Oral Lichen PlanusPhase 4NCT04278599
Effect of Oral Zinc Supplementation as an Adjuvant to Topical Corticosteroid in Oral Lichen Planus Patients
A Phase 4 study testing Oral Zinc supplementation in people with Oral Lichen Planus, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Oral Zinc supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jan 2020to 30 Sep 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinically and histopathologically proven cases of erosive and atrophic OLP.
- Patients who are willing to participate in the study.
Who cannot join
- Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
- Patients consuming drugs for the treatment of OLP in the past 6 months.
- Suspected lichenoid reaction associated with drugs and restorations.
- Patients whose histopathological findings indicate moderate to severe dysplasia.
- Patients with acquired and congenital immuno-deficiency disorders like AIDS, chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis. These patients are excluded because of difficulty in their biopsy procedure, control of infection, possible interaction with clinical findings of OLP, and their potential doubtful cooperation.
- Patients with systemic diseases involving the gastro-intestinal tract.
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- Known cases of Acrodermatitis enteropathica where difficulty in zinc absorption persists.
- Presence of factors that can alter the absorption of zinc like consumption of calcium tablets, iron supplements and high protein diet.
- Pregnancy and lactation phase
- Alcoholic patients, since alcoholism results in intracellular zinc deficiency.
- Recorded allergy to zinc and/or corticosteroids.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Sanjay TEWARI, 01262283876, principalpgids@yahoo.in
About this study
Official title: Comparative Evaluation of Effect of Oral Zinc Supplementation and Placebo as an Adjuvant to Topical Corticosteroid Therapy in Oral Lichen Planus Patients
Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state.
This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.
Read the detailed description
Lichen planus is a chronic muco-cutaneous disorder of the stratified squamous epithelium that affects the oral and genital mucous membrane, skin, hair, nails and scalp.OLP is the mucosal counterpart of cutaneous lichen planus.The disease was first described by Erasmus Wilson in 1866. The prevelance of disease in the Indian sub-continent is about 2.6%,with the mean age being 30-60 years and with a female predilection. The cutaneous form is more persistent and resistant to treatment while OLP is more frequent in occurrence.
OLP is a potentially pre-malignant oral epithelial lesion. It is a T-cell mediated auto-immune disease in which the auto-cytotoxic CD8 + T cells trigger the apoptosis of the basal cells of oral epithelium.OLP is an idiopathic disease, although there are certain precipitating factors like HLA-A3, anxiety \& stress, diabetes and hypertension.
OLP occurs bilaterally, the most common sites being buccal mucosa, tongue, lips, gingiva, floor of mouth and palate. Wickham's striae are a pathogonomic feature. It has six clinical presentations- Reticular, Erosive, Atrophic, Plaque-like, Papular and Bullous.The reticular form is most common but its asymptomatic, while the erosive form is most severe with symptoms ranging from mild burning to severe pain. The range of MTR for OLP is about 0-5%, with the highest rate for erosive and atrophic types.Erosive OLP lesions arise as a complication of the atrophic process after trauma or ulceration. Appear as a central area of erosion with yellowish fibrinous exudate surrounded by erythema, with Wickham's striae in the periphery. Atrophic OLP lesions appear bright red due to loss of epithelium.
A review study done on the recent concepts in the treatment of OLP concluded that corticosteroids (mostly topical, rarely systemic) continue to be the mainstay of management of OLP. However, there are some other drugs which have a significant contribution such as- Calcineurin inhibitors (cyclosporine, tacrolimus, pimecrolimus), Retinoids, Dapsone, Hydroxychloroquine, Mycophenolate mofetil and Enoxaprin. The non-pharmacological treatment modalities include PUVA therapy, photodynamic therapy and laser therapy.
A recently conducted study found out that serum zinc levels were significantly decreased in patients with erosive OLP in comparison with patients of non-erosive OLP, which may be responsible for disintegration of epithelium in erosive OLP lesions.
The association of OLP and zinc lies in the fact that zinc is associated with the regeneration of epithelium, enhancement of enzyme activity, contributes to protein structure, helps in wound healing as well as inhibition and stimulation of lymphocyte reaction.The deficiency of zinc also leads to compromised T-cell mediated immune defence.Zinc also has anti-oxidant and anti-inflammatory properties, which can decrease apoptosis and transformation to a malignant state.
Thus, the present study intends to evaluate the role of oral zinc supplementation as an adjuvant to topical corticosteroid therapy on the treatment of oral lichen planus.
