Atopic DermatitisPhase 2NCT00914186
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
A Phase 2 study testing TS022 in people with Atopic Dermatitis, run by Taisho Pharmaceutical R&D Inc. at 15 sites in United States.
Trial summary
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TS022
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2009to Oct 2010
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
- Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
- A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
- A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
- Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
- Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
- Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure
Who cannot join
- Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
- Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
- Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
- Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
- Inability or unwillingness to discontinue current AD treatment(s)
- Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Comprehensive Clinical Research
Berlin, New Jersey, 08009
J & S Studies
College Station, Texas, 77845
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Center for Clinical Studies
Houston, Texas, 77030
Ameriderm Research
Jacksonville, Florida, 32216
Ameriderm Research
Kissimmee, Florida, 34741
UCSD
La Jolla, California, 92037
FXM Research
Miramar, Florida, 33027
Ameriderm Research
Ormond Beach, Florida, 32174
Oregon Health and Science University
Portland, Oregon, 97239
Therapeutics Clinical Research
San Diego, California, 92123
Gwinnett Clinical Research
Snellville, Georgia, 30078
Haber Dermatology and Cosmetic Surgery, Inc
South Euclid, Ohio, 44118
Center for Clinical Studies
Webster, Texas, 77598
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.
Read the detailed description
(none provided)
- Conditions
- Atopic Dermatitis
- Being tested
- TS022, Vehicle
- Keywords
- Atopic Dermatitis, Pruritus
- 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.
TS022Drug
Lotion
VehicleDrug
Lotion
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
| TS-022 0.005% lotion | Experimental | Not described Receives: Drug: TS022 |
| TS-022 0.010% lotion | Experimental | Not described Receives: Drug: TS022 |
| TS-022 0.020% lotion | Experimental | Not described Receives: Drug: TS022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pruritis Visual Analog Scale (VAS)
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Measured: Baseline through Study Day 36 (Visit 7)
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms
Measured: Baseline through Study Day 36 (Visit 7)
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)
Measured: baseline through Study Day 36 (Visit 7)
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)
Measured: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.
Measured: baseline through Study Day 36 (Visit 7)
Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.
Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.
Measured: Study Day -7 through Study Day 22
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.
Measured: Baseline through Study Day 36 (Visit 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionOct 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nermina Nakas, MD, Study director, Clinsys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914186
- Sponsor's protocol ID
- TS022-US201
- Status last verified
- Nov 2011
- First submitted
- 28 May 2009
- Last updated
- 1 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus
- ClinicalTrials.gov ID
- NCT00914186
- Acronym / sponsor ID
- TS022-US201
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical R&D Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 17 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.
Detailed description
(none provided)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: Vehicle |
| TS-022 0.005% lotion | Experimental | Drug: TS022 |
| TS-022 0.010% lotion | Experimental | Drug: TS022 |
| TS-022 0.020% lotion | Experimental | Drug: TS022 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
- Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
- A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
- A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
- Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
Key exclusion criteria (6 listed)
- Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
- Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
- Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
- Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
- Inability or unwillingness to discontinue current AD treatment(s)
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 |
|---|---|---|
| TS022Lotion | Drug | TS-022 0.005% lotion, TS-022 0.010% lotion, TS-022 0.020% lotion |
| VehicleLotion | Drug | Vehicle |
Primary outcome
Change in Pruritis Visual Analog Scale (VAS)
Time frame: Baseline through Study Day 36 (Visit 7)
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
Time frame: Baseline through Study Day 36 (Visit 7)
Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
Time frame: baseline through Study Day 36 (Visit 7)
investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
Time frame: Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)
self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
Time frame: baseline through Study Day 36 (Visit 7)
The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.
Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.
Time frame: Study Day -7 through Study Day 22
Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
Time frame: Baseline through Study Day 36 (Visit 7)
Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nermina Nakas, MD study director
Clinsys
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TS022 in people with Atopic Dermatitis, run by Taisho Pharmaceutical R&D Inc. at 15 sites 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 7 inclusion and 6 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Nov 2011). 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?
Change in Pruritis Visual Analog Scale (VAS) (time frame: Baseline through Study Day 36 (Visit 7)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2011.