PruritusPhase 4LAWAFNCT01586091
Safety Study of Levocetirizine and Fexofenadine
A Phase 4 study testing Levocetirizine Oral Tablet and Fexofenadine 60 Mg Oral Tablet in people with Pruritus and Chronic Urticaria, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus, Chronic Urticaria, Allergic Rhinitis
- What is being tested?
- Levocetirizine Oral Tablet and Fexofenadine 60 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study
Who cannot join
- None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Berlin Charité, Department of Dermatology and Allergy
Berlin, 10117
About this study
Official title: Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal, Flare and Itch Response
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled study with intra-individual comparison of the histamine induced wheal and flare reaction. In September 2009, Fexofenadine was approved as an antihistamine against allergies in Japan and it is currently used widely. It has been approved in 120 countries, including the US, UK, France and Germany [11]. In Europe and the United States, fexofenadine is marketed at 120 mg once daily for allergic rhinitis and 180mg once daily for urticaria. In Japan, fexofenadine is marketed at 60 mg twice daily for both conditions. But is this dosage regimen as effective as levocetirizine, 5 mg once daily? The above described study from Takahashi et al, comparing 60 mg twice daily versus cetirizine 10 mg once daily suggests that it is not [4]. The aim of the study is to compare the efficacy and consistency of action of levocetirizine 5 mg once daily with fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal, flare and itch response. Furthermore, we would like to investigate whether a different between Japanese and Caucasian exists or not. Each volunteer will receive the study medication at time point 0 and 12 hour later. Skin Prick Test (SPT) will be performed in each volunteer using histamine (10 mg/ml), 15 minutes before drug admission (baseline) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours afterwards. Volumetric optical scanning system and infrared camera will be used for objective evaluation of the wheal- and flare reduction. Additionally, measurement of the erythema diameter with a transparent ruler will be performed. The subjective intensity of itching will be assessed using a Visual Analogue Scale (VAS). To relate the pharmacokinetics of the drugs to their pharmacodynamics, blood samples for assay of drug concentrations will be taken at baseline and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours later. Subjects will undergo the same procedure on three separate occasions to receive each treatment option. The options are: placebo at time 0 hours + placebo at 12 hours, Levocetirizine 5mg at time 0 hours + placebo at 12 hours or fexofenadine 60mg at time 0 hours + fexofenadine 60mg at 12 hours. There will be a washout period of at least 6 days between the treatments.
- Conditions
- Pruritus, Chronic Urticaria, Allergic Rhinitis
- Being tested
- Levocetirizine Oral Tablet, Fexofenadine 60 Mg Oral Tablet, Placebo Oral Tablet
- Medical subject headings
- Pruritus, Chronic Urticaria, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine Oral TabletDrug
Fexofenadine 60 Mg Oral TabletDrug
Also called Telfast
Placebo Oral TabletDrug
Also called Lichtenstein
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo per os at time 0 hours + placebo per os at 12 hours. Receives: Drug: Placebo Oral Tablet |
| Levocetirizin | Active comparator | Levocetirizin 5mg at time 0 and placebo per os at 12 hours Receives: Drug: Levocetirizine Oral Tablet; Drug: Placebo Oral Tablet |
| Fexofenadine | Active comparator | Fexofenadine 60mg per os at time 0 hours + fexofenadine 60mg per os at 12 hours Receives: Drug: Fexofenadine 60 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus as Assessed by the VAS Score
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point.
Measured: up to 10 minutes after skin prick test performed 24 hours after drug administration
Flaire Diameter (mm)
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.
Measured: 24 hours per treatment
Wheal Volume (cm3)
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).
Measured: 24 hours per treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Metz, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, MD, Principal investigator, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586091
- Sponsor's protocol ID
- 2010-022747-38
- Acronym
- LAWAF
- Status last verified
- Sep 2019
- First submitted
- 23 Apr 2012
- Last updated
- 4 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data will not be available.
Publications
Schoepke N, Church MK, Maurer M. The inhibition by levocetirizine and fexofenadine of the histamine-induced wheal and flare response in healthy Caucasian and Japanese volunteers. Acta Derm Venereol. 2013 May;93(3):286-93. doi: 10.2340/00015555-1490.
