Atopic DermatitisADAPNCT05583019
Atopic Dermatitis With Accelerometry and Polysomnography (ADAP)
An observational study of Atopic Dermatitis and Eczema, run by SymmetryScience Group, Inc. at 1 site in United States.
Trial summary
The purpose of this research is to better understand how wrist-worn study devices that measure activity/motion ('accelerometry devices') can be used to assess scratching and sleep in participants aged 12-75 years, with and without Atopic Dermatitis (AD, eczema), in both a sleep laboratory (hotel) setting and in a… Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Eczema, Healthy
- What is being tested?
- GENEActiv Accelerometry Device, Centrepoint Insights Watch (CPIW) Accelerometry Device and Apple Watch Accelerometry Device
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 11 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy Participants over or including the age of 12 and under the age of 75 Participants with Atopic Dermatitis (AD) over or including the age of 12 and under the age of 75
Who may be able to join
- Atopic Dermatitis (AD) Participants:
- Participants aged ≥12 years of age and <75 years of age at Day 1.
- Written informed consent from participant or parent(s)/guardian(s) and assent from the participant (where assent is applicable).
- Participant (and parent(s)/guardian(s)) are willing and able to comply with study instructions, study visits, and procedures.
- Native English speakers or demonstrated fluency in English (participant; and parent(s)/guardian(s) as needed)
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
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- Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp.
- Have an Investigator's Static Global Assessment (ISGA) score of Mild (2), Moderate (3) or Severe (4) at the screening visit within 14 days of study enrollment.
- Have a minimum Peak Pruritus Numerical Rating Scale (PP-NRS) assessment score of 3 (out of 10).
- Wide Range Achievement Test-4 (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater (for ages ≥18 years only).
- Healthy (non-AD) Participants:
- Participants aged ≥12 years of age and <75 years of age at Day 1.
- Written informed consent from participant or parent(s)/guardian(s) and assent from the participant (where assent is applicable).
- Participant (and parent(s)/guardian(s)) are willing and able to comply with study instructions, study visits, and procedures.
- Native English speakers or demonstrated fluency in English (participant; and parent(s)/guardian(s) as needed)
- Does not have suspected or confirmed clinical diagnosis of AD (according to the criteria of Hanifin and Rajka).
- Have an ISGA score of Clear (0) or Almost Clear (1) at the screening visit within 14 days of study enrollment.
- WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater (for ages ≥18 years only).
Who cannot join
- Atopic Dermatitis (AD) Participants:
- 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 screening that precludes participant's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component).
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- AD affected surface areas are in a location of device placement.
- If participant has a history of angioedema or anaphylaxis and has had any anaphylactic reactions within the past 6 months.
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- Has unstable AD (Total BSA>40%).
- Has a significant active systemic or localized infection, including actively infected AD.
- Has recently (within 30 days of Day 1) participated in or is currently involved in another drug or device research study for AD.
- 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 employees directly involved in the conduct of the study.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of baseline as disclosed by participant during evaluation (for those participants over the age of 21).
- Is a female who is breastfeeding or pregnant, as disclosed by the participant.
- Current shift worker or travel across more than two time zones in the past 2 weeks, and/or during the study period.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
- Healthy (non-AD) Participants:
- Has any clinically significant medical disorder, condition, disease (including any active/potentially recurrent dermatological conditions (such as Netherton syndrome) or clinically significant finding at screening that precludes participant's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component).
- Has documented clinically diagnosed insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- If participant has a history of angioedema or anaphylaxis and has had any anaphylactic reactions within the past 6 months.
- Has recently (within 30 days of Day 1) participated in or is currently involved in another drug or device research study.
- 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 employees directly involved in the conduct of the study.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of baseline as disclosed by participant during evaluation (for those participants over the age of 21).
- Is a female who is breastfeeding or pregnant, as disclosed by the participant.
- Current shift worker or travel across more than two time zones in the past 2 weeks, and/or during the study period.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Device Quantification of Scratch and Sleep in Atopic Dermatitis With Accelerometry and Polysomnography (ADAP) Study
The purpose of this research is to better understand how wrist-worn study devices that measure activity/motion ('accelerometry devices') can be used to assess scratching and sleep in participants aged 12-75 years, with and without Atopic Dermatitis (AD, eczema), in both a sleep laboratory (hotel) setting and in a daily life/home setting. In this study, we will be using three different wrist devices to collect information: an Apple Watch Series 7, an Actigraph CentrePoint Insights Watch (CPIW) and a GENEActiv Original Watch. We will also compare the movement and sleep measurements recorded on the devices to thermal video and sleep assessments done in the sleep laboratory (hotel) as well as compare them to Patient Reported Outcome (PRO) assessments.