- Conditions
- Oral Lichen Planus
- Being tested
- Oral Zinc supplementation, Oral placebo supplementation
- 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.
Oral Zinc supplementationDrug
Also called Zinc Acetate
In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
Oral placebo supplementationDrug
Also called Placebo
In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion. Receives: Drug: Oral Zinc supplementation |
| Control group | Placebo comparator | The patients will be administered Placebo tablets for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion. Receives: Drug: Oral placebo supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of changes in size of the lesion
Thongprasom score (TS) will be used to assess changes in the size of the lesion. Digital Vernier callipers will be used to measure the largest dimension of ulcers at baseline and at each follow-up visit.
Measured: Baseline, 6 weeks and 3 months.
Assessment of changes in pain and burning sensation of the lesion.
Visual Analogue Scale (VAS) will be used to assess changes in pain and burning sensation of the lesion.
Measured: Baseline, 6 weeks and 3 months
Assessment of changes in changes in erythema and ulceration.
Modified Oral Mucositis Index (MOMI)- will be used to assess changes in erythema and ulceration.
Measured: Baseline, 6 weeks and 3 months
Assessment of quality of life of the patient.
Oral Health Impact Profile -14 index (OHIP-14) will be used to assess the quality of life of the patient.
Measured: Baseline, 6 weeks and 3 months
Secondary outcomes (3)
Number of episodes of new lesions in the follow-up period.
The frequency of episodes of new lesions in the follow-up period will be assessed by visual examination
Measured: Baseline, 6 weeks and 3 months
Adverse effects of oral zinc supplementation.
The will adverse effects of oral zinc supplementation.be assessed by interviewing the patients
Measured: Baseline, 6 weeks and 3 months
Requirement for additional systemic steroid therapy.
The requirement for additional systemic steroid therapy will be decided by the presence of non-healing ulcers with persistent VAS scores
Measured: Baseline, 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start15 Jan 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shagun Solanki, Principal investigator, Post Graduate Institute of Dental Sciences, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278599
- Sponsor's protocol ID
- shagun257
- Status last verified
- Jul 2020
- First submitted
- 18 Feb 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Effect of Oral Zinc Supplementation and Placebo as an Adjuvant to Topical Corticosteroid Therapy in Oral Lichen Planus Patients
- ClinicalTrials.gov ID
- NCT04278599
- Acronym / sponsor ID
- shagun257
- Conditions
- Oral Lichen Planus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 20 Feb 2020 (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.
Lichen planus is an auto-immune, chronic inflammatory disease that affects mucosal and cutaneous tissue. Erosive and atrophic oral lichen planus (OLP) are difficult to manage because patients present with symptoms ranging from episodic pain to severe discomfort and they have the highest malignant transformation rate (MTR) amongst all the forms of OLP. Zinc is associated with regeneration of epithelium, wound healing and mediating T-lymphocyte function; all of which can lead to healing and re-epithelisation in the lesions of erosive OLP. Besides this, it also has anti-oxidant and anti-inflammatory properties, which lead to decrease in apoptosis and transformation into a malignant state.
This study intends to evaluate the effect of oral zinc supplements as an adjuvant to the topical corticosteroid therapy in the treatment of OLP.
Detailed description
Lichen planus is a chronic muco-cutaneous disorder of the stratified squamous epithelium that affects the oral and genital mucous membrane, skin, hair, nails and scalp.OLP is the mucosal counterpart of cutaneous lichen planus.The disease was first described by Erasmus Wilson in 1866. The prevelance of disease in the Indian sub-continent is about 2.6%,with the mean age being 30-60 years and with a female predilection. The cutaneous form is more persistent and resistant to treatment while OLP is more frequent in occurrence.
OLP is a potentially pre-malignant oral epithelial lesion. It is a T-cell mediated auto-immune disease in which the auto-cytotoxic CD8 + T cells trigger the apoptosis of the basal cells of oral epithelium.OLP is an idiopathic disease, although there are certain precipitating factors like HLA-A3, anxiety \& stress, diabetes and hypertension.
