Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
- - Subjects will be included only, if 1.
- - Subjects may not be included, if 1.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Prof. Dr. Claus Bachert BVBA|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Martin Wagenmann, MD|
|Principal Investigator Affiliation||University pf Düsseldorf, Germany|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Allergic Rhinitis, Allergic Asthma, Allergic Conjunctivitis, Food Allergy|
An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each. In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only. The following Soluprick® allergens and control solutions will be evaluated: Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.
Active Comparator: Skin Prick Test TAPE
The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names.
Active Comparator: Skin Prick Test
The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes.
Diagnostic Test: - Skin Prick Test
Skin Prick Testing with inhalant allergens
Diagnostic Test: - Skin Prick Test TAPE
Skin Prick Testing with a Tape, integrating the allergens and needles
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Claus U Bachert, MD
For additional contact information, you can also visit the trial on clinicaltrials.gov.