Read the detailed description
The general procedures include an initial intake appointment on day 1 (can be completed up to 3 days prior in case of scheduling conflicts), two overnight sleep laboratory visits, followed by approximately 12 days of wearing the devices during the participant's normal day-to-day activities and answering questions on a study-provided iPhone in the routine/home setting. The participant will be asked to complete questionnaires related to itch, sleep, pain, and overall Atopic Dermatitis (AD) severity each day, as relevant, and continuously wear wrist-worn accelerometry devices (as specified) during the study.
The study will begin with an initial in-laboratory intake appointment to verify study eligibility to participate in the study. We do our best to screen for study eligibility over the phone, but there are some eligibility requirements that must be assessed in person. This means that at the first appointment, there is a chance that the prospective participant will not be eligible to continue with the remainder of study activities. In the event that they are not eligible to continue at the first in- person appointment, they will be compensated a prorated study amount for their time.
Following the initial intake appointment, the participant will sleep overnight at the sleep laboratory/hotel. The participant will wear both the Apple Watch and the CentrePoint Insights Watch (CPIW) wrist devices, one of each, on both wrists. They will be asked to don the devices at least 6 hours before bedtime on the first overnight visit (day 1) and wear devices continuously (as specified) thereafter. The participant will be video recorded with an infra-red thermal camera (this video is de-identified, and only shows a heat map of their body, so facial features cannot be seen) during the sleep laboratory/hotel visits, wear the wrist accelerometry devices, and complete electronic questionnaires. In addition, on the second overnight in the sleep lab they will also have sensors placed on their head and limbs to monitor their sleep. Both nights, all three devices will also be next to the participant on the night stand, collecting information about their surroundings while they sleep. Upon the completion of the second night in the sleep laboratory (Days 1 and 2), they will then continue to wear wrist accelerometry devices and complete Patient Reported Outcome (PRO) questionnaires at home. The participants will be split into two cohorts (groups): Cohort 1 will wear both the CPIW and the GENEActiv device on both wrists and Cohort 2 will wear both the Apple Watch and GENEActiv device on both wrists. The participants will return to the laboratory on day 8 (+/- 2 days) to swap out devices. Cohort 1 will then wear both the Apple Watch and the GENEActiv device on both wrists and Cohort 2 will wear both the CPIW and GENEActiv device on both wrists for the remaining study days. At the conclusion of the at-home portion of the study, the participant will return the devices and assessments to the laboratory and complete final assessments.
- Conditions
- Atopic Dermatitis, Eczema, Healthy
- Being tested
- GENEActiv Accelerometry Device, Centrepoint Insights Watch (CPIW) Accelerometry Device, Apple Watch Accelerometry Device, Polysomnography, Videography
- Keywords
- Atopic Dermatitis, Eczema, Healthy
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENEActiv Accelerometry DeviceDevice
Also called GENEActiv Watch
a watch like wearable sensor
Centrepoint Insights Watch (CPIW) Accelerometry DeviceDevice
Also called Centrepoint Insights Watch (CPIW)
a watch like wearable sensor
Apple Watch Accelerometry DeviceDevice
Also called Apple Watch
a watch like wearable sensor
PolysomnographyDevice
Sleep monitor
VideographyDevice
Thermal Camera
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Those who do not have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Clear (0) or Almost Clear (1) on the Investigator's Static Global Assessment (ISGA) at intake. Receives: Device: GENEActiv Accelerometry Device; Device: Centrepoint Insights Watch (CPIW) Accelerometry Device; Device: Apple Watch Accelerometry Device; Device: Polysomnography; Device: Videography | |
| Mild Atopic Dermatitis (AD) | Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Mild (2) on the Investigator's Static Global Assessment (ISGA) at intake. Receives: Device: GENEActiv Accelerometry Device; Device: Centrepoint Insights Watch (CPIW) Accelerometry Device; Device: Apple Watch Accelerometry Device; Device: Polysomnography; Device: Videography | |
| Moderate Atopic Dermatitis (AD) | Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Moderate (3) on the Investigator's Static Global Assessment (ISGA) at intake. Receives: Device: GENEActiv Accelerometry Device; Device: Centrepoint Insights Watch (CPIW) Accelerometry Device; Device: Apple Watch Accelerometry Device; Device: Polysomnography; Device: Videography | |
| Severe Atopic Dermatitis (AD) | Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Severe (4) on the Investigator's Static Global Assessment (ISGA) at intake. Receives: Device: GENEActiv Accelerometry Device; Device: Centrepoint Insights Watch (CPIW) Accelerometry Device; Device: Apple Watch Accelerometry Device; Device: Polysomnography; Device: Videography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
One GENEActiv watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
Measured: 14 days +/- 2 days
Quantification of scratch using Centrepoint Insights Watches (CPIW) to assess triaxial accelerometry
One CPIW watch will be used on each wrist at a sampling rate of 128 Hz to measure movement in the x, y, and z direction.
