Lichen PlanusNCT04892381
Assessment of PD-1 and PD-L1Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
An observational study of Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial summary
Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Skin Biopsy
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2021to 22 Apr 2022
- How long will I take part?
- 12 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 30 male and female Lichen Planus patients. * 30 male and female normal healthy Controls. Patients will be selected from Kasr Al-ainy, Dermatology Outpatient Clinic.
Who may be able to join
- Age group above 18 years old
- Patients of both genders
- Classic type of cutaneous LP.
Who cannot join
- Topical treatment for LP 2 weeks before enrollment in the study or systemic treatment for LP 4 weeks before enrollment in the study and 3 years for systemic retenoids.
- Actinic LP , LP pigmentosus and Mucosal only LP
- Drug induced lichenoid eruption
- Conditions precluding taking skin biopsy : bleeding tendency , lidocaine allergy
- PD-1 associated-diseases e.g.: SLE, Cancers including melanoma and non-melanoma skin cancers, and Bullous Pemphigoid
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo
Rana A Mosaad, Msc, 201096344429, ranaahmedmosaad@gmail.com
Aya M Fahim, MD, 201141443447, ayafahim2011@yahoo.com
About this study
Official title: Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
Read the detailed description
This prospective Case Control study will be conducted at Kasr Al-Aini Dermatology Outpatient Clinics and will include 30 LP patients and 30 normal healthy controls which will be recruited and assessed for eligibility for inclusion according to the above criteria.
All participants (patients \& controls) will be subjected to the following:
- Written informed consent.
- Detailed history including onset, course, duration of the disease and history of drug intake within 1 month before the eruption.
- Clinical assessment of the Severity by using LP Severity Index (LPSI) (Kaur et al., 2020).
- Skin biopsy will be taken under local anesthesia :
- From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study.
- From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study:
- The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area
- The level of PD1 and PD-L1 will be detected using ELISA technique.
- The lesional biopsy will be assessed by routine hematoxylin and eosin (H\&E) to confirm the diagnosis of LP
- Patients' serial numbers only will be used on data collection sheets and ELISA specimens' labels. Data will be entered on a computer with access limited to the researchers in order to ensure confidentiality of patients' information and lab results.
- Conditions
- Lichen Planus
- Being tested
- Skin Biopsy
- Keywords
- LP, PD-1, PD-L1
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin BiopsyDiagnostic test
- Skin biopsy will be taken under local anesthesia :
- From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study.
- From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study:
- The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area
- The level of PD1 and PD-L1 will be detected using ELISA technique.
- The lesional biopsy will be assessed by routine hematoxylin and eosin (H\&E) to confirm the diagnosis of LP
| Study group | Role | What they receive |
|---|---|---|
| Lichen Planus group | Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA in lesional and non lesional skin Receives: Diagnostic Test: Skin Biopsy | |
| Control group | Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA Receives: Diagnostic Test: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the level of PD-1 and PD-L1 in the lesional and in non lesional skin in LP patients compared to normal controls
Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start18 Jun 2021 (estimated)
- Primary completion18 Apr 2022 (estimated)
- Study completion22 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Fahim, Cairo University
- Investigators
- Rana A Misaad, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892381
- Sponsor's protocol ID
- 13111993
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elmasry MF, Mosaad RA, Azzam OA, Rashed LA, Fahim A. Assessment of PD-1 and PD-L1 tissue expression levels in lichen planus patients: a case-control study. Arch Dermatol Res. 2024 Mar 2;316(3):97. doi: 10.1007/s00403-024-02838-z.
PubMed 38430309
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04892381
- Acronym / sponsor ID
- 13111993
- Conditions
- Lichen Planus
- Keywords
- LP, PD-1, PD-L1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jun 2021 (estimated)
- Primary completion
- 18 Apr 2022 (estimated)
- Study completion
- 22 Apr 2022 (estimated)
- First posted
- 19 May 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.
Assessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients: A Case-Control Study
Detailed description
This prospective Case Control study will be conducted at Kasr Al-Aini Dermatology Outpatient Clinics and will include 30 LP patients and 30 normal healthy controls which will be recruited and assessed for eligibility for inclusion according to the above criteria.
All participants (patients \& controls) will be subjected to the following:
- Written informed consent.
- Detailed history including onset, course, duration of the disease and history of drug intake within 1 month before the eruption.
- Clinical assessment of the Severity by using LP Severity Index (LPSI) (Kaur et al., 2020).
- Skin biopsy will be taken under local anesthesia :
- From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study.
- From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study:
- The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area
- The level of PD1 and PD-L1 will be detected using ELISA technique.
- The lesional biopsy will be assessed by routine hematoxylin and eosin (H\&E) to confirm the diagnosis of LP
- Patients' serial numbers only will be used on data collection sheets and ELISA specimens' labels. Data will be entered on a computer with access limited to the researchers in order to ensure confidentiality of patients' information and lab results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichen Planus group | – | Diagnostic Test: Skin BiopsyAssessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA in lesional and non lesional skin |
| Control group | – | Diagnostic Test: Skin BiopsyAssessment of Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels using ELISA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 30 male and female Lichen Planus patients. * 30 male and female normal healthy Controls. Patients will be selected from Kasr Al-ainy, Dermatology Outpatient Clinic.
Key inclusion criteria (3 listed)
- Age group above 18 years old
- Patients of both genders
- Classic type of cutaneous LP.
Key exclusion criteria (5 listed)
- Topical treatment for LP 2 weeks before enrollment in the study or systemic treatment for LP 4 weeks before enrollment in the study and 3 years for systemic retenoids.
- Actinic LP , LP pigmentosus and Mucosal only LP
- Drug induced lichenoid eruption
- Conditions precluding taking skin biopsy : bleeding tendency , lidocaine allergy
- PD-1 associated-diseases e.g.: SLE, Cancers including melanoma and non-melanoma skin cancers, and Bullous Pemphigoid
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 |
|---|---|---|
| Skin Biopsy* Skin biopsy will be taken under local anesthesia : * From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study. * From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study: i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area * The level of PD1 and PD-L1 will be detected using ELISA technique. * The lesional biopsy will be assessed by routine hematoxylin and eosin (H\&E) to confirm the diagnosis of LP | Diagnostic test | Control group, Lichen Planus group |
Primary outcome
Measurement of the level of PD-1 and PD-L1 in the lesional and in non lesional skin in LP patients compared to normal controls
Time frame: 12 months
Programmed Cell Death Protein 1 (PD-1) and Programmed Cell Death Ligand 1 (PD-L1) Tissue Expression Levels in Lichen Planus Patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 38430309Elmasry MF, Mosaad RA, Azzam OA, Rashed LA, Fahim A. Assessment of PD-1 and PD-L1 tissue expression levels in lichen planus patients: a case-control study. Arch Dermatol Res. 2024 Mar 2;316(3):97. doi: 10.1007/s00403-024-02838-z.
- 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.
Rana A Misaad principal investigator
Cairo 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 Lichen Planus, run by Cairo University 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana A Mosaad, Msc (201096344429, ranaahmedmosaad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the level of PD-1 and PD-L1 in the lesional and in non lesional skin in LP patients compared to normal controls (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892381, which also lists 1 linked publication.
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 19 May 2021.