Oral Lichen PlanusNCT04785703
Prolactin Hormone in Oral Lichen Planus
An observational study of Oral Lichen Planus, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jun 2020to 10 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Egyptian patients with OLP
Who may be able to join
- patients with oral lichen planus
- systemically healthy
Who cannot join
- oral lichenoid lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolactin Hormone in Oral Lichen Planus Tissue Samples
Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of this study is to investigate the expression of PRL receptors in tissue biopsies of OLP patients.
- Conditions
- Oral Lichen Planus
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| oral lichen planus group | patients with chronic bollus erosive lichen planus |
What is being measured
The primary outcome is the main question the study is designed to answer.
prolactin receptors expression in oral mucous membrane
immuno-histochemistry
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start19 Jun 2020
- Primary completion22 Aug 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Naglaa Elwakeel, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785703
- Sponsor's protocol ID
- REC18-048
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- 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 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolactin Hormone in Oral Lichen Planus Tissue Samples
- ClinicalTrials.gov ID
- NCT04785703
- Acronym / sponsor ID
- REC18-048
- Conditions
- Oral Lichen Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 22 Aug 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 8 Mar 2021 (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.
Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of this study is to investigate the expression of PRL receptors in tissue biopsies of OLP patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral lichen planus group | – | –patients with chronic bollus erosive lichen planus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Egyptian patients with OLP
Key inclusion criteria (2 listed)
- patients with oral lichen planus
- systemically healthy
Key exclusion criteria (1 listed)
- oral lichenoid lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prolactin receptors expression in oral mucous membrane
Time frame: 24 hours
immuno-histochemistry
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 8 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral Lichen Planus, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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 2 inclusion and 1 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 8 Mar 2021. 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 Egypt. 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?
prolactin receptors expression in oral mucous membrane (time frame: 24 hours). 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 8 Mar 2021.