Dermatitis, Atopic Clinical Trial
— PhoenixOfficial title:
An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin
Verified date | August 2013 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Male or female Caucasians aged between 18 and 60 years - Patients with mild atopic dermatitis (AD) 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: - Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator - Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment - Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs [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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index | Up to 29 days | No | |
Other | Transepidermal water loss (TEWL) as a measure for skin barrier function | Up to 29 days | No | |
Other | Skin hydration by means of corneometry | Up to 29 days | No | |
Other | Erythema by means of chromametry | Up to 29 days | No | |
Other | Intensity of pruritus by means of visual analogue scale (VAS) | Up to 29 days | No | |
Secondary | Number of participants with abnormal vital signs | Vital signs consist of blood pressure, heart rate and body temperature. | Up to 10 weeks | Yes |
Secondary | Number of participants with adverse events as a measure of safety and tolerability | Up to 10 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
Terminated |
NCT04086121 -
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
|
Phase 2 | |
Recruiting |
NCT04011215 -
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
|
N/A | |
Completed |
NCT04635072 -
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
|
Early Phase 1 | |
Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
Completed |
NCT01945086 -
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT00541255 -
A Long-Term Examination of Asthma From Childhood Through Adolescence
|
||
Terminated |
NCT04990440 -
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT02900131 -
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients
|
Phase 2 | |
Completed |
NCT03568136 -
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
|
Phase 2 | |
Recruiting |
NCT01631617 -
Effects of Treatments on Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT03672383 -
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
|
N/A | |
Completed |
NCT03634345 -
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
|
Phase 1 | |
Enrolling by invitation |
NCT04761978 -
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
|
||
Completed |
NCT03663673 -
Effect of Different Skin Creams on TEWL
|
Phase 1 | |
Recruiting |
NCT05177744 -
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
|
||
Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
Completed |
NCT02637206 -
Skin Irritation Study of GSK2894512 Cream
|
Phase 1 | |
Completed |
NCT05544591 -
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A |