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CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.
DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health.
CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.
DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health.
The purpose of the proposed study is to evaluate initial effects of the DiNaMo component on measures of undesired behavior intensity and related outcomes in a variety of conditions, such as atopic dermatitis and psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-100-004-A Psoriasis | Experimental |
| |
| CT-100-004-B Psoriasis | Sham Comparator |
| |
| CT-100-004-A Atopic Dermatitis | Experimental |
| |
| CT-100-004-B Atopic Dermatitis | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-100-004-A | Device | Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to strengthen inhibitory control. This intervention could help improve cognitive capabilities to help participants overcome the urge to scratch in response to an itch. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Pruritus Numerical Rating Scale | Change from baseline to Week 4 in the Peak Pruritus Numerical Rating Scale (PP-NRS) | Baseline to Week 4 |
| Change in Dermatology Life Quality Index | Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI) | Baseline to Week 4 |
| Change in Quality of Life symptoms | Change in QoL symptoms assessed with the PROMIS®-29+2 Profile v2.1 (PROMIS-29+2 Preference [PROPr]) scales (including mood, fatigue, pain interference, sleep, ability to participate in social functioning and cognitive function) from baseline to Week 4 | Baseline to Week 4 |
| Time in App | Engagement with the App as measured by daily time in the App | Baseline to Week 4 |
| Experience with Study App | Experience with the Study App as assessed by the User Experience Questionnaire after the Study App treatment period | Week 5 |
| Improved global rating of change | Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score at Week 4 | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events | Frequency of adverse events (AEs) | Baseline to Week 5 |
| Severity of Adverse Events | Severity of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
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| CT-100-004-B | Device | The CT-100-D-004-B Processing speed training component uses implicit training targeting processing speed. This intervention could help improve cognitive capabilities to help participants overcome the urge to scratch in response to an itch. |
|
| Baseline to Week 5 |
| Frequency of Serious Adverse Events | Frequency of Serious Adverse Events (AEs) | Baseline to Week 5 |
| Severity of Serious Adverse Events | Severity of Serious Adverse Events (AEs) | Baseline to Week 5 |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |