Oral Lichen PlanusPhase 4NCT02443311
Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus
A Phase 4 study testing Pimecrolimus 1% cream and Betamethasone 17-valerate 0.1% cream in people with Oral Lichen Planus, run by Ain Shams University.
Trial summary
Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Pimecrolimus 1% cream and Betamethasone 17-valerate 0.1% cream
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Aug 2012
- Phase
- Phase 4
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinically and histologically confirmed painful Erosive or Atrophic OLP
- free from any systemic diseases using medical questionnaire guided by Cornell Medical Index
Who cannot join
- history of drug induced lichenoid lesions
- potential treatment of OLP for less than 2 weeks by topical and 4 weeks systemic therapy before study start
- pregnant or breast-feeding women,
- smoking and
- known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
- loss of paliability or flexibility in the tissues involved by the oral lesions or histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
About this study
Official title: A Comparative Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus
Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus may effectively treat OLP without the potential side effects that are associated with corticosteroids.
Read the detailed description
Lichen planus is a chronic, immunological, mucocutaneous disease, characterized by periods of remission and relapse1. Oral lichen planus (OLP) is one of the most common mucocutaneous diseases manifesting in the oral cavity, and the oral mucosa may be the only site of involvement 2, with variable incidence between 0.5% and 4% 3. Three major clinical forms of OLP (reticular, erosive/ ulcerative, and erythematous/atrophic) have been recognized, which could alternate and overlap in a dynamic state as disease progresses. Ulceration is the most severe form that it interferes with eating, speech, and swallowing. Erosive OLP lasts for years, resistance to treatment and spontaneous remissions are rare 4,5. Oral lichen planus is a T-cell-mediated chronic inflammatory oral mucosal disease. Both antigen-specific and non-specific mechanisms may be involved in the pathogenesis of OLP. Antigen-specific mechanisms include antigen presentation by basal keratinocytes to CD4+ helper T-cells that are stimulated to secrete the T helper -1 cytokines IL-2 and IFN-γ. Subsequently, CD8+ cytotoxic T-cells may be activated which then trigger basal keratinocyte apoptosis in OLP. While, non-specific mechanisms include mast cell degranulation and matrix metalloproteinase (MMP) activation in OLP lesions 6. The best known treatment of OLP remains high-potency topical corticosteroids7. However, corticosteroids are known to induce local atrophy, fragility, and telangiectasias, and to promote infections, including acute candidiasis. They also have theoretical risks of lowering local immunity, corticosteroids can exert their effects on the immune system by modulating transcription of genes in cells involved in immune response and other cell types; therefore this mode of action is not selective for the pathogenesis of lichen planus 8-10. A recent Cochrane review showed only little evidence for superiority of the assessed interventions over placebo for palliation of symptomatic OLP and recommended the need of randomized clinical trials on new therapies 11. Pimecrolimus a novel topical selective inflammatory cytokine release inhibitor; that binds to intra-cytoplsmic protein (macrophillin-12) subsequently inhibiting dephosphorylation of nuclear factor of activated T cells by calcineurin; this markedly reduces T-cell cytokine production. Given the T-cell-mediated pathogenesis of OLP, application of this calcineurin inhibitor seems to be a promising therapeutic option 12-14. Several case studies and open-label trials used topical pimecrolimus in treatment of OLP reported beneficial effects 12,15. Few prospective, randomized, vehicle-controlled studies have also been conducted and proved benefit of pimecrolimus over placebo 16,10,17. And one recent prospective study compared the effect of topical pimecrolimus with topical corticosteroid in treatment of OLP 18. The purpose of this study was to compare the effectiveness of topical pimecrolimus 1% with topical corticosteroid, in the treatment of oral erosive and atrophic lichen planus as a prospective, comparative clinical trial.
- Conditions
- Oral Lichen Planus
- Being tested
- Pimecrolimus 1% cream, Betamethasone 17-valerate 0.1% cream
- 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.
Pimecrolimus 1% creamDrug
Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.
Betamethasone 17-valerate 0.1% creamDrug
Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.Topical antifungal Miconazole 2% gel (Miconaz, oral Medical Union Pharmaceutical, Cairo, Egypt) was applied only in the fourth week of treatment period to avoid secondary candidiosis
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Pimecrolimus 1% cream (Elidel, Novartis Pharmaceuticals, East Hanover, NJ)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks Receives: Drug: Pimecrolimus 1% cream |
| Group II | Active comparator | Betamethasone 17-valerate 0.1% cream (Betnovate, GlaxoSmithKline, Cairo, Egypt)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks Receives: Drug: Betamethasone 17-valerate 0.1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical scoring (CS)
0 represented no lesion/normal mucosa; 1, mild white striae/no erythematous area; 2, white striae with atrophic area less than 1 cm²; 3, white striae with atrophic area more than 1 cm²; 4, white striae with erosive area less than 1 4 cm²; and 5, white striae with erosive area more than 1 cm²
Measured: 2 months/ once per week for one months then after 2 months
visual analog scale (VAS)
Patients also ranked the severity of pain and burning sensation on 100-mm visual analog scale
Measured: 2 months/ once per week for one months then after 2 months
Secondary outcomes (1)
CD4+,CD8+, CD133
Immunohistochemical analysis
Measured: baseline and after 1 month treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionAug 2012
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Ezzatt, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443311
- Sponsor's protocol ID
- FDASU-RECD 1214401
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT02443311
- Acronym / sponsor ID
- FDASU-RECD 1214401
- Conditions
- Oral Lichen Planus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 May 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.
Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus may effectively treat OLP without the potential side effects that are associated with corticosteroids.
Detailed description
Lichen planus is a chronic, immunological, mucocutaneous disease, characterized by periods of remission and relapse1. Oral lichen planus (OLP) is one of the most common mucocutaneous diseases manifesting in the oral cavity, and the oral mucosa may be the only site of involvement 2, with variable incidence between 0.5% and 4% 3. Three major clinical forms of OLP (reticular, erosive/ ulcerative, and erythematous/atrophic) have been recognized, which could alternate and overlap in a dynamic state as disease progresses. Ulceration is the most severe form that it interferes with eating, speech, and swallowing. Erosive OLP lasts for years, resistance to treatment and spontaneous remissions are rare 4,5. Oral lichen planus is a T-cell-mediated chronic inflammatory oral mucosal disease. Both antigen-specific and non-specific mechanisms may be involved in the pathogenesis of OLP. Antigen-specific mechanisms include antigen presentation by basal keratinocytes to CD4+ helper T-cells that are stimulated to secrete the T helper -1 cytokines IL-2 and IFN-γ. Subsequently, CD8+ cytotoxic T-cells may be activated which then trigger basal keratinocyte apoptosis in OLP. While, non-specific mechanisms include mast cell degranulation and matrix metalloproteinase (MMP) activation in OLP lesions 6. The best known treatment of OLP remains high-potency topical corticosteroids7. However, corticosteroids are known to induce local atrophy, fragility, and telangiectasias, and to promote infections, including acute candidiasis. They also have theoretical risks of lowering local immunity, corticosteroids can exert their effects on the immune system by modulating transcription of genes in cells involved in immune response and other cell types; therefore this mode of action is not selective for the pathogenesis of lichen planus 8-10. A recent Cochrane review showed only little evidence for superiority of the assessed interventions over placebo for palliation of symptomatic OLP and recommended the need of randomized clinical trials on new therapies 11. Pimecrolimus a novel topical selective inflammatory cytokine release inhibitor; that binds to intra-cytoplsmic protein (macrophillin-12) subsequently inhibiting dephosphorylation of nuclear factor of activated T cells by calcineurin; this markedly reduces T-cell cytokine production. Given the T-cell-mediated pathogenesis of OLP, application of this calcineurin inhibitor seems to be a promising therapeutic option 12-14. Several case studies and open-label trials used topical pimecrolimus in treatment of OLP reported beneficial effects 12,15. Few prospective, randomized, vehicle-controlled studies have also been conducted and proved benefit of pimecrolimus over placebo 16,10,17. And one recent prospective study compared the effect of topical pimecrolimus with topical corticosteroid in treatment of OLP 18. The purpose of this study was to compare the effectiveness of topical pimecrolimus 1% with topical corticosteroid, in the treatment of oral erosive and atrophic lichen planus as a prospective, comparative clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Pimecrolimus 1% creamPimecrolimus 1% cream (Elidel, Novartis Pharmaceuticals, East Hanover, NJ)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks |
| Group II | Active comparator | Drug: Betamethasone 17-valerate 0.1% creamBetamethasone 17-valerate 0.1% cream (Betnovate, GlaxoSmithKline, Cairo, Egypt)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinically and histologically confirmed painful Erosive or Atrophic OLP
- free from any systemic diseases using medical questionnaire guided by Cornell Medical Index
Key exclusion criteria (6 listed)
- history of drug induced lichenoid lesions
- potential treatment of OLP for less than 2 weeks by topical and 4 weeks systemic therapy before study start
- pregnant or breast-feeding women,
- smoking and
- known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
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 |
|---|---|---|
| Pimecrolimus 1% creamPatients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application. | Drug | Group I |
| Betamethasone 17-valerate 0.1% creamPatients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.Topical antifungal Miconazole 2% gel (Miconaz, oral Medical Union Pharmaceutical, Cairo, Egypt) was applied only in the fourth week of treatment period to avoid secondary candidiosis | Drug | Group II |
Primary outcome
clinical scoring (CS)
Time frame: 2 months/ once per week for one months then after 2 months
0 represented no lesion/normal mucosa; 1, mild white striae/no erythematous area; 2, white striae with atrophic area less than 1 cm²; 3, white striae with atrophic area more than 1 cm²; 4, white striae with erosive area less than 1 4 cm²; and 5, white striae with erosive area more than 1 cm²
visual analog scale (VAS)
Time frame: 2 months/ once per week for one months then after 2 months
Patients also ranked the severity of pain and burning sensation on 100-mm visual analog scale
1 secondary outcome
CD4+,CD8+, CD133
Time frame: baseline and after 1 month treatment
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 13 May 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pimecrolimus 1% cream and Betamethasone 17-valerate 0.1% cream in people with Oral Lichen Planus, 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 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 13 May 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
clinical scoring (CS) (time frame: 2 months/ once per week for one months then after 2 months). The study lists 2 primary outcomes in all. 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 13 May 2015.