- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01905631
Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus (AUR0613)
A 3-Day Investigator Blinded, Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Florida
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Aventura, Florida, United States, 33180
- Center for Clinical and Cosmetic Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: 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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ACTIVE_COMPARATOR: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of Itching in AD
Time Frame: 3-days
|
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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark S. Nestor, MD, PhD, Center for Clinical and Cosmetic Research
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Hypersensitivity
- Skin Manifestations
- Skin Diseases, Eczematous
- Dermatitis
- Eczema
- Pruritus
- Dermatitis, Atopic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Diphenhydramine
- Promethazine
Other Study ID Numbers
- AUR0613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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