Oral Lichen PlanusPhase 2NCT03026478
Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus
A Phase 2 study testing Betamethasone Dipropionate and Clobetasol Propionate in people with Oral Lichen Planus, run by Garlapati Komali at 1 site in India.
Trial summary
Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease characterized by pain and burning sensation. The major types of OLP are the following: reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Betamethasone Dipropionate and Clobetasol Propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 6 May 2016to Jun 2018
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Oral Lichen Planus, who are willing to participate in the study.
- Patients who are physically healthy and well oriented in time, space and as a person.
- Patients clinically and histopathologically diagnosed with Oral Lichen Planus.
- Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.
Who cannot join
- Patients with Oral Lichen Planus, who are not willing to participate in the study.
- Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
- Patients with a known allergy or contraindication to study medications.
- Patients with known history of systemic diseases, where steroids are contraindicated.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Komali Garlapati
Hyderabad, Telangana, 500060
KOMALI GARLAPATI, M.D.S., +918008884945, komali_garlapati@yahoo.co.in
About this study
Official title: A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus
Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease characterized by pain and burning sensation. The major types of OLP are the following: reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely accepted as the primary treatment of choice.Hence this study is designed to evaluate and compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05% in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen Planus.
Read the detailed description
Patients of either sex, irrespective of age attending the Department of Oral Medicine \& Radiology, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre, Hyderabad who are clinically and histopathologically diagnosed with Oral Lichen Planus shall be included in the study group after obtaining an informed consent from the patients.
Study design: Prospective study.
Sample size:
A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.
Methodology:
30 patients who are diagnosed with Oral Lichen Planus by clinical and histopathological examination will be randomly assigned into 2 drug groups and burning sensation will be assessed by VAS Scale and also clinical improvement will be assessed at interval of 1 week till 4 weeks.
GROUP A: This group of patients will receive topical Clobetasol 0.05% in orabase and Clotrimazole 1%.
GROUP B: This group of patients will receive topical Betamethasone 0.05% in orabase and Clotrimazole 1%.
Inclusion criteria:
- Patients with Oral Lichen Planus, who are willing to participate in the study.
- Patients who are physically healthy and well oriented in time, space and as a person.
- Patients clinically and histopathologically diagnosed with Oral Lichen Planus.
- Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.
Exclusion Criteria :
- Patients with Oral Lichen Planus, who are not willing to participate in the study.
- Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
- Patients with a known allergy or contraindication to study medications.
- Patients with systemic diseases, where steroids are contraindicated.
- Pregnant women.
- Conditions
- Oral Lichen Planus
- Being tested
- Betamethasone Dipropionate, Clobetasol Propionate
- Keywords
- oral lichen planus, betamethasone, clobetasol, orabase
- 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.
Betamethasone DipropionateDrug
Also called Betamethasone Dipropionate 0.05% gel
Clobetasol PropionateDrug
Also called Clobetasole Propionate 0.05% gel
| Study group | Role | What they receive |
|---|---|---|
| Betamethasone dipropionate 0.05% | Experimental | topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month Receives: Drug: Betamethasone Dipropionate |
| Clobetasol propionate 0.05% | Active comparator | Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month Receives: Drug: Clobetasol Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Based on Visual analog scale and size of the lesion
study is in progress
Measured: Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start6 May 2016
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Garlapati Komali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Garlapati Komali, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Investigators
- KOMALI GARLAPATI, Principal investigator, PMVIDS & RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026478
- Sponsor's protocol ID
- PMVIDS&RC/IEC/OMR/DN/0003-15
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT03026478
- Acronym / sponsor ID
- PMVIDS&RC/IEC/OMR/DN/0003-15
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, betamethasone, clobetasol, orabase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Garlapati KomaliUniversity, hospital or other
- Study start
- 6 May 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 20 Jan 2017 (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 an autoimmune, chronic inflammatory mucocutaneous disease characterized by pain and burning sensation. The major types of OLP are the following: reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely accepted as the primary treatment of choice.Hence this study is designed to evaluate and compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05% in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen Planus.
Detailed description
Patients of either sex, irrespective of age attending the Department of Oral Medicine \& Radiology, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre, Hyderabad who are clinically and histopathologically diagnosed with Oral Lichen Planus shall be included in the study group after obtaining an informed consent from the patients.
Study design: Prospective study.
Sample size:
A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.
Methodology:
30 patients who are diagnosed with Oral Lichen Planus by clinical and histopathological examination will be randomly assigned into 2 drug groups and burning sensation will be assessed by VAS Scale and also clinical improvement will be assessed at interval of 1 week till 4 weeks.
GROUP A: This group of patients will receive topical Clobetasol 0.05% in orabase and Clotrimazole 1%.
GROUP B: This group of patients will receive topical Betamethasone 0.05% in orabase and Clotrimazole 1%.
Inclusion criteria:
- Patients with Oral Lichen Planus, who are willing to participate in the study.
- Patients who are physically healthy and well oriented in time, space and as a person.
- Patients clinically and histopathologically diagnosed with Oral Lichen Planus.
- Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.
Exclusion Criteria :
- Patients with Oral Lichen Planus, who are not willing to participate in the study.
- Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
- Patients with a known allergy or contraindication to study medications.
- Patients with systemic diseases, where steroids are contraindicated.
- Pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Betamethasone dipropionate 0.05% | Experimental | Drug: Betamethasone Dipropionatetopical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month |
| Clobetasol propionate 0.05% | Active comparator | Drug: Clobetasol PropionateTopical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Oral Lichen Planus, who are willing to participate in the study.
- Patients who are physically healthy and well oriented in time, space and as a person.
- Patients clinically and histopathologically diagnosed with Oral Lichen Planus.
- Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.
Key exclusion criteria (5 listed)
- Patients with Oral Lichen Planus, who are not willing to participate in the study.
- Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
- Patients with a known allergy or contraindication to study medications.
- Patients with known history of systemic diseases, where steroids are contraindicated.
- Pregnant women.
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 |
|---|---|---|
| Betamethasone DipropionateAlso: Betamethasone Dipropionate 0.05% gel | Drug | Betamethasone dipropionate 0.05% |
| Clobetasol PropionateAlso: Clobetasole Propionate 0.05% gel | Drug | Clobetasol propionate 0.05% |
Primary outcome
Based on Visual analog scale and size of the lesion
Time frame: Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.
study is in progress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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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.
KOMALI GARLAPATI principal investigator
PMVIDS & RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betamethasone Dipropionate and Clobetasol Propionate in people with Oral Lichen Planus, run by Garlapati Komali at 1 site in India.
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 4 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 14 Mar 2018. 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 India. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 KOMALI GARLAPATI, Professor (+918008884945, komali_garlapati@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Based on Visual analog scale and size of the lesion (time frame: Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.). 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 14 Mar 2018.