Measured: 14 days +/- 2 days
Quantification of scratch using Apple Watches to assess triaxial accelerometry
One Apple Watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
Measured: 14 days +/- 2 days
Quantification of sleep occurrences using polysomnography
Polysomnography (PSG) will be used to report the number of sleep occurrences based on the scoring guide provided by the American Academy of Sleep Medicine (AASM).
Measured: 1 night
Sleep stage scoring using polysomnography
Polysomnography (PSG) will be used to report the appropriate sleep staging based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start27 Oct 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymmetryScience Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark B Moss, PhD, Principal investigator, SymmetryScience Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583019
- Sponsor's protocol ID
- SSG0001
- Acronym
- ADAP
- Status last verified
- Aug 2023
- First submitted
- 14 Oct 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device Quantification of Scratch and Sleep in Atopic Dermatitis With Accelerometry and Polysomnography (ADAP) Study
- ClinicalTrials.gov ID
- NCT05583019
- Acronym / sponsor ID
- ADAP / SSG0001
- Conditions
- Atopic Dermatitis, Eczema, Healthy
- Keywords
- Atopic Dermatitis, Eczema, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SymmetryScience Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to better understand how wrist-worn study devices that measure activity/motion ('accelerometry devices') can be used to assess scratching and sleep in participants aged 12-75 years, with and without Atopic Dermatitis (AD, eczema), in both a sleep laboratory (hotel) setting and in a daily life/home setting. In this study, we will be using three different wrist devices to collect information: an Apple Watch Series 7, an Actigraph CentrePoint Insights Watch (CPIW) and a GENEActiv Original Watch. We will also compare the movement and sleep measurements recorded on the devices to thermal video and sleep assessments done in the sleep laboratory (hotel) as well as compare them to Patient Reported Outcome (PRO) assessments.
Detailed description
The general procedures include an initial intake appointment on day 1 (can be completed up to 3 days prior in case of scheduling conflicts), two overnight sleep laboratory visits, followed by approximately 12 days of wearing the devices during the participant's normal day-to-day activities and answering questions on a study-provided iPhone in the routine/home setting. The participant will be asked to complete questionnaires related to itch, sleep, pain, and overall Atopic Dermatitis (AD) severity each day, as relevant, and continuously wear wrist-worn accelerometry devices (as specified) during the study.
The study will begin with an initial in-laboratory intake appointment to verify study eligibility to participate in the study. We do our best to screen for study eligibility over the phone, but there are some eligibility requirements that must be assessed in person. This means that at the first appointment, there is a chance that the prospective participant will not be eligible to continue with the remainder of study activities. In the event that they are not eligible to continue at the first in- person appointment, they will be compensated a prorated study amount for their time.
Following the initial intake appointment, the participant will sleep overnight at the sleep laboratory/hotel. The participant will wear both the Apple Watch and the CentrePoint Insights Watch (CPIW) wrist devices, one of each, on both wrists. They will be asked to don the devices at least 6 hours before bedtime on the first overnight visit (day 1) and wear devices continuously (as specified) thereafter. The participant will be video recorded with an infra-red thermal camera (this video is de-identified, and only shows a heat map of their body, so facial features cannot be seen) during the sleep laboratory/hotel visits, wear the wrist accelerometry devices, and complete electronic questionnaires. In addition, on the second overnight in the sleep lab they will also have sensors placed on their head and limbs to monitor their sleep. Both nights, all three devices will also be next to the participant on the night stand, collecting information about their surroundings while they sleep. Upon the completion of the second night in the sleep laboratory (Days 1 and 2), they will then continue to wear wrist accelerometry devices and complete Patient Reported Outcome (PRO) questionnaires at home. The participants will be split into two cohorts (groups): Cohort 1 will wear both the CPIW and the GENEActiv device on both wrists and Cohort 2 will wear both the Apple Watch and GENEActiv device on both wrists. The participants will return to the laboratory on day 8 (+/- 2 days) to swap out devices. Cohort 1 will then wear both the Apple Watch and the GENEActiv device on both wrists and Cohort 2 will wear both the CPIW and GENEActiv device on both wrists for the remaining study days. At the conclusion of the at-home portion of the study, the participant will return the devices and assessments to the laboratory and complete final assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Device: GENEActiv Accelerometry Device, Device: Centrepoint Insights Watch (CPIW) Accelerometry Device, Device: Apple Watch Accelerometry Device, Device: Polysomnography, Device: VideographyThose who do not have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Clear (0) or Almost Clear (1) on the Investigator's Static Global Assessment (ISGA) at intake. |
