Scalp PsoriasisPhase 2NCT04243486
A Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis
A Phase 2 study testing UHE-105 in people with Scalp Psoriasis, run by Therapeutics, Inc. at 2 sites in United States.
Trial summary
This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- UHE-105
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jan 2020to 15 Jun 2020
- Phase
- Phase 2
- 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
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile or use an effective method of birth control. , Women of childbearing potential must have a negative urine pregnancy test at Visit 1/Baseline.
- Subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of scalp psoriasis or exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating scalp psoriasis.
- Subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis.
- Subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome), or which exposes the subject to an unacceptable risk by study participation.
- Subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study.
- Subject has a history of psoriasis unresponsive to topical treatments.
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- Subject has any hair on their scalp of a length that extends beyond the subject's chin.
- Subject has any open sores, lesions, cuts, or infections, etc. on the scalp or has had a scalp surgical procedure within the past 30 days.
- Subject is currently enrolled in an investigational drug or device study.
- Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
02
High Point, North Carolina, 27262
01
San Diego, California, 92123
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis
This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.
- Conditions
- Scalp Psoriasis
- Being tested
- UHE-105, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHE-105Drug
Topical shampoo containing active drug
VehicleDrug
Topical shampoo containing no active drug
| Study group | Role | What they receive |
|---|---|---|
| UHE-105 Shampoo | Experimental | UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks Receives: Drug: UHE-105 |
| Vehicle Shampoo | Placebo comparator | Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment (IGA) Treatment Success
The percentage of subjects classified as IGA treatment success
Measured: Day 15
Investigator's Global Assessment (IGA) Treatment Success
The percentage of subjects classified as IGA treatment success
Measured: Day 29
Secondary outcomes (3)
Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success
Percentage of subjects classified as treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation)
Measured: Days 8, 15, and 29
Change in Percentage of scalp affected by psoriasis
Change from baseline in the percentage of scalp affected by psoriasis
Measured: Days 8, 15, and 29
Percentage of subjects with pruritus severity score treatment success
Percentage of subjects classified as treatment success for change from baseline in pruritus severity score using an 11-point numeric rating scale (0-10)
Measured: Days 8, 15, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start2 Jan 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scalp 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Andrasfay, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243486
- Sponsor's protocol ID
- 188-0552-202
- Status last verified
- Jul 2020
- First submitted
- 20 Jan 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT04243486
- Acronym / sponsor ID
- 188-0552-202
- Conditions
- Scalp Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 28 Jan 2020 (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.
This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHE-105 Shampoo | Experimental | Drug: UHE-105UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks |
| Vehicle Shampoo | Placebo comparator | Drug: VehicleVehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile or use an effective method of birth control. , Women of childbearing potential must have a negative urine pregnancy test at Visit 1/Baseline.
- Subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Key exclusion criteria (10 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has spontaneously improving or rapidly deteriorating scalp psoriasis.
- Subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis.
- Subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome), or which exposes the subject to an unacceptable risk by study participation.
- Subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study.
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 |
|---|---|---|
| UHE-105Topical shampoo containing active drug | Drug | UHE-105 Shampoo |
| VehicleTopical shampoo containing no active drug | Drug | Vehicle Shampoo |
Primary outcome
Investigator's Global Assessment (IGA) Treatment Success
Time frame: Day 15
The percentage of subjects classified as IGA treatment success
Investigator's Global Assessment (IGA) Treatment Success
Time frame: Day 29
The percentage of subjects classified as IGA treatment success
3 secondary outcomes
Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success
Time frame: Days 8, 15, and 29
Change in Percentage of scalp affected by psoriasis
Time frame: Days 8, 15, and 29
Percentage of subjects with pruritus severity score treatment success
Time frame: Days 8, 15, and 29
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 9 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Scalp Psoriasis
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Plaque Psoriasis
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Immune Spatial Features of Guselkumab Cutaneous Response
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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.
Tony Andrasfay study director
Therapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UHE-105 in people with Scalp Psoriasis, run by Therapeutics, Inc. at 2 sites 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 6 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Investigator's Global Assessment (IGA) Treatment Success (time frame: Day 15). The study lists 2 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 9 Jul 2020.