Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02153762
The purpose of this study is to evaluate the safety and tolerability, as well as effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash.Topical skin barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added lipids (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to the the treatment of atopic dermatitis. BRTs are often used along with topical steroids (medicated creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single treatment) on both non-diseased and diseased skin. Since BRTs help to restore components of skin that are absent in skin with AD, it is believed that long-term BRT use may reduce further development of further AD. This is an open-label, single site study.
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Notify Me3 month and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other names: Topical skin barrier repair therapies (BRT)
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other names: Topical skin barrier repair therapies (BRT)
Time frame: baseline and Day 29
Treatment Success defined as Clear or Almost Clear (0 or 1) on the 5 point static physician global assessment of psoriasis (SPGA) scale at day 29, evaluating non-inferiority of one group compared to the other using the lower limit of the confidence interval for the difference in success proportions, as compared to baseline.
Time frame: baseline and Day 29
2 point reduction of SPGA at day 29 as compared to baseline. The sPGA is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.
Time frame: baseline and Day 29
Change from baseline pruritus at day 29
Icahn School of Medicine at Mount Sinai
Other
Assessment of Application Order When Utilizing Locoid Lotion and Hylatopic Plus Cream in the Treatment of Atopic Dermatitis
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