Dermatitis, AtopicPhoenix IINCT01948869
Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis
A study testing Phoenix II (BAY81-2996) and Phoenix I (BAY81-2996) in people with Dermatitis, Atopic, run by Bayer at 1 site in Germany.
Trial summary
The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Phoenix II (BAY81-2996) and Phoenix I (BAY81-2996)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jun 2014
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female Caucasians aged between 18 and 60 years
- Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
- Skin type I - IV according to Fitzpatrick
- Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and </= 12) at Baseline
- Acute symptom of pruritus at Baseline
Who cannot join
- Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
- Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
- Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug [NSAIDs])
- Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- UV-therapy or the use of solarium within 30 days before screening as well as during the trial
- Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin
The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
- Conditions
- Dermatitis, Atopic
- Being tested
- Phoenix II (BAY81-2996), Phoenix I (BAY81-2996)
- Keywords
- Phoenix, Mild atopic dermatitis, efficacy, safety
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phoenix II (BAY81-2996)Device
Phoenix I (BAY81-2996)Device
| Study group | Role | What they receive |
|---|---|---|
| Phoenix II | Experimental | Application over 29 days twice daily Receives: Device: Phoenix II (BAY81-2996) |
| Phoenix I | Active comparator | Application over 29 days twice daily Receives: Device: Phoenix I (BAY81-2996) |
| Untreated skin | No intervention | Untreated skin areas of subjects will be observed over 29 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Measured: Up to 29 days
Secondary outcomes (6)
Number of subjects with abnormal vital signs
Vital signs consist of blood pressure, heart rate, and body temperature
Measured: Up to 10 weeks
Number of patients with adverse events as a measure of safety and tolerability
Measured: Up to 10 weeks
Erythema by means of chromametry
Measured: Up to 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function
Measured: Up to 29 days
Skin hydration by means of corneometry
Measured: Up to 29 days
Intensity of pruritus by means of visual analogue scale (VAS)
Measured: Up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948869
- Sponsor's protocol ID
- 16960
- Other IDs
- 2013-002569-20
- Acronym
- Phoenix II
- Status last verified
- Aug 2014
- First submitted
- 19 Sep 2013
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin
- ClinicalTrials.gov ID
- NCT01948869
- Acronym / sponsor ID
- Phoenix II / 16960
- Conditions
- Dermatitis, Atopic
- Keywords
- Phoenix, Mild atopic dermatitis, efficacy, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Sep 2013 (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 study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phoenix II | Experimental | Device: Phoenix II (BAY81-2996)Application over 29 days twice daily |
| Phoenix I | Active comparator | Device: Phoenix I (BAY81-2996)Application over 29 days twice daily |
| Untreated skin | No intervention | –Untreated skin areas of subjects will be observed over 29 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female Caucasians aged between 18 and 60 years
- Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
- Skin type I - IV according to Fitzpatrick
- Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and </= 12) at Baseline
- Acute symptom of pruritus at Baseline
Key exclusion criteria (6 listed)
- Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
- Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
- Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug [NSAIDs])
- Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- UV-therapy or the use of solarium within 30 days before screening as well as during the trial
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 |
|---|---|---|
| Phoenix II (BAY81-2996) | Device | Phoenix II |
| Phoenix I (BAY81-2996) | Device | Phoenix I |
Primary outcome
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Time frame: Up to 29 days
6 secondary outcomes
Number of subjects with abnormal vital signs
Time frame: Up to 10 weeks
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Up to 10 weeks
Erythema by means of chromametry
Time frame: Up to 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function
Time frame: Up to 29 days
Skin hydration by means of corneometry
Time frame: Up to 29 days
Intensity of pruritus by means of visual analogue scale (VAS)
Time frame: Up to 29 days
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 7 Aug 2014.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phoenix II (BAY81-2996) and Phoenix I (BAY81-2996) in people with Dermatitis, Atopic, run by Bayer at 1 site in Germany.
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 5 inclusion and 6 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 7 Aug 2014. 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 Germany. 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.
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?
Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index (time frame: Up to 29 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 7 Aug 2014.