Atopic DermatitisPhase 4NCT00884325
Management of Pruritus With Xyzal in Atopic Dermatitis
A Phase 4 study testing Levocetirizine dihydrochloride (Xyzal) in people with Atopic Dermatitis and Pruritus, run by Derm Research, PLLC at 1 site in United States.
Trial summary
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Pruritus
- What is being tested?
- Levocetirizine dihydrochloride (Xyzal)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient, male or female subjects of any race, at least 18 years of age.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study. A female is considered of childbearing potential unless she is:
- postmenopausal for at least 12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration.
- Reliable methods of contraception are:
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- hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
- barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
- vasectomized partner. [Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
- Definitive diagnosis of atopic dermatitis as per Rajka-Hanifin criteria.
- Visual Analog Scale (VAS) pruritus score of 6 cm or more (moderate to severe itching) at baseline.
- Willing to refrain from other antihistamines and topical steroids and topical immunomodulators for the duration of the study.
- Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance and Portability Accountability Act (HIPAA) Authorization forms.
Who cannot join
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Requiring oral treatment for their atopic dermatitis apart from oral antihistamines
- History of hypersensitivity or idiosyncratic reaction to to any component of the test medication , or to cetirizine.
- Atopic Dermatitis triggered by an unavoidable irritant/allergen.
- Skin disease/disorder that might interfere with the diagnosis or evaluation of atopic dermatitis (e.g., erythroderma, skin infection on the affected area, etc.)
- Non-compliance with the proper wash-out periods for prohibited medications.
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- Uncontrolled chronic disease such as diabetes
- The presence of renal disease with mild, moderate or severe renal impairment
- Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.
- Clinically significant alcohol or drug abuse, in the opinion of the Investigator.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Participation in an investigational drug study within 30 days of the Baseline Visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.
- Conditions
- Atopic Dermatitis, Pruritus
- Being tested
- Levocetirizine dihydrochloride (Xyzal), placebo
- Keywords
- Itching, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levocetirizine dihydrochloride (Xyzal)Drug
Also called Xyzal
One tablet 5 mg taken orally at night for 28 days
placeboDrug
One tablet taken orally at night for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Xyzal | Experimental | Not described Receives: Drug: Levocetirizine dihydrochloride (Xyzal) |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus VAS Scores at Baseline, Week 2 and Week 4
Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.
Measured: Baseline - Week 2-Week 4
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30)
Measured: Baseline - Week 2 - Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
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 Atopic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, Leon Kircik, M.D., Derm Research, PLLC
- Investigators
- Leon H. Kircik, M.D., Principal investigator, DermResearch, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884325
- Sponsor's protocol ID
- XYZ0801
- Status last verified
- Aug 2013
- First submitted
- 17 Apr 2009
- Last updated
- 16 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hannuksela M, Kalimo K, Lammintausta K, Mattila T, Turjanmaa K, Varjonen E, Coulie PJ. Dose ranging study: cetirizine in the treatment of atopic dermatitis in adults. Ann Allergy. 1993 Feb;70(2):127-33.
PubMed 8430920
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pruritus With Xyzal in Atopic Dermatitis in a Randomized, Double-Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00884325
- Acronym / sponsor ID
- XYZ0801
- Conditions
- Atopic Dermatitis, Pruritus
- Keywords
- Itching, Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Posted 16 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xyzal | Experimental | Drug: Levocetirizine dihydrochloride (Xyzal) |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Outpatient, male or female subjects of any race, at least 18 years of age.
- Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study. A female is considered of childbearing potential unless she is:
- Reliable methods of contraception are:
- Definitive diagnosis of atopic dermatitis as per Rajka-Hanifin criteria.
- Visual Analog Scale (VAS) pruritus score of 6 cm or more (moderate to severe itching) at baseline.
Key exclusion criteria (12 listed)
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Requiring oral treatment for their atopic dermatitis apart from oral antihistamines
- History of hypersensitivity or idiosyncratic reaction to to any component of the test medication , or to cetirizine.
- Atopic Dermatitis triggered by an unavoidable irritant/allergen.
- Skin disease/disorder that might interfere with the diagnosis or evaluation of atopic dermatitis (e.g., erythroderma, skin infection on the affected area, etc.)
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 dihydrochloride (Xyzal)Also: XyzalOne tablet 5 mg taken orally at night for 28 days | Drug | Xyzal |
| placeboOne tablet taken orally at night for 28 days | Drug | Placebo |
Primary outcome
Pruritus VAS Scores at Baseline, Week 2 and Week 4
Time frame: Baseline - Week 2-Week 4
Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities.
1 secondary outcome
Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
Time frame: Baseline - Week 2 - Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8430920Hannuksela M, Kalimo K, Lammintausta K, Mattila T, Turjanmaa K, Varjonen E, Coulie PJ. Dose ranging study: cetirizine in the treatment of atopic dermatitis in adults. Ann Allergy. 1993 Feb;70(2):127-33.
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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.
Leon H. Kircik, M.D. principal investigator
DermResearch, PLLC
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 dihydrochloride (Xyzal) in people with Atopic Dermatitis and Pruritus, run by Derm Research, PLLC at 1 site in United States.
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 13 inclusion and 12 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 16 Aug 2013. 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 United States. 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 16 Aug 2013). 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 VAS Scores at Baseline, Week 2 and Week 4 (time frame: Baseline - Week 2-Week 4). 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 NCT00884325, 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 16 Aug 2013.