Clinical trial NCT06275659: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
Official title: An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Atopic Dermatitis
Keywords: Itching
DiNaMo
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Peak Pruritus Numerical Rating Scale
timeFrame: Baseline to Week 4
measure: Change in Dermatology Life Quality Index
timeFrame: Baseline to Week 4
measure: Change in Quality of Life symptoms
timeFrame: Baseline to Week 4
measure: Time in App
timeFrame: Baseline to Week 4
measure: Experience with Study App
timeFrame: Week 5
measure: Improved global rating of change
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Frequency of Adverse Events
timeFrame: Baseline to Week 5
measure: Severity of Adverse Events
timeFrame: Baseline to Week 5
measure: Frequency of Serious Adverse Events
timeFrame: Baseline to Week 5
measure: Severity of Serious Adverse Events
timeFrame: Baseline to Week 5
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan
role: STUDY_DIRECTOR
References: