DermatitisPhase 3NCT00375713

Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

A Phase 3 study testing Levocetirizine, Cetirizine and Standard topical steroid (1% hydrocortisone) ointment in people with Dermatitis and Eczema, run by UCB Pharma at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Dermatitis, Eczema
What is being tested?: Levocetirizine, Cetirizine and Standard topical steroid (1% hydrocortisone) ointment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 466 participants
Where: 3 sitesSouth Korea
Study dates: Oct 2005to May 2006
Phase: Phase 3
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
Subjects who require and agree to the concomitant use of a topical steroid preparation.
Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
Written informed consent signed and dated by subject/legal guardian
Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Who cannot join

Subjects with a known hypersensitivity to cetirizine or levocetirizine
Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

Study site
Gyeunggi-do
Study site
Kyeonggi-Do
Study site
Seoul

Other trials in South Korea

About this study

Official title: A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema

Conditions: Dermatitis, Eczema
Being tested: Levocetirizine, Cetirizine, Placebo-Levocetirizine, Placebo-Cetirizine, Standard topical steroid (1% hydrocortisone) ointment
Keywords: Dermatitis, Eczema, Pruritus, Xyzal, Zyrtec, Levocetirizine, Cetirizine
Medical subject headings: Dermatitis, Eczema, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LevocetirizineDrug
Also called Xyzal®
1 Levocetirizine 5mg tablet per day before bedtime for 14 days
CetirizineDrug
Also called Zyrtec®
1 Cetirizine 10mg tablet per day before bedtime for 14 days.
Placebo-LevocetirizineDrug
1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
Placebo-CetirizineDrug
1 Placebo-Cetirizine tablet per day before bedtime for 14 days
Standard topical steroid (1% hydrocortisone) ointmentDrug
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Study groups in NCT00375713
Study group	Role	What they receive
Levocetirizine	Experimental	Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days Receives: Drug: Levocetirizine; Drug: Placebo-Cetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment
Cetirizine	Active comparator	Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days Receives: Drug: Cetirizine; Drug: Placebo-Levocetirizine; Drug: Standard topical steroid (1% hydrocortisone) ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.
Measured: Day 7 and 14

Secondary outcomes (3)

Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.
Measured: Baseline and at endpoint during the 14 day treatment period
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
Measured: At endpoint during the 14 day treatment period
Global Improvement at Endpoint During the 14 Day Treatment Period
Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
Measured: At endpoint during the 14 day treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005May 2006

First posted13 Sep 2006 (estimated)
Study startOct 2005
Primary completionMay 2006
Study completionMay 2006

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.
Other trials for DermatitisStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 466 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00375713
Sponsor's protocol ID: A00410
Status last verified: Dec 2009
First submitted: 12 Sep 2006
Last updated: 31 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

All Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema
ClinicalTrials.gov ID: NCT00375713
Acronym / sponsor ID: A00410
Conditions: Dermatitis, Eczema
Keywords: Dermatitis, Eczema, Pruritus, Xyzal, Zyrtec, Levocetirizine, Cetirizine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 466 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 13 Sep 2006 (estimated)
Results: Posted 14 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Levocetirizine	Experimental	Drug: Levocetirizine, Drug: Placebo-Cetirizine, Drug: Standard topical steroid (1% hydrocortisone) ointmentLevocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Cetirizine	Active comparator	Drug: Cetirizine, Drug: Placebo-Levocetirizine, Drug: Standard topical steroid (1% hydrocortisone) ointmentCetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
Subjects who require and agree to the concomitant use of a topical steroid preparation.
Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
Written informed consent signed and dated by subject/legal guardian
Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.

Key exclusion criteria (3 listed)

Subjects with a known hypersensitivity to cetirizine or levocetirizine
Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol

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
LevocetirizineAlso: Xyzal®1 Levocetirizine 5mg tablet per day before bedtime for 14 days	Drug	Levocetirizine
CetirizineAlso: Zyrtec®1 Cetirizine 10mg tablet per day before bedtime for 14 days.	Drug	Cetirizine
Placebo-Levocetirizine1 Placebo-Levocetirizine tablet per day before bedtime for 14 days	Drug	Cetirizine
Placebo-Cetirizine1 Placebo-Cetirizine tablet per day before bedtime for 14 days	Drug	Levocetirizine
Standard topical steroid (1% hydrocortisone) ointment1% hydrocortisone ointment, applied 2-3 times a day to all affected areas	Drug	Cetirizine, Levocetirizine

Primary outcome

Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
Time frame: Day 7 and 14
A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.

3 secondary outcomes

Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
Time frame: Baseline and at endpoint during the 14 day treatment period
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
Time frame: At endpoint during the 14 day treatment period
Global Improvement at Endpoint During the 14 Day Treatment Period
Time frame: At endpoint during the 14 day treatment period

Results and safety

Results posted to the registry on 14 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levocetirizine	232	212
Cetirizine	234	211

Primary outcome: Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).

Time frame: Day 7 and 14. Number. Unit: Participants

Measure	Levocetirizine n = 168	Cetirizine n = 172
Responder	131	134
Non-Responder	37	38

Levocetirizine vs Cetirizine: Difference in proportion of responders: 0.00069213 (95% CI -0.0875 to 0.0888)

Population analysed: The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levocetirizine	1 of 209 (0.5%)	0 of 209 (0%)	Not reported
Cetirizine	0 of 214 (0%)	5 of 214 (2.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Dermatitis

RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
Active, not recruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome

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.

Kevin Beh, MD study director

UCB Pharma

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levocetirizine, Cetirizine and Standard topical steroid (1% hydrocortisone) ointment in people with Dermatitis and Eczema, run by UCB Pharma at 3 sites in South Korea.

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 5 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 31 Aug 2011. 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 Korea. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 Oct 2009). 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?

Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). (time frame: Day 7 and 14). 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 NCT00375713.

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 31 Aug 2011.