated by histamine, and standard anti-itch therapies, therefore, have limited benefit for most AD patients. Instead, anti-inflammatory agents are used to reduce inflammation and therefore improve associated itch. Studies confirm that long-term use of corticosteroids can lead to a reduction in pruritus. A pilot study was designed to assess the effects of one week of twice-daily application of desonide hydrogel 0.05% for the treatment of atopic dermatitis. Active treatment was associated with significant improvements in IGA scores at day 3 and day 7 (mean score 0.55, 75.83% improvement from Baseline; P <.0001) and pruritus VAS scores at day 3 and day 7 (mean 6.35-point, 86.61% reduction in VAS scores; P <.0001). Treatment with the convenient, hydrating hydrogel formulation is effective and associated with an improvement in subjects' quality of life.
Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Child; Dermatitis, Atopic; Desonide; Female; Humans; Hydrogel, Polyethylene Glycol Dimethacrylate; Male; Middle Aged; Pilot Projects; Pruritus; Quality of Life; Treatment Outcome; Young Adult
PubMed: 24918564
DOI: No ID Found -
Chemical & Pharmaceutical Bulletin Jun 2006The photochemistry of anti-inflammatory drug desonide (De, 1) was studied in aerobic as well as in anaerobic condition with different irradiation wavelengths (254, 310...
The photochemistry of anti-inflammatory drug desonide (De, 1) was studied in aerobic as well as in anaerobic condition with different irradiation wavelengths (254, 310 nm) in acetonitrile and 2-propanol. All photoproducts obtained were isolated and characterized on the basis of IR, (1)H-, (13)C-NMR spectroscopy and elemental analysis study. The products were: 11beta,21-dihydroxy-16alpha,17alpha-(1-methylethylidenedioxy)-1,5-cyclopregn-3-ene-2,20-dione 2 (254 nm), 11beta-hydroxy-16alpha,17alpha-(1-methylethylidenedioxy)androsta-1,4-diene-3-one 3 (310 nm/2-propanol), 17beta-hydroperoxy-11beta-hydroxy-16alpha,17alpha-(1-methylethylidenedioxy)androsta-1,4-diene-3-one 4 (310 nm/O(2)/2-propanol). Cyclohexadienone moiety in ring A and keto group at C(17) were found to be deeply modified by UV light therefore, loss of biological activity both during storage and in vivo can not be ruled out.
Topics: 2-Propanol; Acetonitriles; Animals; Anti-Inflammatory Agents, Non-Steroidal; Desonide; Drug Stability; Molecular Structure; Oxygen; Photochemistry
PubMed: 16755054
DOI: 10.1248/cpb.54.836 -
Pakistan Journal of Pharmaceutical... May 2019To observe and analyze the clinical efficacy of mucopolysaccharide polysulfate (MPS) ointment combined with desonide ointment in treatment of infantile eczema. A total... (Randomized Controlled Trial)
Randomized Controlled Trial
To observe and analyze the clinical efficacy of mucopolysaccharide polysulfate (MPS) ointment combined with desonide ointment in treatment of infantile eczema. A total of 180 infants who had been treated for eczema at our hospital were enrolled. The patients were divided into control group accepting desonide ointment only and research group accepting mucopolysaccharide polysulfate ointment and desonide ointment. The therapeutic efficacies of two groups were compared. Results: By comparing the total therapeutic efficacy, results showed that the total efficacy of the research group was 96.67%, while that value of the control group was 82.22%, making the total efficacy of the research group significantly higher (p<0.05). And the improvement of the Eczema Area and Severity Index (EASI) score in the research group after drug administration was significantly better than that of the control group (p<0.05). Moreover, there was a greater decrease in the recurrence rate of the research group than that of the control group (p<0.05). Combined application of mucopolysaccharide polysulfate ointment and desonide ointment can achieve better therapeutic effect in treatment of infantile eczema.
Topics: Anti-Inflammatory Agents; Child, Preschool; Dermatitis, Atopic; Desonide; Drug Therapy, Combination; Female; Glycosaminoglycans; Humans; Infant; Male; Ointments; Treatment Outcome
PubMed: 31551225
DOI: No ID Found -
Journal of Drugs in Dermatology : JDD Aug 2019BACKGROUND: Topical corticosteroids are efficacious treatment options for multiple dermatoses. However, ointments and cream corticosteroid vehicles can be cumbersome to... (Review)
Review
BACKGROUND: Topical corticosteroids are efficacious treatment options for multiple dermatoses. However, ointments and cream corticosteroid vehicles can be cumbersome to patients and may act as a barrier to adherence. Foam vehicles may be preferred by some patients. OBJECTIVE: To evaluate the efficacy and safety of topical corticosteroid foams. METHODS: A literature review was conducted using the keywords “clobetasol,” “betamethasone,” “propionate,” “valerate,” “topical,” “foam,” “vehicles,” “desonide,” and “clinical trial.” Thirty-seven articles were chosen. RESULTS: For moderate plaque-type psoriasis, 68% of subjects using clobetasol propionate foam achieved a Physician Static Global Assessment score of 0 or 1 at week 2 compared with 21% in the control group (P<0.0001). For betamethasone valerate (BMV) foam, a 12-week regimen for alopecia areata yielded a mean Investigator Global Assessment score of 2.9 compared with placebo (4.6; P<0.001) and achieved ≥75% hair regrowth in 42.86% of subjects. Furthermore, BMV foam cleared or almost cleared 72% of scalp psoriasis subjects compared with BMV lotion (P≤0.005%). For calcipotriol plus betamethasone dipropionate foam, 38.3% of psoriasis subjects achieved treatment success compared with placebo (22.5%; P<0.001). Desonide 0.05% foam was superior to vehicle foam in pediatric atopic dermatitis subjects. CONCLUSION: Topical corticosteroid foams can be used for a variety of corticosteroid-responsive dermatoses. Topical corticosteroid foams are generally easy to apply and may improve patient adherence and, therefore, clinical outcome in patients who prefer a convenient and less messy topical therapy.
Topics: Administration, Cutaneous; Clinical Trials as Topic; Glucocorticoids; Medication Adherence; Patient Preference; Pharmaceutical Vehicles; Skin Diseases; Treatment Outcome
PubMed: 31424707
DOI: No ID Found