PsoriasisNCT04560647
Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions
An observational study of Psoriasis, run by Wright State University at 1 site in United States.
Trial summary
The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Psoriasis
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 14 Apr 2023
- Phase
- Observational
- 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 to 50 years
- All sexes
- Adult
Study population: Plaque psoriasis patients and control patients from the Dayton, OH area.
Who may be able to join
- Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis.
- Must be able to give informed consent
- All skin types on Fitzpatrick Scale (Type I-VI)
- Able to provide medical history and list of medications for psoriasis and control subjects
Who cannot join
- Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- Tanning bed use within last 2 months
- Photodynamic Therapy or UVB treatments in past 2 months
- Female Subjects: pregnant or nursing
- History of abnormal scarring (i.e., keloids)
- Family history of psoriasis in first-degree relatives for control subjects
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.
- Conditions
- Psoriasis
- Being tested
- No intervention - Psoriasis Subject, No intervention - Control Subject
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - Psoriasis SubjectOther
Not currently treated plaque psoriasis patients
No intervention - Control SubjectOther
Control subjects without plaque psoriasis and no family history of psoriasis
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Subjects diagnosed with psoriasis. Receives: Other: No intervention - Psoriasis Subject | |
| Control | Subjects who do not have psoriasis. Receives: Other: No intervention - Control Subject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal P63 signaling levels
Determining if untreated psoriasis skin has abnormal p63 signaling
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start3 Dec 2020
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560647
- Sponsor's protocol ID
- 06956
- Status last verified
- Apr 2023
- First submitted
- 17 Sep 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions
- ClinicalTrials.gov ID
- NCT04560647
- Acronym / sponsor ID
- 06956
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 23 Sep 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.
The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Other: No intervention - Psoriasis SubjectSubjects diagnosed with psoriasis. |
| Control | – | Other: No intervention - Control SubjectSubjects who do not have psoriasis. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Plaque psoriasis patients and control patients from the Dayton, OH area.
Key inclusion criteria (4 listed)
- Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis.
- Must be able to give informed consent
- All skin types on Fitzpatrick Scale (Type I-VI)
- Able to provide medical history and list of medications for psoriasis and control subjects
Key exclusion criteria (6 listed)
- Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
- Tanning bed use within last 2 months
- Photodynamic Therapy or UVB treatments in past 2 months
- Female Subjects: pregnant or nursing
- History of abnormal scarring (i.e., keloids)
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 |
|---|---|---|
| No intervention - Psoriasis SubjectNot currently treated plaque psoriasis patients | Other | Psoriasis |
| No intervention - Control SubjectControl subjects without plaque psoriasis and no family history of psoriasis | Other | Control |
Primary outcome
Abnormal P63 signaling levels
Time frame: Day 0
Determining if untreated psoriasis skin has abnormal p63 signaling
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 21 Apr 2023.
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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.
Jeffrey B Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Wright State University 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 4 inclusion and 6 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 21 Apr 2023. 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. 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?
Abnormal P63 signaling levels (time frame: Day 0). 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 21 Apr 2023.