PsoriasisNCT06275659
An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
A study testing CT-100-004-A and CT-100-004-B in people with Psoriasis and Atopic Dermatitis, run by Click Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- CT-100-004-A and CT-100-004-B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- CT-100-004-A, CT-100-004-B
- Keywords
- Itching, DiNaMo
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-100-004-ADevice
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-BDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CT-100-004-A Psoriasis | Experimental | Not described Receives: Device: CT-100-004-A |
| CT-100-004-B Psoriasis | Sham comparator | Not described Receives: Device: CT-100-004-B |
| CT-100-004-A Atopic Dermatitis | Experimental | Not described Receives: Device: CT-100-004-A |
| CT-100-004-B Atopic Dermatitis | Sham comparator | Not described Receives: Device: CT-100-004-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Pruritus Numerical Rating Scale
Change from baseline to Week 4 in the Peak Pruritus Numerical Rating Scale (PP-NRS)
Measured: Baseline to Week 4
Change in Dermatology Life Quality Index
Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI)
Measured: 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
Measured: Baseline to Week 4
Time in App
Engagement with the App as measured by daily time in the App
Measured: 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
Measured: 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
Measured: Baseline to Week 4
Secondary outcomes (4)
Frequency of Adverse Events
Frequency of adverse events (AEs)
Measured: Baseline to Week 5
Severity of Adverse Events
Severity of adverse events (AEs)
Measured: Baseline to Week 5
Frequency of Serious Adverse Events
Frequency of Serious Adverse Events (AEs)
Measured: Baseline to Week 5
Severity of Serious Adverse Events
Severity of Serious Adverse Events (AEs)
Measured: Baseline to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start4 Dec 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275659
- Sponsor's protocol ID
- CT-100-D-003
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
- ClinicalTrials.gov ID
- NCT06275659
- Acronym / sponsor ID
- CT-100-D-003
- Conditions
- Psoriasis, Atopic Dermatitis
- Keywords
- Itching, DiNaMo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-100-004-ADigital 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. | Device | CT-100-004-A Atopic Dermatitis, CT-100-004-A Psoriasis |
| CT-100-004-BThe 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. | Device | CT-100-004-B Atopic Dermatitis, CT-100-004-B Psoriasis |
Primary outcome
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)
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)
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
Time in App
Time frame: Baseline to Week 4
Engagement with the App as measured by daily time in the App
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
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
4 secondary outcomes
Frequency of Adverse Events
Time frame: Baseline to Week 5
Severity of Adverse Events
Time frame: Baseline to Week 5
Frequency of Serious Adverse Events
Time frame: Baseline to Week 5
Severity of Serious Adverse Events
Time frame: Baseline to Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Lakhan study director
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-100-004-A and CT-100-004-B in people with Psoriasis and Atopic Dermatitis, run by Click Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Pruritus Numerical Rating Scale (time frame: Baseline to Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.