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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right side | Experimental | Patients were randomized to apply Locoid Lipocream on the right side of the target lesion followed by Hylatopic Plus lotion on the left side of the target lesion with the reverse order on the other side. |
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| Left first | Active Comparator | Patients were randomized to apply Locoid Lipocream on the left side of the target lesion followed by Hylatopic Plus lotion on the right side of the target lesion with the reverse order on the other side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locoid Lipocream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Treatment Success at 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. | baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline SPGA scale at 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. | baseline and Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Zeichner, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Hylatopic Plus | Drug | 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. |
|
|
| Change from Baseline Pruritus at Day 29 | Change from baseline pruritus at day 29 | baseline and Day 29 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |