Lichen Planus, OralNCT06652477
Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Oral Lichen Planus and Correlation with Disease Severity
An observational study of Lichen Planus, Oral, run by Ain Shams University.
Trial summary
1. evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective). 2. correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- ELISA
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2024to 5 Dec 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is designed to be a case-control study with a convenience sample size of (20) Participants, will be recruited from the Out-patient Clinic of Oral Medicine, Periodontology and Oral Diagnosis Department, Faculty of Dentistry Ain-Shams University or referred to it. The participants who will meet the eligibility criteria will be enrolled into one of the following groups • Group A: (10) participants suffering from oral lichen planus (atrophic bullous erosive pattern). • Group B: (10) healthy control participants. Tissue samples from the control group will be obtained from excess tissue from periodontal surgeries, mainly crown lengthening surgeries and implant placement surgeries (avoiding any periodontally affected teeth)
Who may be able to join
- 1. Males or females suffering from A/BE OLP. 2. Proven diagnosis of oral lichen planus based on criteria of WHO (World Health Organization) which is a clinical criteria, clinically proven painful A/BE form of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae).
- Histopathologically, proven Bullous/erosive or reticular forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band-like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region.
Who cannot join
- 1. History of drug-induced lichenoid lesions. 2. Presence of systemic conditions such as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
- 3. Pregnancy or breastfeeding. 4. History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
- 5. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- 6. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- 7. Patient refuses to participate in the study. 8. Vulnerable groups (handicapped, orphans, and prisoners).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Atrophic/Bullous Erosive Oral Lichen Planus and Correlation with Disease Severity
- evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective).
- correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective).
Read the detailed description
Oral lichen planus (OLP), a chronic disease and one of the most common dermatoses of the oral mucosa, is characterized by white streaks in a lacelike pattern on the tongue and/or buccal mucosa. The disease is also accompanied by chronic inflammation, the degree of which, correlates with the intensity of the symptoms.
OLP occurs more frequently than the cutaneous form and tends to be more persistent and more resistant to treatment. It affects one to two percent of the general adult population, with a higher prevalence in the female gender, and occurs predominantly in adults over 40, although younger adults and children may be affected .
The most common site of oral involvement is the buccal mucosa followed by the tongue and gingiva, but any site of the oral mucosa can be affected. Clinically, OLP is classified as reticular, atrophic, erosive, plaque-type, and bullous. The reticular pattern is the most common form. It is generally asymptomatic and requires no treatment. In contrast, atrophic-erosive forms usually manifest as erythematous, ulcerative lesions associated with symptoms, fluctuating from mild burning sensation to severe pain, interfering with eating and speaking .
Furthermore, OLP is considered a potentially malignant disorder with a transformation rate of about 1.09%, with greater risk among those with atrophic-erosive forms.
The etiology and pathogenesis of OLP are not completely understood. Several factors have been implicated in the etiology and several hypotheses have been proposed for its pathogenesis.
It is believed that OLP represents an abnormal immune reaction in which keratinocytes are recognized as an antigen, secondary to changes in the antigenicity of the cell surface. This elicits an immune response characterized by invasion of inflammatory cells into the subepithelial layer of connective tissue with degeneration of the epithelium of the basement membrane However, the antigen or antigens triggering factors have not been identified.
Many controversies exist about the pathogenesis of OLP. A large body of evidence supports the role of immune dysregulation in the pathogenesis. The various mechanisms hypothesized to be involved in immunopathogenesis include humoral immunity, antigen-specific cell-mediated immune response, non-specific mechanisms, and autoimmune response.
Humoral immunity has been reported to play a role in the pathogenesis of OLP in addition to the presence of immunoglobulins, fibrinogen, and C3 complement in the basement membrane at the lesional and perilesional tissue Furthermore, concentrations of salivary IgG and IgA subclasses may be changed .
Antigen-specific mechanisms in OLP include antigen presentation by basal keratinocytes, followed by antigen-specific keratinocyte killing by CD8+ cytotoxic T-cells.
Non-specific mechanisms include mast cell degranulation and matrix metalloproteinase activation in OLP lesions. These mechanisms may combine to cause T-cell accumulation in the superficial lamina propria, basement membrane disruption, intra-epithelial T-cell migration, and keratinocyte apoptosis .
The possibility of the presence of circulating antibodies was previously indicated against desmoglein 3 (Dsg3) in patients with OLP.
Desmogleins (Dsgs) are the main components of cellular coherence in the epidermis and mucosal surfaces. They are consisting of (Dsg1), (Dsg2), (Dsg3), and (Dsg4). Dsg3 antigen is expressed in the basement membrane zone of the epidermis keeping the cells from detachment.
Dsgs are the victims of autoantibody reaction in some autoimmune bullous diseases such as pemphigus vulgaris and bullous pemphigoid causing disruption of desmosomes and consequent acantholysis.
In 2006, Lukac et al. demonstrated significantly higher concentrations of circulating autoantibodies against Dsg3 among erosive OLP patients and in patients with reticular OLP .
In a recent study including 100 OLP patients, 65% of the patients showed the presence of at least one type of autoantibodies in their serum. Dsg3 autoantibody was positive in 16% of the patients .
Furthermore, Saad et al, in 2018, showed increased levels of Dsg3 autoantibodies in the serum of patients with erosive OLP at baseline and after the use of topical Tacrolimus 0.1%. The results revealed a statistically significant decrease in the level of Dsg3 autoantibodies during the follow-up period.
In 2022, El-Rifaie et al detected that the level of Dsg3 autoantibodies in the serum of OLP patients was significantly higher as compared to normal control persons.
However, it is difficult to infer whether the anti-Dsg3 autoantibodies in lichen planus are of primary pathogenic significance or are a result of epitope spreading which is known to occur in autoimmune diseases. These autoantibodies may be increased as an etiologic agent in OLP or due to inflammatory damage to basal keratinocytes. This damage releases the Dsg3 proteins which act as auto-antigens for autoantibodies formation in the circulatory blood .
All the studies were concerned with detecting Dsg3 autoantibodies level in the serum of OLP patients. Unfortunately, such results do not prove the source of Dsg3 autoantibodies to be the OLP lesions. Thus, the present study will be carried out to detect the level of Dsg3 autoantibodies in tissues affected by atrophic/bullous erosive OLP trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.
- Conditions
- Lichen Planus, Oral
- Being tested
- ELISA
- 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.
ELISADiagnostic test
ElISA kit to detect autoantibodies against desmoglein 3 in tissues of oral lichen planus lesions
| Study group | Role | What they receive |
|---|---|---|
| groupe A | patients with atrophic boullos erosive oral lichen planus Receives: Diagnostic Test: ELISA | |
| groupe B | healthy patients Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus
valuate the level of Dsg3 autoantibodies by ELISA kit trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.
Measured: baseline
Secondary outcomes (1)
correlate the severity of the disease with the level of tissue Dsg3 autoantibodies
we will evaluate the disease severity by Clinical scoring system and correlate it with the level of autoantibodies
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start5 Nov 2024 (estimated)
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa abdelwadood mohamed ibrahim essa, Ain Shams University
- Investigators
- Ahmed Amr, Principal investigator, ain shamsh universityyasmeen foaad, Study director, ain shamsh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652477
- Sponsor's protocol ID
- Dsg3 in oral lichen planus
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roopashree MR, Gondhalekar RV, Shashikanth MC, George J, Thippeswamy SH, Shukla A. Pathogenesis of oral lichen planus--a review. J Oral Pathol Med. 2010 Nov;39(10):729-34. doi: 10.1111/j.1600-0714.2010.00946.x. Epub 2010 Oct 4.
PubMed 20923445Vahide L, Zahra H, Forugh G, Nazi S. Autoantibodies to desmogleins 1 and 3 in patients with lichen planus. Arch Dermatol Res. 2017 Sep;309(7):579-583. doi: 10.1007/s00403-017-1756-x. Epub 2017 Jul 3.
PubMed 28674915Lukac J, Brozovic S, Vucicevic-Boras V, Mravak-Stipetic M, Malenica B, Kusic Z. Serum autoantibodies to desmogleins 1 and 3 in patients with oral lichen planus. Croat Med J. 2006 Feb;47(1):53-8.
PubMed 16489697Abdelwadood D, Fouad YA, El-Khazragy N, Amr AEH. Desmoglein-3 autoantibodies in tissues of oral lichen planus patients and its correlation with disease severity: case-control study. BMC Oral Health. 2025 Jun 6;25(1):930. doi: 10.1186/s12903-025-06303-9.
PubMed 40481453
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Desmoglein-3 Autoantibodies in the Tissues of Atrophic/Bullous Erosive Oral Lichen Planus and Correlation with Disease Severity
- ClinicalTrials.gov ID
- NCT06652477
- Acronym / sponsor ID
- Dsg3 in oral lichen planus
- Conditions
- Lichen Planus, Oral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Nov 2024 (estimated)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 22 Oct 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.
- evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive (A/BE) OLP (Primary Objective).
- correlate the severity of the disease with the level of tissue Dsg3 autoantibodies (Secondary Objective).
Detailed description
Oral lichen planus (OLP), a chronic disease and one of the most common dermatoses of the oral mucosa, is characterized by white streaks in a lacelike pattern on the tongue and/or buccal mucosa. The disease is also accompanied by chronic inflammation, the degree of which, correlates with the intensity of the symptoms.
OLP occurs more frequently than the cutaneous form and tends to be more persistent and more resistant to treatment. It affects one to two percent of the general adult population, with a higher prevalence in the female gender, and occurs predominantly in adults over 40, although younger adults and children may be affected .
The most common site of oral involvement is the buccal mucosa followed by the tongue and gingiva, but any site of the oral mucosa can be affected. Clinically, OLP is classified as reticular, atrophic, erosive, plaque-type, and bullous. The reticular pattern is the most common form. It is generally asymptomatic and requires no treatment. In contrast, atrophic-erosive forms usually manifest as erythematous, ulcerative lesions associated with symptoms, fluctuating from mild burning sensation to severe pain, interfering with eating and speaking .
Furthermore, OLP is considered a potentially malignant disorder with a transformation rate of about 1.09%, with greater risk among those with atrophic-erosive forms.
The etiology and pathogenesis of OLP are not completely understood. Several factors have been implicated in the etiology and several hypotheses have been proposed for its pathogenesis.
It is believed that OLP represents an abnormal immune reaction in which keratinocytes are recognized as an antigen, secondary to changes in the antigenicity of the cell surface. This elicits an immune response characterized by invasion of inflammatory cells into the subepithelial layer of connective tissue with degeneration of the epithelium of the basement membrane However, the antigen or antigens triggering factors have not been identified.
Many controversies exist about the pathogenesis of OLP. A large body of evidence supports the role of immune dysregulation in the pathogenesis. The various mechanisms hypothesized to be involved in immunopathogenesis include humoral immunity, antigen-specific cell-mediated immune response, non-specific mechanisms, and autoimmune response.
Humoral immunity has been reported to play a role in the pathogenesis of OLP in addition to the presence of immunoglobulins, fibrinogen, and C3 complement in the basement membrane at the lesional and perilesional tissue Furthermore, concentrations of salivary IgG and IgA subclasses may be changed .
Antigen-specific mechanisms in OLP include antigen presentation by basal keratinocytes, followed by antigen-specific keratinocyte killing by CD8+ cytotoxic T-cells.
Non-specific mechanisms include mast cell degranulation and matrix metalloproteinase activation in OLP lesions. These mechanisms may combine to cause T-cell accumulation in the superficial lamina propria, basement membrane disruption, intra-epithelial T-cell migration, and keratinocyte apoptosis .
The possibility of the presence of circulating antibodies was previously indicated against desmoglein 3 (Dsg3) in patients with OLP.
Desmogleins (Dsgs) are the main components of cellular coherence in the epidermis and mucosal surfaces. They are consisting of (Dsg1), (Dsg2), (Dsg3), and (Dsg4). Dsg3 antigen is expressed in the basement membrane zone of the epidermis keeping the cells from detachment.
Dsgs are the victims of autoantibody reaction in some autoimmune bullous diseases such as pemphigus vulgaris and bullous pemphigoid causing disruption of desmosomes and consequent acantholysis.
In 2006, Lukac et al. demonstrated significantly higher concentrations of circulating autoantibodies against Dsg3 among erosive OLP patients and in patients with reticular OLP .
In a recent study including 100 OLP patients, 65% of the patients showed the presence of at least one type of autoantibodies in their serum. Dsg3 autoantibody was positive in 16% of the patients .
Furthermore, Saad et al, in 2018, showed increased levels of Dsg3 autoantibodies in the serum of patients with erosive OLP at baseline and after the use of topical Tacrolimus 0.1%. The results revealed a statistically significant decrease in the level of Dsg3 autoantibodies during the follow-up period.
In 2022, El-Rifaie et al detected that the level of Dsg3 autoantibodies in the serum of OLP patients was significantly higher as compared to normal control persons.
However, it is difficult to infer whether the anti-Dsg3 autoantibodies in lichen planus are of primary pathogenic significance or are a result of epitope spreading which is known to occur in autoimmune diseases. These autoantibodies may be increased as an etiologic agent in OLP or due to inflammatory damage to basal keratinocytes. This damage releases the Dsg3 proteins which act as auto-antigens for autoantibodies formation in the circulatory blood .
