Atopic DermatitisPhase 2NCT00944632
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis
A Phase 2 study testing ZK 245186 in people with Atopic Dermatitis, run by Bayer at 3 sites in South Africa.
Trial summary
The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ZK 245186
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 3 sitesSouth Africa
- Study dates
- 15 Jul 2009to 15 Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
- mild to moderate atopic dermatitis at beginning of study
- wash-out periods for systemic and topical treatments for atopic dermatitis
- females must use effective contraception
Who cannot join
- pregnant or lactating women
- conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
- wide-spread atopic dermatitis requiring systemic treatment
- diagnosed with immunocompromised status
- skin diseases - other than atopic dermatitis - in the treatment area
- mental handicap or legally incompetent
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
PAREXEL International (Bloemfontein)
Bloemfontein, 9301
PAREXEL International (George)
George, 6529
PAREXEL International (Port Elizabeth)
Newton Park, 6045
About this study
Official title: Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis
The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.
- Conditions
- Atopic Dermatitis
- Being tested
- ZK 245186, Placebo (vehicle ointment)
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZK 245186Drug
Once daily topical non-occlusive application for up to 4 weeks
Placebo (vehicle ointment)Drug
Once daily topical non-occlusive application for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Zk 245186 0.01% ointment | Active comparator | Active treatment, lowest dose Receives: Drug: ZK 245186 |
| ZK 245186 0.03% ointment | Active comparator | Active comparator middle dose Receives: Drug: ZK 245186 |
| ZK 245186 0.1% ointment | Active comparator | Active comparator highest dose Receives: Drug: ZK 245186 |
| Vehicle ointment | Placebo comparator | Placebo comparator Receives: Drug: Placebo (vehicle ointment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
Measured: up to 4 weeks
Secondary outcomes (1)
Investigator's Global Assessment of target area
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study start15 Jul 2009
- Primary completion15 Sep 2010
- Study completion15 Sep 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT00944632
- Sponsor's protocol ID
- 14501
- Other IDs
- 1402942
- Status last verified
- Jun 2023
- First submitted
- 22 Jul 2009
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00944632
- Acronym / sponsor ID
- 14501
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2009 (actual)
- Primary completion
- 15 Sep 2010 (actual)
- Study completion
- 15 Sep 2010 (actual)
- First posted
- 23 Jul 2009 (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 determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zk 245186 0.01% ointment | Active comparator | Drug: ZK 245186Active treatment, lowest dose |
| ZK 245186 0.03% ointment | Active comparator | Drug: ZK 245186Active comparator middle dose |
| ZK 245186 0.1% ointment | Active comparator | Drug: ZK 245186Active comparator highest dose |
| Vehicle ointment | Placebo comparator | Drug: Placebo (vehicle ointment)Placebo comparator |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
- mild to moderate atopic dermatitis at beginning of study
- wash-out periods for systemic and topical treatments for atopic dermatitis
- females must use effective contraception
Key exclusion criteria (6 listed)
- pregnant or lactating women
- conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
- wide-spread atopic dermatitis requiring systemic treatment
- diagnosed with immunocompromised status
- skin diseases - other than atopic dermatitis - in the treatment area
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 |
|---|---|---|
| ZK 245186Once daily topical non-occlusive application for up to 4 weeks | Drug | ZK 245186 0.03% ointment, ZK 245186 0.1% ointment, Zk 245186 0.01% ointment |
| Placebo (vehicle ointment)Once daily topical non-occlusive application for up to 4 weeks | Drug | Vehicle ointment |
Primary outcome
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation
Time frame: up to 4 weeks
1 secondary outcome
Investigator's Global Assessment of target area
Time frame: up to 4 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 7 Jun 2023.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZK 245186 in people with Atopic Dermatitis, run by Bayer at 3 sites in South Africa.
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 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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. Some participants in this study may receive a placebo. 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?
Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation (time frame: up to 4 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 7 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.