Atopic DermatitisPhase 2NCT01232985
Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults
A Phase 2 study testing RD047-26 in people with Atopic Dermatitis and Pruritus, run by Oculus Innovative Sciences, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Pruritus
- What is being tested?
- RD047-26
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Female or male, 18 to 65 years of age and in good general health
- Clinical diagnosis of stable mild to moderate atopic dermatitis
- Willing and able to follow study instructions and likely to complete all study requirements
Who cannot join
- Severe or uncontrolled asthma
- Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Official title: An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults
The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.
Read the detailed description
RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.
- Conditions
- Atopic Dermatitis, Pruritus
- Being tested
- RD047-26
- Keywords
- Atopic Dermatitis, Pruritus
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD047-26Device
RD047-26 emollient gel
| Study group | Role | What they receive |
|---|---|---|
| RD047-26 | Experimental | Study Device Receives: Device: RD047-26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment
Investigator Global Assessment of Atopic Dermatitis Severity
Measured: 2 weeks
Secondary outcomes (3)
Investigator Pruritus Assessment
Investigator Pruritus Severity Assessment
Measured: 2 weeks
Subject Itch Assessment
Subject assessment of itch severity
Measured: 2 weeks
Adverse Events
Number of subjects with related adverse events
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oculus Innovative Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zoe Draelos, M.D., Principal investigator, Dermatology Consulting Services, High Point NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232985
- Sponsor's protocol ID
- MIC-AD-001
- Status last verified
- May 2012
- First submitted
- 26 Oct 2010
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Determine the Efficacy and Tolerability of a Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis With Associated Pruritus in Adults
- ClinicalTrials.gov ID
- NCT01232985
- Acronym / sponsor ID
- MIC-AD-001
- Conditions
- Atopic Dermatitis, Pruritus
- Keywords
- Atopic Dermatitis, Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oculus Innovative Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if investigational device, RD047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.
Detailed description
RD047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. The treatment effect will be evaluated by the subject and investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD047-26 | Experimental | Device: RD047-26Study Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Female or male, 18 to 65 years of age and in good general health
- Clinical diagnosis of stable mild to moderate atopic dermatitis
- Willing and able to follow study instructions and likely to complete all study requirements
Key exclusion criteria (3 listed)
- Severe or uncontrolled asthma
- Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of birth control
- Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
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 |
|---|---|---|
| RD047-26RD047-26 emollient gel | Device | RD047-26 |
Primary outcome
Investigator Global Assessment
Time frame: 2 weeks
Investigator Global Assessment of Atopic Dermatitis Severity
3 secondary outcomes
Investigator Pruritus Assessment
Time frame: 2 weeks
Subject Itch Assessment
Time frame: 2 weeks
Adverse Events
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
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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.
Zoe Draelos, M.D. principal investigator
Dermatology Consulting Services, High Point NC
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 RD047-26 in people with Atopic Dermatitis and Pruritus, run by Oculus Innovative Sciences, Inc. 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 4 inclusion and 3 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 30 May 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator Global Assessment (time frame: 2 weeks). 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 30 May 2012.