Atopic DermatitisPhase 4PADNCT05200403
Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
A Phase 4 study testing Crisaborole 2%, Accelerometry device for children and Accelerometry device for adult caregivers in people with Atopic Dermatitis, run by Boston University at 1 site in United States.
Trial summary
This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Read more about this study
- Who is it for?
- Ages 3 months to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Crisaborole 2%, Accelerometry device for children and Accelerometry device for adult caregivers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to 15 Feb 2024
- 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 3 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female participants aged between ≥3 months of age and ≤ 11 years of age at Day -7.
- Written informed consent from participant/parent(s)/guardian(s).
- Native English speakers or demonstrated fluency in English (as age appropriate).
- Participants and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, procedures, and device placement (devices will be optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment).
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.
- Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp and less than 40% BSA.
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- Have an Investigator's Static Global Assessment (ISGA) score of Mild (2) or Moderate (3) at the baseline visit.
- Have an Eczema Area and Severity Index (EASI) total score of ≥3 at Day -7.
- Have a minimum Observer Reported Itch Assessment score of 2 at Day -7 (ages 3 months - ≤ 5 years only) or a minimum Patient Reported Itch Severity Scale score of 2 (ages 6 years - ≤ 11 years old) at Day -7.
- Participant/parent(s)/guardian(s) agrees to refrain from applying diaper rash creams, lotions, ointments, powders, etc. where AD lesions are present, unless AD lesions are present where crisaborole cannot be applied (face within 1 or 2 fingers away from the mouth and hands/fingers).
- Participants must agree to refrain from applying crisaborole/vehicle to AD lesions on the fingers or hands or within 1 or 2 fingers away from the the mouth to prevent inadvertent ingestion of ointment.
- Primary caregiver of the enrolled child participant, between ≥18 years of age and ≤75 years of age.
- Able to understand and cooperate with study procedures and give informed consent.
- Native English speakers or demonstrated fluency in English
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- ISGA score of 0 or 1 of AD at the screening visit, and no reported diagnosis of Atopic Dermatitis
- WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater.
Who cannot join
- Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non-AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at baseline that precludes participant's participation in study activities.
- Participants who are on systemic corticosteroids or immunosuppressive agents within 28 days of Day -7 (V01).
- 3. Participants who are on topical AD treatment such as low-to-high-potency corticosteroids, TCIs, antihistamines, antibiotics, sodium hypochlorite-based products, antibacterial soaps, bleach baths, diaper rash creams, lotions, ointments, powders, light therapy, and use of bland emollients on or overlapping with treatable AD-involved areas within 7 days of Day -7 (V01), unless AD lesions are present where crisaborole cannot be applied (face within 1 or 2 fingers away from the of mouth and hands/fingers).
- Participants who are or have been on crisaborole treatment regimen in the past.
- Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
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- Participant has a known lack of efficacy to crisaborole.
- Participant scores <20 on the Childhood Asthma Control Test (ages 4-≤ 11) indicating poorly controlled asthma.
- If participant has a history of angioedema or anaphylaxis.
- Has a significant active systemic or localized infection, including actively infected.
- Has any planned surgical or medical procedure that would overlap with study participation.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
- Participants who are unable to wear at least one wrist device (one accelerometry device on at least one wrist).
- Has any clinically significant medical disorder, condition, disease or clinically significant finding at screening that precludes Caregivers participation in study activities (e.g., sleep apnea, narcolepsy, etc.)
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1drink=5ounces (150mL) wine, 12 ounces (360mL) of beer, or 1.5 ounces (45mL) of hard liquor) within 6 months of screening as disclosed by participant during evaluation.
- Current shift worker or travel across more than two time zones in the past 2 weeks, and/or during the study period.
- Has any planned surgical or medical procedure that would overlap with study participation.
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Boston University (BU)/Boston Medical Center (BMC) employees directly involved in the conduct of the study.
- Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
- A female who is pregnant.
- The primary caregiver or share the same domicile of another child who has previously been or is currently enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
BU CAMed Laboratory for Human Neurobiology
Boston, Massachusetts, 02118
About this study
Official title: Quantification of Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis on Crisaborole Ointment, 2%
This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited.