All the studies were concerned with detecting Dsg3 autoantibodies level in the serum of OLP patients. Unfortunately, such results do not prove the source of Dsg3 autoantibodies to be the OLP lesions. Thus, the present study will be carried out to detect the level of Dsg3 autoantibodies in tissues affected by atrophic/bullous erosive OLP trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| groupe A | – | Diagnostic Test: ELISApatients with atrophic boullos erosive oral lichen planus |
| groupe B | – | Diagnostic Test: ELISAhealthy patients |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is designed to be a case-control study with a convenience sample size of (20) Participants, will be recruited from the Out-patient Clinic of Oral Medicine, Periodontology and Oral Diagnosis Department, Faculty of Dentistry Ain-Shams University or referred to it. The participants who will meet the eligibility criteria will be enrolled into one of the following groups • Group A: (10) participants suffering from oral lichen planus (atrophic bullous erosive pattern). • Group B: (10) healthy control participants. Tissue samples from the control group will be obtained from excess tissue from periodontal surgeries, mainly crown lengthening surgeries and implant placement surgeries (avoiding any periodontally affected teeth)
Key inclusion criteria (2 listed)
- 1. Males or females suffering from A/BE OLP. 2. Proven diagnosis of oral lichen planus based on criteria of WHO (World Health Organization) which is a clinical criteria, clinically proven painful A/BE form of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae).
- Histopathologically, proven Bullous/erosive or reticular forms of OLP confirmed by the presence of accepted histopathological criteria for lichen planus; basal cell liquefaction, band-like lymphocytic infiltrate at the epithelial-stromal junction with degeneration of basal cell region.
Key exclusion criteria (5 listed)
- 1. History of drug-induced lichenoid lesions. 2. Presence of systemic conditions such as serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases.
- 3. Pregnancy or breastfeeding. 4. History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications prior to starting the study.
- 5. Loss of pliability or flexibility in the tissues involved by the oral lesions of lichen planus.
- 6. Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
- 7. Patient refuses to participate in the study. 8. Vulnerable groups (handicapped, orphans, and prisoners).
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 |
|---|---|---|
| ELISAElISA kit to detect autoantibodies against desmoglein 3 in tissues of oral lichen planus lesions | Diagnostic test | groupe A, groupe B |
Primary outcome
evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus
Time frame: baseline
valuate the level of Dsg3 autoantibodies by ELISA kit trying to elucidate the actual role of Dsg3 autoantibodies in the etiopathogenesis of OLP.
1 secondary outcome
correlate the severity of the disease with the level of tissue Dsg3 autoantibodies
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Background: PubMed 20923445Roopashree MR, Gondhalekar RV, Shashikanth MC, George J, Thippeswamy SH, Shukla A. Pathogenesis of oral lichen planus--a review. J Oral Pathol Med. 2010 Nov;39(10):729-34. doi: 10.1111/j.1600-0714.2010.00946.x. Epub 2010 Oct 4.
- Background: PubMed 28674915Vahide L, Zahra H, Forugh G, Nazi S. Autoantibodies to desmogleins 1 and 3 in patients with lichen planus. Arch Dermatol Res. 2017 Sep;309(7):579-583. doi: 10.1007/s00403-017-1756-x. Epub 2017 Jul 3.
- Background: PubMed 16489697Lukac J, Brozovic S, Vucicevic-Boras V, Mravak-Stipetic M, Malenica B, Kusic Z. Serum autoantibodies to desmogleins 1 and 3 in patients with oral lichen planus. Croat Med J. 2006 Feb;47(1):53-8.
- Derived from this study: PubMed 40481453Abdelwadood D, Fouad YA, El-Khazragy N, Amr AEH. Desmoglein-3 autoantibodies in tissues of oral lichen planus patients and its correlation with disease severity: case-control study. BMC Oral Health. 2025 Jun 6;25(1):930. doi: 10.1186/s12903-025-06303-9.
- 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.
Ahmed Amr principal investigator
ain shamsh university
yasmeen foaad study director
ain shamsh university
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Planus, Oral, run by Ain Shams University.
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 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 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Doaa Abd Elwadood Mohamed, master's degree student (01118066148, Dr.doaa55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the level of Dsg3 autoantibodies in tissue biopsy of Atrophic/Bullous Erosive oral lichen planus (time frame: baseline). 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 NCT06652477, which also lists 4 linked publications.
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 22 Oct 2024.