PruritusPhase 2AUR0613NCT01905631
Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
A Phase 2 study testing Aurstat Anti-Itch Hydrogel (Aurstat) in people with Pruritus and Atopic Dermatitis, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Pruritus, Atopic Dermatitis
- What is being tested?
- Aurstat Anti-Itch Hydrogel (Aurstat)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Subjects who use an indoor tanning booth.
- Subjects who are pregnant, breast feeding or planning a pregnancy.
- Subjects with clinically significant unstable medical disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
About this study
Official title: A 3-Day Investigator Blinded, Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
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.
Read the 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.
- Conditions
- Pruritus, Atopic Dermatitis
- Being tested
- Aurstat Anti-Itch Hydrogel (Aurstat)
- Keywords
- Pruritus, Atopic Dermatitis
- Medical subject headings
- Pruritus, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aurstat Anti-Itch Hydrogel (Aurstat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 3-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Clinical and Cosmetic Research
- Sponsor type
- University, hospital or other
- Collaborators
- Onset Dermatologics, Inc.
- Responsible party
- Principal investigator, Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research
- Investigators
- Brian Berman, MD, PhD, Principal investigator, Center for Clinical and Cosmetic ResearchMark S. Nestor, MD, PhD, Principal investigator, Center for Clinical and Cosmetic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905631
- Sponsor's protocol ID
- AUR0613
- Acronym
- AUR0613
- Status last verified
- Oct 2022
- First submitted
- 19 Jul 2013
- Last updated
- 24 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Day Investigator Blinded, Randomized Study Evaluating Aurstat Anti-Itch Hydrogel Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
- ClinicalTrials.gov ID
- NCT01905631
- Acronym / sponsor ID
- AUR0613 / AUR0613
- Conditions
- Pruritus, Atopic Dermatitis
- Keywords
- Pruritus, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Center for Clinical and Cosmetic ResearchUniversity, hospital or other
- Collaborators
- Onset Dermatologics, Inc.
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 24 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment Group (Aurstat) |
Primary outcome
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)).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Berman, MD, PhD principal investigator
Center for Clinical and Cosmetic Research
Mark S. Nestor, MD, PhD principal investigator
Center for Clinical and Cosmetic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aurstat Anti-Itch Hydrogel (Aurstat) in people with Pruritus and Atopic Dermatitis, run by The Center for Clinical and Cosmetic Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Itching in AD (time frame: 3-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.