The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.
Read the detailed description
Approximately 270 children participants, age 3 months to ≤ 11 years, and their primary caregiver participants, for a total of 540 participants (270 pairs) will be randomized in 1:1 ratio to either Crisaborole (2% BID) or vehicle treatment and will be followed for 2 weeks. Participants will be asked to apply a thin even-layer of Crisaborole (2%) or vehicle twice daily (BID), excluding mouth, eyes, and vagina, per label, to all locations with active lesions (except for hands/fingers or within 1 to 2 fingers of the mouth to avoid inadvertent ingestion of ointment) and record location and time of application on the daily dosing form (provided by study staff, and as identified on the Dosing Record Sheet, breastfeeding women will be instructed to use the provided gloves when applying Crisaborole/vehicle). The study will be comprised of an initial screening/baseline visit for children participants who have an existing diagnosis of symptomatic AD, screened and enrolled in the study along with their primary caregivers after signing an informed consent (for parents/guardians and assent when appropriate).
Primary Objective:
- Evaluate the effects of Crisaborole on itch and night-time scratch (as measured by accelerometry/actigraphy and Observer Reported Itch Assessment (3 months to ≤ 11 years old)) in children with mild to moderate AD between the ages of 3 months to ≤ 11 years old.
Secondary Objectives:
- Evaluate the effects of Crisaborole on sleep in children ages 3 months to ≤ 11 years with mild to moderate AD.
- Evaluate sleep in primary caregivers.
- Evaluate the QoL measures in response to Crisaborole treatment (children 3 months to ≤ 11 years).
- Evaluate QoL measures in response to the child's treatment, to the parents/caregivers/families.
- Evaluate the effect of crisaborole treatment on AD signs, symptoms and severity in children ages 3 months to ≤ 11 years with mild to moderate AD.
The study will consist of a screening/baseline (in-laboratory) visit on Day -7 (V01), an in-laboratory visit Day 1 (V02), an in-laboratory visit on Day 2 (V03) for tape-striping, and Day 8 (V04) for a clinical assessment of the severity of the AD and a final in-laboratory visit on Day 15 (V05) for an assessment of the AD, tape-stripping, completion of ObsROs and return devices. Throughout the study, the participants and caregivers will wear accelerometry devices continuously (optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment; devices may be removed for short periods of time for such things as the purposes of bathing, etc.). Enrolled participants will be randomly assigned to each arm of the study. Participants may come in for an unscheduled visit as needed (i.e., to replace compound, etc.). All in-person study activities, including informed consent and pregnancy testing, will be completed at the Laboratory for Human Neurobiology, 650 Albany St X140, Boston, MA, 02118. All activities performed in the laboratory are accomplished in private rooms. Primary caregivers will be provided with ample time and a privacy curtain to change into a gown during assessment for exclusion of Atopic Dermatitis, and primary caregivers will accompany children during all activities to ensure participant privacy. All at-home study activities will be completed in the participants' home.
- Conditions
- Atopic Dermatitis
- Being tested
- Crisaborole 2%, Vehicle treatment, Accelerometry device for children, Accelerometry device for adult caregivers
- Keywords
- Night-time itch, Night-time scratch, Crisaborole, Children 3 months to ≤ 11 years, Accelerometry, Actigraphy, Quality of life, Vehicle
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisaborole 2%Drug
Also called EUCRISA
The adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks.
Vehicle treatmentDrug
Also called Nonmedicated ointment
The adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment).
Accelerometry device for childrenDevice
Children participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to <2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment.
Accelerometry device for adult caregiversDevice
Adult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Crisaborole 2% | Experimental | Adult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks. Receives: Drug: Crisaborole 2%; Device: Accelerometry device for children; Device: Accelerometry device for adult caregivers |
| Vehicle Arm | Active comparator | Adult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks. Receives: Drug: Vehicle treatment; Device: Accelerometry device for children; Device: Accelerometry device for adult caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children's Nighttime Scratching Episodes
The number of nighttime scratching episodes will be recorded on by accelerometry.
