Atopic Dermatitis, Pruritus
Conditions
Keywords
Itching, Atopic Dermatitis
Brief 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. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.
Interventions
DRUGLevocetirizine dihydrochloride (Xyzal)
One tablet 5 mg taken orally at night for 28 days
DRUGplacebo
One tablet taken orally at night for 28 days
Sponsors
UCB Pharma
Derm Research, PLLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus VAS Scores at Baseline, Week 2 and Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | Baseline - Week 2 - 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) |
Countries
United States
Participant flow
Recruitment details
Subjects with uncomplicated atopic dermatitis were recruited form the PI's medical practice. Recruitment occurred from March 2009 through December 2009.
Pre-assignment details
45 subjects were consented but 5 were screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Xyzal | 20 |
| Subjects Receiving Placebo | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not provided | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Subjects Receiving Placebo | Subjects Receiving Xyzal | Total |
|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 1 participants | 1 participants | 2 participants |
| Age Categorical Between 18 and 65 years | 18 participants | 19 participants | 37 participants |
| Age Continuous | 41.1 years FULL_RANGE 14.8 | 41.1 years FULL_RANGE 14.6 | 41.1 years FULL_RANGE 14.6 |
| Gender Female | 12 participants | 14 participants | 26 participants |
| Gender Male | 7 participants | 6 participants | 13 participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 20 | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline - Week 2-Week 4
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects Receiving Xyzal | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Week 4 | 4.15 units on a scale |
| Subjects Receiving Xyzal | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Week 2 | 6.10 units on a scale |
| Subjects Receiving Xyzal | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Baseline | 7.8 units on a scale |
| Subjects Receiving Placebo | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Baseline | 7.5 units on a scale |
| Subjects Receiving Placebo | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Week 2 | 5.9 units on a scale |
| Subjects Receiving Placebo | Pruritus VAS Scores at Baseline, Week 2 and Week 4 | Week 4 | 6.4 units on a scale |
Secondary
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)
Time frame: Baseline - Week 2 - Week 4
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Subjects Receiving Xyzal | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Week 4 | 2.00 units on a scale |
| Subjects Receiving Xyzal | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Baseline | 7.5 units on a scale |
| Subjects Receiving Xyzal | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Week 2 | 3.5 units on a scale |
| Subjects Receiving Placebo | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Week 4 | 4.00 units on a scale |
| Subjects Receiving Placebo | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Baseline | 8.00 units on a scale |
| Subjects Receiving Placebo | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 | DLQI - Week 2 | 5.5 units on a scale |