OLP occurs bilaterally, the most common sites being buccal mucosa, tongue, lips, gingiva, floor of mouth and palate. Wickham's striae are a pathogonomic feature. It has six clinical presentations- Reticular, Erosive, Atrophic, Plaque-like, Papular and Bullous.The reticular form is most common but its asymptomatic, while the erosive form is most severe with symptoms ranging from mild burning to severe pain. The range of MTR for OLP is about 0-5%, with the highest rate for erosive and atrophic types.Erosive OLP lesions arise as a complication of the atrophic process after trauma or ulceration. Appear as a central area of erosion with yellowish fibrinous exudate surrounded by erythema, with Wickham's striae in the periphery. Atrophic OLP lesions appear bright red due to loss of epithelium.
A review study done on the recent concepts in the treatment of OLP concluded that corticosteroids (mostly topical, rarely systemic) continue to be the mainstay of management of OLP. However, there are some other drugs which have a significant contribution such as- Calcineurin inhibitors (cyclosporine, tacrolimus, pimecrolimus), Retinoids, Dapsone, Hydroxychloroquine, Mycophenolate mofetil and Enoxaprin. The non-pharmacological treatment modalities include PUVA therapy, photodynamic therapy and laser therapy.
A recently conducted study found out that serum zinc levels were significantly decreased in patients with erosive OLP in comparison with patients of non-erosive OLP, which may be responsible for disintegration of epithelium in erosive OLP lesions.
The association of OLP and zinc lies in the fact that zinc is associated with the regeneration of epithelium, enhancement of enzyme activity, contributes to protein structure, helps in wound healing as well as inhibition and stimulation of lymphocyte reaction.The deficiency of zinc also leads to compromised T-cell mediated immune defence.Zinc also has anti-oxidant and anti-inflammatory properties, which can decrease apoptosis and transformation to a malignant state.
Thus, the present study intends to evaluate the role of oral zinc supplementation as an adjuvant to topical corticosteroid therapy on the treatment of oral lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Oral Zinc supplementationThe patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion. |
| Control group | Placebo comparator | Drug: Oral placebo supplementationThe patients will be administered Placebo tablets for 6 weeks from the baseline. Topical corticosteroid paste will be prescribed according to the intensity of the lesion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically and histopathologically proven cases of erosive and atrophic OLP.
- Patients who are willing to participate in the study.
Key exclusion criteria (11 listed)
- Patients with reticular form of OLP and OLP with muco-cutaneous involvement.
- Patients consuming drugs for the treatment of OLP in the past 6 months.
- Suspected lichenoid reaction associated with drugs and restorations.
- Patients whose histopathological findings indicate moderate to severe dysplasia.
- Patients with acquired and congenital immuno-deficiency disorders like AIDS, chemotherapy, addiction to injectable opioids like hemophilia and blood dialysis. These patients are excluded because of difficulty in their biopsy procedure, control of infection, possible interaction with clinical findings of OLP, and their potential doubtful cooperation.
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 |
|---|---|---|
| Oral Zinc supplementationAlso: Zinc AcetateIn the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months. | Drug | Test group |
| Oral placebo supplementationAlso: PlaceboIn the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months. | Drug | Control group |
Primary outcome
Assessment of changes in size of the lesion
Time frame: Baseline, 6 weeks and 3 months.
Thongprasom score (TS) will be used to assess changes in the size of the lesion. Digital Vernier callipers will be used to measure the largest dimension of ulcers at baseline and at each follow-up visit.
Assessment of changes in pain and burning sensation of the lesion.
Time frame: Baseline, 6 weeks and 3 months
Visual Analogue Scale (VAS) will be used to assess changes in pain and burning sensation of the lesion.
Assessment of changes in changes in erythema and ulceration.
Time frame: Baseline, 6 weeks and 3 months
Modified Oral Mucositis Index (MOMI)- will be used to assess changes in erythema and ulceration.
Assessment of quality of life of the patient.
Time frame: Baseline, 6 weeks and 3 months
Oral Health Impact Profile -14 index (OHIP-14) will be used to assess the quality of life of the patient.
3 secondary outcomes
Number of episodes of new lesions in the follow-up period.
Time frame: Baseline, 6 weeks and 3 months
Adverse effects of oral zinc supplementation.
Time frame: Baseline, 6 weeks and 3 months
Requirement for additional systemic steroid therapy.
Time frame: Baseline, 6 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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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.
Shagun Solanki principal investigator
Post Graduate Institute of Dental Sciences, Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Zinc supplementation in people with Oral Lichen Planus, run by Postgraduate Institute of Dental Sciences Rohtak 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 2 inclusion and 11 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 21 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Tewari (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in size of the lesion (time frame: Baseline, 6 weeks and 3 months.). The study lists 4 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 21 Jul 2020.