Measured: 2 weeks
Duration of Children's Nighttime Scratching Episodes
The duration of nighttime scratching episodes will be recorded on by accelerometry.
Measured: 2 weeks
Scratch Assessment by Adult Caregiver
Adult caregivers will fill out the Observer Reported Itch Assessment (ORIA) which is a single question assessment to assess the severity of the child participant's itch. The minimum score of "0" indicates "no itch" and the maximum score of "10" indicates "worst itch imaginable."
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start26 Jul 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Why it stopped: Funding was stoppped by grantor.
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.
- More trials run by Boston UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Kevin C Thomas, PhD, Principal investigator, BU School of Medicine, Anatomy and Neurobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200403
- Sponsor's protocol ID
- H-42240
- Other IDs
- H-42240
- Acronym
- PAD
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2022
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis on Crisaborole Ointment, 2%
- ClinicalTrials.gov ID
- NCT05200403
- Acronym / sponsor ID
- PAD / H-42240
- Conditions
- Atopic Dermatitis
- Keywords
- Night-time itch, Night-time scratch, Crisaborole, Children 3 months to ≤ 11 years, Accelerometry, Actigraphy, Quality of life, Vehicle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was stoppped by grantor.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited.
The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.
Detailed description
Approximately 270 children participants, age 3 months to ≤ 11 years, and their primary caregiver participants, for a total of 540 participants (270 pairs) will be randomized in 1:1 ratio to either Crisaborole (2% BID) or vehicle treatment and will be followed for 2 weeks. Participants will be asked to apply a thin even-layer of Crisaborole (2%) or vehicle twice daily (BID), excluding mouth, eyes, and vagina, per label, to all locations with active lesions (except for hands/fingers or within 1 to 2 fingers of the mouth to avoid inadvertent ingestion of ointment) and record location and time of application on the daily dosing form (provided by study staff, and as identified on the Dosing Record Sheet, breastfeeding women will be instructed to use the provided gloves when applying Crisaborole/vehicle). The study will be comprised of an initial screening/baseline visit for children participants who have an existing diagnosis of symptomatic AD, screened and enrolled in the study along with their primary caregivers after signing an informed consent (for parents/guardians and assent when appropriate).
Primary Objective:
- Evaluate the effects of Crisaborole on itch and night-time scratch (as measured by accelerometry/actigraphy and Observer Reported Itch Assessment (3 months to ≤ 11 years old)) in children with mild to moderate AD between the ages of 3 months to ≤ 11 years old.
Secondary Objectives:
- Evaluate the effects of Crisaborole on sleep in children ages 3 months to ≤ 11 years with mild to moderate AD.
- Evaluate sleep in primary caregivers.
- Evaluate the QoL measures in response to Crisaborole treatment (children 3 months to ≤ 11 years).
- Evaluate QoL measures in response to the child's treatment, to the parents/caregivers/families.
- Evaluate the effect of crisaborole treatment on AD signs, symptoms and severity in children ages 3 months to ≤ 11 years with mild to moderate AD.
The study will consist of a screening/baseline (in-laboratory) visit on Day -7 (V01), an in-laboratory visit Day 1 (V02), an in-laboratory visit on Day 2 (V03) for tape-striping, and Day 8 (V04) for a clinical assessment of the severity of the AD and a final in-laboratory visit on Day 15 (V05) for an assessment of the AD, tape-stripping, completion of ObsROs and return devices. Throughout the study, the participants and caregivers will wear accelerometry devices continuously (optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment; devices may be removed for short periods of time for such things as the purposes of bathing, etc.). Enrolled participants will be randomly assigned to each arm of the study. Participants may come in for an unscheduled visit as needed (i.e., to replace compound, etc.). All in-person study activities, including informed consent and pregnancy testing, will be completed at the Laboratory for Human Neurobiology, 650 Albany St X140, Boston, MA, 02118. All activities performed in the laboratory are accomplished in private rooms. Primary caregivers will be provided with ample time and a privacy curtain to change into a gown during assessment for exclusion of Atopic Dermatitis, and primary caregivers will accompany children during all activities to ensure participant privacy. All at-home study activities will be completed in the participants' home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisaborole 2% | Experimental | Drug: Crisaborole 2%, Device: Accelerometry device for children, Device: Accelerometry device for adult caregiversAdult caregivers of children participants will be asked to apply a thin even-layer of Crisaborole (2%) twice daily for 2 weeks. |
| Vehicle Arm | Active comparator | Drug: Vehicle treatment, Device: Accelerometry device for children, Device: Accelerometry device for adult caregiversAdult caregivers of children participants will be asked to apply a thin even-layer of vehicle treatment twice daily for 2 weeks. |
Who may qualify
- Ages
- 3 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female participants aged between ≥3 months of age and ≤ 11 years of age at Day -7.
