Lichen PlanusNCT02532166
Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus
A study testing Esophageal lichen planus in people with Lichen Planus, run by Ruhr University of Bochum at 2 sites in Germany.
Trial summary
The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Esophageal lichen planus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2012to Dec 2016
- Phase
- Interventional
- 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
- Age ≥ 18 years
- Known lichen planus of the oral mucosa
Who cannot join
- Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class > III
- Antisecretory and nonsteroidal anti-inflammatory medication within the last month
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Medicine
Bochum, 44892
Pohl Michael, MD, 0049 234 299 ext. 0, michael.pohl@rub.de
Michael Steckstor, MD, 0049 234 299 ext. 0, miachel.steckstor@rub.de
- Recruiting
Klinikum Agness Karll Laatzen
Laatzen, 30880
Andrea Riphaus, PD MD, 0049 511 8208 ext. 2400, ariphaus@web.de
Pohl Michale, MD, 0049 511 299 ext. 0, michael.pohl@rub.de
About this study
Official title: Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus. Diagnostic Value of White Light Endoscopy, Narrow Band Imaging and Chromoendoscopy for Detection of Esophageal Manifestation in Patients With Oral Lichen.
The lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus.
The value of moreover increasingly established endoscopic imaging procedures are investigated as well as data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation.
Read the detailed description
The lichen planus is a mucocutaneous disease of unknown etiology that manifests itself with an incidence of 1-2% in 30-70% of cases either at the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma. In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus. In addition, four cases have been reported with esophageal squamous cell carcinoma in patients with esophageal lichen planus.
The value of moreover increasingly established use of narrow-band imaging (a process for improving the detection of early cancers in the gastrointestinal tract by creating a maximum contrast between outright and altered mucosa, which could have already shown an improved detection rate of early lesions of the esophagus as well as squamous cell carcinoma), or the chromoendoscopy has means for example Lugol solution in correlation to the histopathologic findings in lichen planus), has not been investigated to date.
Also, data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation are currently not available.
- Conditions
- Lichen Planus
- Being tested
- Esophageal lichen planus
- Keywords
- narrow band imaging, Chromoendoscopy, Lugol
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal lichen planusOther
White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal lichen planus | Other | White light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen. Receives: Other: Esophageal lichen planus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.
Measured: 3-5 years
Secondary outcomes (1)
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.
Measured: 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (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.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Riphaus, Ruhr University of Bochum
- Investigators
- Andrea Riphaus, PD Dr, Principal investigator, Department of Medicine, KRH Laatzen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532166
- Sponsor's protocol ID
- 2011-4072
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Quispel R, van Boxel OS, Schipper ME, Sigurdsson V, Canninga-van Dijk MR, Kerckhoffs A, Smout AJ, Samsom M, Schwartz MP. High prevalence of esophageal involvement in lichen planus: a study using magnification chromoendoscopy. Endoscopy. 2009 Mar;41(3):187-93. doi: 10.1055/s-0028-1119590. Epub 2009 Mar 11.
PubMed 19280529
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Esophageal Lichen Planus in Patients With Known Oral Lichen Planus. Diagnostic Value of White Light Endoscopy, Narrow Band Imaging and Chromoendoscopy for Detection of Esophageal Manifestation in Patients With Oral Lichen.
- ClinicalTrials.gov ID
- NCT02532166
- Acronym / sponsor ID
- 2011-4072
- Conditions
- Lichen Planus
- Keywords
- narrow band imaging, Chromoendoscopy, Lugol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Aug 2015 (estimated)
- 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 lichen planus is a mucocutaneous disease of unknown etiology with an incidence of 1-2%, that affects in 30-70% of cases either the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma.In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus.
The value of moreover increasingly established endoscopic imaging procedures are investigated as well as data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation.
Detailed description
The lichen planus is a mucocutaneous disease of unknown etiology that manifests itself with an incidence of 1-2% in 30-70% of cases either at the mucosa of the mouth, or partly in combination with infection of the skin, the oral with his known premalignant potential in up to 2-3% predisposed to the development of an oral squamous cell carcinoma. In rare cases, there is also an manifestation of the lining of the esophagus, which can then be associated with symptomatic strictures of the esophagus. In addition, four cases have been reported with esophageal squamous cell carcinoma in patients with esophageal lichen planus.
The value of moreover increasingly established use of narrow-band imaging (a process for improving the detection of early cancers in the gastrointestinal tract by creating a maximum contrast between outright and altered mucosa, which could have already shown an improved detection rate of early lesions of the esophagus as well as squamous cell carcinoma), or the chromoendoscopy has means for example Lugol solution in correlation to the histopathologic findings in lichen planus), has not been investigated to date.
Also, data of the natural long-term outcome in esophageal lichen planus infestation especially in view of malignant transformation are currently not available.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal lichen planus | Other | Other: Esophageal lichen planusWhite light endoscopy compared to narrow band imaging and chromoendoscopy with Lugol for detection of esophageal lichen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Known lichen planus of the oral mucosa
Key exclusion criteria (2 listed)
- Severe cardiopulmonary disease - ASA (American Society of Anaesthesiology) class > III
- Antisecretory and nonsteroidal anti-inflammatory medication within the last month
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 |
|---|---|---|
| Esophageal lichen planusWhite light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen. | Other | Esophageal lichen planus |
Primary outcome
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus.
Time frame: 3-5 years
1 secondary outcome
Natural long-term incidence of esophageal lichen planus in patients with known oral lichen.
Time frame: 3-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Background: PubMed 19280529Quispel R, van Boxel OS, Schipper ME, Sigurdsson V, Canninga-van Dijk MR, Kerckhoffs A, Smout AJ, Samsom M, Schwartz MP. High prevalence of esophageal involvement in lichen planus: a study using magnification chromoendoscopy. Endoscopy. 2009 Mar;41(3):187-93. doi: 10.1055/s-0028-1119590. Epub 2009 Mar 11.
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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.
Andrea Riphaus, PD Dr principal investigator
Department of Medicine, KRH Laatzen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal lichen planus in people with Lichen Planus, run by Ruhr University of Bochum at 2 sites in Germany.
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 2 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 25 Aug 2015. 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 Germany. 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 Andrea Riphaus, PD MD (0049 511 8208 ext. 2400, ariphaus@web.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of additional endoscopic enhancing imaging methods for detection of esophageal lichen planus. (time frame: 3-5 years). 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 NCT02532166, 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 25 Aug 2015.