Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis
NCT ID: NCT01948869
Last Updated: 2014-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis
NCT01691209
Assessment of Skin Tolerance and Efficacy of a Cosmetic Product After 5 Days of Use on Subjects With Atopic Dermatitis
NCT05807113
Efficacy and Safety of an Ectoine-containing Cream in the Treatment of Mild to Moderate Atopic Dermatitis
NCT01079897
Study of TDM-180935 in Atopic Dermatitis Patients
NCT06363461
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
NCT03672383
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phoenix II
Application over 29 days twice daily
Phoenix II (BAY81-2996)
Phoenix I
Application over 29 days twice daily
Phoenix I (BAY81-2996)
Untreated skin
Untreated skin areas of subjects will be observed over 29 days
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Phoenix II (BAY81-2996)
Phoenix I (BAY81-2996)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Münster, North Rhine-Westphalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-002569-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16960
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.