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| Name | Class |
|---|---|
| Onset Dermatologics, Inc. | UNKNOWN |
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To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and photographic evidence based on ordinal scales for tolerability.
This 3-day study will enroll subjects with mild to moderate atopic dermatitis, as defined by the Hanifin criteria.
All subjects will be screened for study enrollment at the baseline visit. Those meeting inclusion/exclusion criteria will be fully consented (or assented) using an IRB-approved ICF. Subjects will then be randomized to either the treatment or control study arm. Those in the treatment arm will be instructed on product application technique and study instructions at baseline. Subjects will apply Aurstat BID, or as needed, to determine frequency of use as a surrogate marker for duration of therapy effect to affected, qualifying atopic dermatitis lesions.
The investigator will assess treatment response using an ordinal scale for tolerability and an IGA scale for disease severity ratings. Subjects will assess treatment response using a VAS to rate pruritus and an ordinal scale to assess tolerability. Photography assessments will be obtained. All adverse events will be captured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated Control Group | No Intervention | Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. | |
| Treatment Group (Aurstat) | Active Comparator | Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aurstat Anti-Itch Hydrogel (Aurstat) | Drug | Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Itching in AD | The ability of Aurstat to reduce itching in those diagnosed with Atopic Dermatitis aged 12-75 years of age. Visual analog score (VAS assessment)- the VAS itch score was defined as the number of millimeters from the left side of a line (154 mm in length) that indicates their level of itching (0 mm (no itching)-154 mm (most itching)). | 3-days |
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Inclusion Criteria:
Patients who meet all of the following criteria are eligible for this study.
Exclusion Criteria:
Patients who meet any of the following criteria are not eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Berman, MD, PhD | Center for Clinical and Cosmetic Research | Principal Investigator |
| Mark S. Nestor, MD, PhD | Center for Clinical and Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Untreated Control Group | Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
| FG001 | Treatment Group (Aurstat) | Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. Aurstat Anti-Itch Hydrogel (Aurstat): Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Untreated Control Group | Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
| BG001 | Treatment Group (Aurstat) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction of Itching in AD | The ability of Aurstat to reduce itching in those diagnosed with Atopic Dermatitis aged 12-75 years of age. Visual analog score (VAS assessment)- the VAS itch score was defined as the number of millimeters from the left side of a line (154 mm in length) that indicates their level of itching (0 mm (no itching)-154 mm (most itching)). | Itch score | Posted | Mean | Standard Deviation | score on a scale | 3-days |
|
3 days
Patients in the placebo group were not at risk for serious adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Untreated Control Group | Subjects will apply nothing for the entire three days of the trial. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial dryness | Skin and subcutaneous tissue disorders | Systematic Assessment | Facial dryness associated with use of IP. Problem resolved with application of gel to face and was noted as a protocol deviation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Nestor | Center for Clinical and Cosmetic Research | 3059336716 | nestormd@admcorp.com |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. Aurstat Anti-Itch Hydrogel (Aurstat): Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. Aurstat Anti-Itch Hydrogel (Aurstat): Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Treatment Group (Aurstat) | Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. Aurstat Anti-Itch Hydrogel (Aurstat): Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial. | 0 | 20 | 1 | 20 |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |