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Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus (AUR0613)

Primary Purpose

Pruritus, Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aurstat Anti-Itch Hydrogel (Aurstat)
Sponsored by
The Center for Clinical and Cosmetic Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Pruritus, Atopic Dermatitis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this study.

  1. Subjects must be diagnosed by the investigator as meeting the criteria for mild to moderate atopic dermatitis, as defined by the Hanifin criteria.
  2. Subjects must score a minimum of 2 on the itch severity scale.
  3. Subjects may not apply other topical products (including moisturizers) to the affected lesions, other than study treatments, for a minimum of 24 hours prior to study initiation and for the duration of the study.
  4. No other oral or topical treatments for atopic dermatitis are allowed during the study.
  5. Subjects on asthma or allergy medications must continue taking these prescription or OTC products without change during the study.
  6. Anti-inflammatory oral medications or oral antihistamines not used at cannot be added during the study or taken on an intermittent basis.
  7. Subjects must be 12-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation, except mild to moderate atopic dermatitis.
  8. Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide), and abstinence.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study.

  1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's response to the study formulation.
  2. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product.
  3. Concurrent therapy with any medication either topical or oral that might interfere with the investigator and/or subject assessments of atopic dermatitis or study product irritancy, based on the opinion of the investigator.
  4. Subjects who have used a topical corticosteroid within 2 weeks of study enrollment.
  5. Subjects who are on oral corticosteroids within 4 weeks of study enrollment, inhaled corticosteroids are allowed if used at baseline and used on a routine basis. Intermittent inhaled corticosteroids are prohibited.
  6. Subjects who use an indoor tanning booth.
  7. Subjects who are pregnant, breast feeding or planning a pregnancy.
  8. Subjects with clinically significant unstable medical disorders.

Sites / Locations

  • Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Untreated Control Group

Treatment Group (Aurstat)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

Full Information

First Posted
July 19, 2013
Last Updated
October 20, 2022
Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
Onset Dermatologics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01905631
Brief Title
Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Acronym
AUR0613
Official Title
A 3-Day Investigator Blinded, Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
Onset Dermatologics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Atopic Dermatitis
Keywords
Pruritus, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Untreated Control Group
Arm Type
No Intervention
Arm Description
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 Title
Treatment Group (Aurstat)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aurstat Anti-Itch Hydrogel (Aurstat)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of Itching in AD
Description
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)).
Time Frame
3-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet all of the following criteria are eligible for this study. Subjects must be diagnosed by the investigator as meeting the criteria for mild to moderate atopic dermatitis, as defined by the Hanifin criteria. Subjects must score a minimum of 2 on the itch severity scale. Subjects may not apply other topical products (including moisturizers) to the affected lesions, other than study treatments, for a minimum of 24 hours prior to study initiation and for the duration of the study. No other oral or topical treatments for atopic dermatitis are allowed during the study. Subjects on asthma or allergy medications must continue taking these prescription or OTC products without change during the study. Anti-inflammatory oral medications or oral antihistamines not used at cannot be added during the study or taken on an intermittent basis. Subjects must be 12-75 years of age with no known medical conditions that, in the investigator's opinion, may interfere with study participation, except mild to moderate atopic dermatitis. Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide), and abstinence. Exclusion Criteria: Patients who meet any of the following criteria are not eligible for this study. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's response to the study formulation. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study product. Concurrent therapy with any medication either topical or oral that might interfere with the investigator and/or subject assessments of atopic dermatitis or study product irritancy, based on the opinion of the investigator. Subjects who have used a topical corticosteroid within 2 weeks of study enrollment. Subjects who are on oral corticosteroids within 4 weeks of study enrollment, inhaled corticosteroids are allowed if used at baseline and used on a routine basis. Intermittent inhaled corticosteroids are prohibited. Subjects who use an indoor tanning booth. Subjects who are pregnant, breast feeding or planning a pregnancy. Subjects with clinically significant unstable medical disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Berman, MD, PhD
Organizational Affiliation
Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark S. Nestor, MD, PhD
Organizational Affiliation
Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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