Conditions: Pruritus Atopic Dermatitis
Keywords: Pruritus Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Aurstat Anti-Itch Hydrogel (Aurstat)
Intervention descriptions: intervention 1: 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.

Protocol document: