Dermatitis AtopicNCT05235724
A Study to Assess the Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of Participants From PEDISTAD Study (OBS15333; NCT03687359)
An observational study of Dermatitis Atopic, run by Sanofi at 7 sites in United States.
Trial summary
Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless sensor. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Dermatitis Atopic
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Feb 2022to 11 Jan 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Only participants enrolled in the OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites will be allowed to participate in this study.
Who may be able to join
- Participation in OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites.
- Enrolled in PEDISTAD, age more than or equal to 6 years to less than 12 years at the time of enrollment.
- Peak pruritus Numeric Rating Scale (NRS) last night more than or equal to 4 at screening.
- Participant must have home access to reliable and operational Wi-Fi and broadband internet at screening and throughout the study period.
- Participants/parents must have a device (mobile phone, tablet or computer) to record daily itch and sleep disturbance at screening and throughout the study period.
- Participant agrees to sleep by himself/herself (ie, with no other individuals or pets) in the monitored bedroom for the duration of the study (if not all times, at least 5 days a week for a minimum of 5 hours/night for a total of 16 weeks).
- Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.
Who cannot join
- Known history of a childhood sleep disorder such as parasomnias (sleep walking, talking, terrors, etc.), behavioral insomnia of childhood, or restless leg syndrome.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical University of South Carolina-Site Number:8400013
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center-Site Number:8400017
Cincinnati, Ohio, 45229
Amedica Research Institute, Inc.-Site Number:8400067
Hialeah, Florida, 33013
Eastern Research, Inc.-Site Number:8400032
Hialeah, Florida, 33013
Skin Research of South Florida, LLC-Site Number:8400018
Miami, Florida, 33173
C2 Research Center, LLC-Site Number:8400071
Montgomery, Alabama, 36117
Michigan Dermatology Institute-Site Number:8400059
Waterford, Michigan, 48328
About this study
Official title: Open-label 12-week Longitudinal Exploratory Study to Assess Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of PEDISTAD Patients
Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless sensor.
Secondary objective: To evaluate the feasibility of using the Emerald touchless sensor in a pediatric clinical trial setting.
Read the detailed description
16 weeks
- Conditions
- Dermatitis Atopic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subset of study-OBS15333 patients | As a sub-study of the OBS15333 pediatric AD registry (PEDISTAD), all participants in this study will be receiving standard care of therapies for moderate to severe AD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
Total no. of scratching events and scratching duration within each sleep stage each night will be calculated. Sleep efficiency: total time spent in a sleep stage (Stage 2, 3 or Rapid Eye Movement (REM) stage) relative to the total time in bed will be expressed as a %. Total time in bed: time from when the person enters the bed area and they become relatively static to waking up for the day. Correlation coefficient will be derived using data pairs from baseline through 12 weeks using evaluable data.
Measured: Week -1 (baseline) to week 12
Secondary outcomes (1)
Percentage (%) of nights with unusable data
The weekly average values (both baseline and post baseline, Emerald and participant reported) will be considered evaluable if they are based on at least 3 evaluable nightly values. Nights with unusable Emerald data are defined as nights with no data being collected by the device for any reason or the data collected were unevaluable.
Measured: Week -1 (baseline) to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start17 Feb 2022
- Primary completion11 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis AtopicStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235724
- Sponsor's protocol ID
- LPS17339
- Other IDs
- U1111-1269-6688
- Status last verified
- Jan 2023
- First submitted
- 1 Feb 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Rubin CJ, Lee LW, Assa'ad A, Lara-Corrales I, Katabi D, Rahul H, Ruan S, Krishna P, Hristov R, Chandross KJ, Gupta R, Ardeleanu M, Zhang A. Emerald Touchless Sensor Quantifies Nighttime Scratching and Sleep Quality in Children With Atopic Dermatitis: PEDISTAD EMERALD Study. Dermatol Ther (Heidelb). 2026 Aug 25. doi: 10.1007/s13555-026-01864-1. Online ahead of print.
PubMed 42642709
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label 12-week Longitudinal Exploratory Study to Assess Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of PEDISTAD Patients
- ClinicalTrials.gov ID
- NCT05235724
- Acronym / sponsor ID
- LPS17339
- Conditions
- Dermatitis Atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 11 Feb 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.
Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless sensor.
Secondary objective: To evaluate the feasibility of using the Emerald touchless sensor in a pediatric clinical trial setting.
Detailed description
16 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subset of study-OBS15333 patients | – | –As a sub-study of the OBS15333 pediatric AD registry (PEDISTAD), all participants in this study will be receiving standard care of therapies for moderate to severe AD. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Only participants enrolled in the OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites will be allowed to participate in this study.
Key inclusion criteria (7 listed)
- Participation in OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites.
- Enrolled in PEDISTAD, age more than or equal to 6 years to less than 12 years at the time of enrollment.
- Peak pruritus Numeric Rating Scale (NRS) last night more than or equal to 4 at screening.
- Participant must have home access to reliable and operational Wi-Fi and broadband internet at screening and throughout the study period.
- Participants/parents must have a device (mobile phone, tablet or computer) to record daily itch and sleep disturbance at screening and throughout the study period.
Key exclusion criteria (2 listed)
- Known history of a childhood sleep disorder such as parasomnias (sleep walking, talking, terrors, etc.), behavioral insomnia of childhood, or restless leg syndrome.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
Time frame: Week -1 (baseline) to week 12
Total no. of scratching events and scratching duration within each sleep stage each night will be calculated. Sleep efficiency: total time spent in a sleep stage (Stage 2, 3 or Rapid Eye Movement (REM) stage) relative to the total time in bed will be expressed as a %. Total time in bed: time from when the person enters the bed area and they become relatively static to waking up for the day. Correlation coefficient will be derived using data pairs from baseline through 12 weeks using evaluable data.
1 secondary outcome
Percentage (%) of nights with unusable data
Time frame: Week -1 (baseline) to week 12
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 31 Jan 2023.
- Derived from this study: PubMed 42642709Rubin CJ, Lee LW, Assa'ad A, Lara-Corrales I, Katabi D, Rahul H, Ruan S, Krishna P, Hristov R, Chandross KJ, Gupta R, Ardeleanu M, Zhang A. Emerald Touchless Sensor Quantifies Nighttime Scratching and Sleep Quality in Children With Atopic Dermatitis: PEDISTAD EMERALD Study. Dermatol Ther (Heidelb). 2026 Aug 25. doi: 10.1007/s13555-026-01864-1. Online ahead of print.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis Atopic, run by Sanofi at 7 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 2 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency (time frame: Week -1 (baseline) to week 12). 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 NCT05235724, 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 31 Jan 2023.