| Mild Atopic Dermatitis (AD) | – | Device: GENEActiv Accelerometry Device, Device: Centrepoint Insights Watch (CPIW) Accelerometry Device, Device: Apple Watch Accelerometry Device, Device: Polysomnography, Device: VideographyThose who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Mild (2) on the Investigator's Static Global Assessment (ISGA) at intake. |
| Moderate Atopic Dermatitis (AD) | – | Device: GENEActiv Accelerometry Device, Device: Centrepoint Insights Watch (CPIW) Accelerometry Device, Device: Apple Watch Accelerometry Device, Device: Polysomnography, Device: VideographyThose who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Moderate (3) on the Investigator's Static Global Assessment (ISGA) at intake. |
| Severe Atopic Dermatitis (AD) | – | Device: GENEActiv Accelerometry Device, Device: Centrepoint Insights Watch (CPIW) Accelerometry Device, Device: Apple Watch Accelerometry Device, Device: Polysomnography, Device: VideographyThose who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Severe (4) on the Investigator's Static Global Assessment (ISGA) at intake. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy Participants over or including the age of 12 and under the age of 75 Participants with Atopic Dermatitis (AD) over or including the age of 12 and under the age of 75
Key inclusion criteria (18 listed)
- Participants aged ≥12 years of age and <75 years of age at Day 1.
- Written informed consent from participant or parent(s)/guardian(s) and assent from the participant (where assent is applicable).
- Participant (and parent(s)/guardian(s)) are willing and able to comply with study instructions, study visits, and procedures.
- Native English speakers or demonstrated fluency in English (participant; and parent(s)/guardian(s) as needed)
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
Key exclusion criteria (27 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 screening that precludes participant's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component).
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- AD affected surface areas are in a location of device placement.
- If participant has a history of angioedema or anaphylaxis and has had any anaphylactic reactions within the past 6 months.
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 |
|---|---|---|
| GENEActiv Accelerometry DeviceAlso: GENEActiv Watcha watch like wearable sensor | Device | Healthy Control, Mild Atopic Dermatitis (AD), Moderate Atopic Dermatitis (AD), Severe Atopic Dermatitis (AD) |
| Centrepoint Insights Watch (CPIW) Accelerometry DeviceAlso: Centrepoint Insights Watch (CPIW)a watch like wearable sensor | Device | Healthy Control, Mild Atopic Dermatitis (AD), Moderate Atopic Dermatitis (AD), Severe Atopic Dermatitis (AD) |
| Apple Watch Accelerometry DeviceAlso: Apple Watcha watch like wearable sensor | Device | Healthy Control, Mild Atopic Dermatitis (AD), Moderate Atopic Dermatitis (AD), Severe Atopic Dermatitis (AD) |
| PolysomnographySleep monitor | Device | Healthy Control, Mild Atopic Dermatitis (AD), Moderate Atopic Dermatitis (AD), Severe Atopic Dermatitis (AD) |
| VideographyThermal Camera | Device | Healthy Control, Mild Atopic Dermatitis (AD), Moderate Atopic Dermatitis (AD), Severe Atopic Dermatitis (AD) |
Primary outcome
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
Time frame: 14 days +/- 2 days
One GENEActiv watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
Quantification of scratch using Centrepoint Insights Watches (CPIW) to assess triaxial accelerometry
Time frame: 14 days +/- 2 days
One CPIW watch will be used on each wrist at a sampling rate of 128 Hz to measure movement in the x, y, and z direction.
Quantification of scratch using Apple Watches to assess triaxial accelerometry
Time frame: 14 days +/- 2 days
One Apple Watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
Quantification of sleep occurrences using polysomnography
Time frame: 1 night
Polysomnography (PSG) will be used to report the number of sleep occurrences based on the scoring guide provided by the American Academy of Sleep Medicine (AASM).
Sleep stage scoring using polysomnography
Time frame: 1 night
Polysomnography (PSG) will be used to report the appropriate sleep staging based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- 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.
Mark B Moss, PhD principal investigator
SymmetryScience Group, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Eczema, run by SymmetryScience Group, Inc. 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 18 inclusion and 27 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 15 Aug 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry (time frame: 14 days +/- 2 days). The study lists 5 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 15 Aug 2023.