- Written informed consent from participant/parent(s)/guardian(s).
- Native English speakers or demonstrated fluency in English (as age appropriate).
- Participants and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, procedures, and device placement (devices will be optional for those who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment).
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.
Key exclusion criteria (21 listed)
- Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non-AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at baseline that precludes participant's participation in study activities.
- Participants who are on systemic corticosteroids or immunosuppressive agents within 28 days of Day -7 (V01).
- 3. Participants who are on topical AD treatment such as low-to-high-potency corticosteroids, TCIs, antihistamines, antibiotics, sodium hypochlorite-based products, antibacterial soaps, bleach baths, diaper rash creams, lotions, ointments, powders, light therapy, and use of bland emollients on or overlapping with treatable AD-involved areas within 7 days of Day -7 (V01), unless AD lesions are present where crisaborole cannot be applied (face within 1 or 2 fingers away from the of mouth and hands/fingers).
- Participants who are or have been on crisaborole treatment regimen in the past.
- Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
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 |
|---|---|---|
| Crisaborole 2%Also: EUCRISAThe adult caregiver will apply a thin layer of Crisaborole 2% topically on their child participant twice a day for 2 weeks. | Drug | Crisaborole 2% |
| Vehicle treatmentAlso: Nonmedicated ointmentThe adult caregiver will apply a thin layer of the vehicle treatment topically on their child participant twice a day for 2 weeks. The vehicle treatment is made of excipients of crisaborole ointment (non-medicated ointment). | Drug | Vehicle Arm |
| Accelerometry device for childrenChildren participants will wear two wrist worn (or wrist worn AND ankle worn for 3 months up to <2 years) accelerometry devices. Devices will be optional for child participants who have active AD on location of device placement, with a minimum of at least one wrist device needed for enrollment. | Device | Crisaborole 2%, Vehicle Arm |
| Accelerometry device for adult caregiversAdult caregiver participants will wear two accelerometry devices (one on each wrist) and complete daily assessments related to scratching, sleeping habits, pain, AD severity, quality of life, and device comfort questionnaires. | Device | Crisaborole 2%, Vehicle Arm |
Primary outcome
Number of Children's Nighttime Scratching Episodes
Time frame: 2 weeks
The number of nighttime scratching episodes will be recorded on by accelerometry.
Duration of Children's Nighttime Scratching Episodes
Time frame: 2 weeks
The duration of nighttime scratching episodes will be recorded on by accelerometry.
Scratch Assessment by Adult Caregiver
Time frame: 2 weeks
Adult caregivers will fill out the Observer Reported Itch Assessment (ORIA) which is a single question assessment to assess the severity of the child participant's itch. The minimum score of "0" indicates "no itch" and the maximum score of "10" indicates "worst itch imaginable."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kevin C Thomas, PhD principal investigator
BU School of Medicine, Anatomy and Neurobiology
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 Crisaborole 2%, Accelerometry device for children and Accelerometry device for adult caregivers in people with Atopic Dermatitis, run by Boston University 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 17 inclusion and 21 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: stopped early, as of the sponsor's last update on 14 Mar 2025. 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. 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 14 Mar 2025). 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?
Number of Children's Nighttime Scratching Episodes (time frame: 2 weeks). 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?
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 14 Mar 2025.