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

March 6, 2024 updated by: Click Therapeutics, Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10013
        • Click Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-100-004-A Psoriasis
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.
Sham Comparator: CT-100-004-B Psoriasis
Device: 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.
Experimental: CT-100-004-A Atopic Dermatitis
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.
Sham Comparator: CT-100-004-B Atopic Dermatitis
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak Pruritus Numerical Rating Scale
Time Frame: Baseline to Week 4
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
Time Frame: Baseline to Week 4
Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI)
Baseline to Week 4
Change in Quality of Life symptoms
Time Frame: Baseline to Week 4
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
Time Frame: Baseline to Week 4
Engagement with the App as measured by daily time in the App
Baseline to Week 4
Experience with Study App
Time Frame: Week 5
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
Time Frame: Baseline to Week 4
Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score at Week 4
Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Adverse Events
Time Frame: Baseline to Week 5
Frequency of adverse events (AEs)
Baseline to Week 5
Severity of Adverse Events
Time Frame: Baseline to Week 5
Severity of adverse events (AEs)
Baseline to Week 5
Frequency of Serious Adverse Events
Time Frame: Baseline to Week 5
Frequency of Serious Adverse Events (AEs)
Baseline to Week 5
Severity of Serious Adverse Events
Time Frame: Baseline to Week 5
Severity of Serious Adverse Events (AEs)
Baseline to Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Click Therapeutics, Inc.

Investigators

  • Study Director: Shaheen Lakhan, Click Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Actual)

February 23, 2024

Study Completion (Estimated)

March 18, 2024

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-100-D-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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