An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis

Psoriasis Clinical Trial

Official title:

An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06275659
• Other study ID #: CT-100-D-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: March 18, 2024

Study information

• Verified date: March 2024
• Source: Click Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 18, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fluent in written and spoken English, confirmed by ability to read, understand and sign the informed consent form (ICF).

• Lives in the United States.

• Aged 18 years or older.

• Itch NRS = 4 during screening.

• Meets indication-specific inclusion criteria (see Appendix 1), as reported by the study participant with adequate clinical documentation. (Documentation to be provided to the study team upon request.)

• Has an active email address and is willing and able to receive and respond to email messages.

• Has access to an internet connection during the study duration.

• Willing and able to comply with the study protocol and assessments.

• Is the sole user of an iPhone with an iPhone operating system (OS) 14 or later or a smartphone with an Android OS 10 or later for the duration of the study.

• Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone.

Exclusion Criteria:

• Pregnant or planning to become pregnant.

• Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based, reaction-time-based activity per investigator judgment.

• Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder or severe personality disorders).

• Psychiatric hospitalization in the past 6 months.

• Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months.

• Initiation or change in primary-disease-specific medication within 30 days prior to entering the study.

• Self-reported substance-use disorder within the past 1 year.

• Currently experiencing a skin infection.

• Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the 7-week study period.

• Anticipating a change in current pharmacological or psychotherapy treatment regimen during the 7-week study period.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

Device:
• CT-100-004-A
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.
• CT-100-004-B
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.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Dermatology Life Quality Index	Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI)	Baseline to Week 4
Primary	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
Primary	Time in App	Engagement with the App as measured by daily time in the App	Baseline to Week 4
Primary	Experience with Study App	Experience with the Study App as assessed by the User Experience Questionnaire after the Study App treatment period	Week 5
Primary	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
Secondary	Frequency of Adverse Events	Frequency of adverse events (AEs)	Baseline to Week 5
Secondary	Severity of Adverse Events	Severity of adverse events (AEs)	Baseline to Week 5
Secondary	Frequency of Serious Adverse Events	Frequency of Serious Adverse Events (AEs)	Baseline to Week 5
Secondary	Severity of Serious Adverse Events	Severity of Serious Adverse Events (AEs)	Baseline to Week 5