Psoriasis Clinical Trial
— DECODE-ScratchOfficial title:
Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
| NCT number | NCT06448689 |
| Other study ID # | AG0001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 12, 2024 |
| Est. completion date | June 2026 |
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | June 2026 |
| Est. primary completion date | March 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 14 Years to 70 Years |
| Eligibility | Inclusion criteria for participants with atopic dermatitis: - At least 14 years old - Less than 70 years old - Clinical diagnosis of Atopic Dermatitis - Peak Pruritis NRS score > 1 Inclusion criteria for participants with psoriasis: - At least 18 years old - Less than 70 years old - Clinical diagnosis of plaque psoriasis - At least a peak pruritis PNRS of 4 - Itch is caused by psoriasis, as determined by clinician Exclusion Criteria: - Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...) - Movement disorder - Flare or infection on the wrist - Infected atopic dermatitis or psoriasis lesions - Pregnant or lactating women - Shift workers or participants with jetlag - Current diagnosis of depression |
| Country | Name | City | State |
|---|---|---|---|
| France | AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| ActiGraph L.L.C |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Scratch Movements | To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor | 14 days | |
| Primary | Sleep Time | To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor | 14 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
|
Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
|
||
| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
|
||
| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
|
N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
|
N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
|
||
| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
|
||
| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
|
Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
|
Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
|
Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
|
||
| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
|
Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
|
||
| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
|
Phase 2 |