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

NCT06275659 | Completed

• 1 other identifier: CT-100-D-003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Atopic Dermatitis

Keywords

Itching; DiNaMo

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (4)

• Frequency of Adverse Events

  Baseline to Week 5

• Severity of Adverse Events

  Baseline to Week 5

• Frequency of Serious Adverse Events

  Baseline to Week 5

• Severity of Serious Adverse Events

  Baseline to Week 5

Study Arms (4)

CT-100-004-A Psoriasis

EXPERIMENTAL

Device: CT-100-004-A

CT-100-004-B Psoriasis

SHAM COMPARATOR

Device: CT-100-004-B

CT-100-004-A Atopic Dermatitis

EXPERIMENTAL

Device: CT-100-004-A

CT-100-004-B Atopic Dermatitis

SHAM COMPARATOR

Device: CT-100-004-B

Interventions

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.

CT-100-004-A Atopic Dermatitis; CT-100-004-A Psoriasis

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.

CT-100-004-B Atopic Dermatitis; CT-100-004-B Psoriasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Click Therapeutics, Inc.: lead

Study Sites (1)

Click Therapeutics

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Psoriasis; Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaheen Lakhan

  Click Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 23, 2024
• Study Start: December 4, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)