PubMed 23147964
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg Once Daily With Fexofenadine 60 mg Twice Daily in the Histamine Induced Wheal, Flare and Itch Response
- ClinicalTrials.gov ID
- NCT01586091
- Acronym / sponsor ID
- LAWAF / 2010-022747-38
- Conditions
- Pruritus, Chronic Urticaria, Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Posted 4 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.
Detailed description
This will be a randomized, double-blind, placebo-controlled study with intra-individual comparison of the histamine induced wheal and flare reaction. In September 2009, Fexofenadine was approved as an antihistamine against allergies in Japan and it is currently used widely. It has been approved in 120 countries, including the US, UK, France and Germany [11]. In Europe and the United States, fexofenadine is marketed at 120 mg once daily for allergic rhinitis and 180mg once daily for urticaria. In Japan, fexofenadine is marketed at 60 mg twice daily for both conditions. But is this dosage regimen as effective as levocetirizine, 5 mg once daily? The above described study from Takahashi et al, comparing 60 mg twice daily versus cetirizine 10 mg once daily suggests that it is not [4]. The aim of the study is to compare the efficacy and consistency of action of levocetirizine 5 mg once daily with fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal, flare and itch response. Furthermore, we would like to investigate whether a different between Japanese and Caucasian exists or not. Each volunteer will receive the study medication at time point 0 and 12 hour later. Skin Prick Test (SPT) will be performed in each volunteer using histamine (10 mg/ml), 15 minutes before drug admission (baseline) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours afterwards. Volumetric optical scanning system and infrared camera will be used for objective evaluation of the wheal- and flare reduction. Additionally, measurement of the erythema diameter with a transparent ruler will be performed. The subjective intensity of itching will be assessed using a Visual Analogue Scale (VAS). To relate the pharmacokinetics of the drugs to their pharmacodynamics, blood samples for assay of drug concentrations will be taken at baseline and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours later. Subjects will undergo the same procedure on three separate occasions to receive each treatment option. The options are: placebo at time 0 hours + placebo at 12 hours, Levocetirizine 5mg at time 0 hours + placebo at 12 hours or fexofenadine 60mg at time 0 hours + fexofenadine 60mg at 12 hours. There will be a washout period of at least 6 days between the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo per os at time 0 hours + placebo per os at 12 hours. |
| Levocetirizin | Active comparator | Drug: Levocetirizine Oral Tablet, Drug: Placebo Oral TabletLevocetirizin 5mg at time 0 and placebo per os at 12 hours |
| Fexofenadine | Active comparator | Drug: Fexofenadine 60 Mg Oral TabletFexofenadine 60mg per os at time 0 hours + fexofenadine 60mg per os at 12 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study
Key exclusion criteria (3 listed)
- None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
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 |
|---|---|---|
| Levocetirizine Oral Tablet | Drug | Levocetirizin |
| Fexofenadine 60 Mg Oral TabletAlso: Telfast | Drug | Fexofenadine |
| Placebo Oral TabletAlso: Lichtenstein | Drug | Levocetirizin, Placebo |
Primary outcome
Pruritus as Assessed by the VAS Score
Time frame: up to 10 minutes after skin prick test performed 24 hours after drug administration
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point.
Flaire Diameter (mm)
Time frame: 24 hours per treatment
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.
Wheal Volume (cm3)
Time frame: 24 hours per treatment
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23147964Schoepke N, Church MK, Maurer M. The inhibition by levocetirizine and fexofenadine of the histamine-induced wheal and flare response in healthy Caucasian and Japanese volunteers. Acta Derm Venereol. 2013 May;93(3):286-93. doi: 10.2340/00015555-1490.
- Individual participant dataSharing planned: No. Individual participant data will not be available.
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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.
Marcus Maurer, MD principal investigator
Charite Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine Oral Tablet and Fexofenadine 60 Mg Oral Tablet in people with Pruritus and Chronic Urticaria, run by Charite University, Berlin, Germany 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 1 inclusion and 3 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 4 Oct 2019. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pruritus as Assessed by the VAS Score (time frame: up to 10 minutes after skin prick test performed 24 hours after drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01586091, which also lists 1 linked publication.
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 4 Oct 2019.