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.
RCT Entities:
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.
Authors: Jennifer Krejci-Manwaring; Mark G Tusa; Christie Carroll; Fabian Camacho; Mandeep Kaur; David Carr; Alan B Fleischer; Rajesh Balkrishnan; Steven R Feldman Journal: J Am Acad Dermatol Date: 2006-11-13 Impact factor: 11.527
Authors: Adelaide A Hebert; Fran E Cook-Bolden; Sarmistha Basu; Barry Calvarese; Ronald J Trancik Journal: J Drugs Dermatol Date: 2007-02 Impact factor: 2.114
Authors: Brad A Yentzer; Fabian T Camacho; Trudye Young; Julie M Fountain; Adele R Clark; Steven R Feldman Journal: J Drugs Dermatol Date: 2010-04 Impact factor: 2.114
Authors: Donald Y M Leung; Mark Boguniewicz; Michael D Howell; Ichiro Nomura; Qutayba A Hamid Journal: J Clin Invest Date: 2004-03 Impact factor: 14.808