Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus

NCT01905631 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-10-24

Study results available
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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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Onset Dermatologics, Inc.

    collaborator UNKNOWN
  • The Center for Clinical and Cosmetic Research

    lead OTHER

Principal Investigators

  • Brian Berman, MD, PhD · Center for Clinical and Cosmetic Research

  • Mark S. Nestor, MD, PhD · Center for Clinical and Cosmetic Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01905631 on ClinicalTrials.gov