Erosive Lichen PlanusPhase 2/3NCT04652739
Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus
A Phase 2/3 study testing Lycopene Softgel, 10 Mg and Prednisolone in people with Erosive Lichen Planus, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Erosive Lichen Planus
- What is being tested?
- Lycopene Softgel, 10 Mg and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 10 Mar 2019
- Phase
- Phase 2/3
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy
Who cannot join
- Pregnant females and smokers.
- Patients suggestive of having lichenoid contact/drug reactions.
- Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
- Lesions showing histological features of dysplasia.
- Patients with skin lichen planus lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)
The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.
Read the detailed description
Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.
- Conditions
- Erosive Lichen Planus
- Being tested
- Lycopene Softgel, 10 Mg, Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycopene Softgel, 10 MgDrug
Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.
PrednisoloneDrug
Also called Corticosteroids
Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).
| Study group | Role | What they receive |
|---|---|---|
| Lycopene | Experimental | Not described Receives: Drug: Lycopene Softgel, 10 Mg |
| Corticosteroids | Active comparator | Not described Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment was conducted using Visual Analogue Scale (VAS)
Patients were instructed to mark a 10 cm line at a point equivalent to their present pain. The score was determined by measuring the distance in mm on the line from the "no pain" anchor to the patient's mark, providing a range of scores from 0-100. A Pain-free experience was scored zero, while the worst pain was scored 100.
Measured: up to 5 months
Lesion size assessment
Assessment of OLP lesions was performed using the Thongprasom et al. scoring index where:
- Score 0: No lesion/Normal mucosa.
- Score 1: Mild white striae only.
- Score 2: White striae with erythematous area <1cm².
- Score 3: White striae with erythematous area >1cm².
- Score 4: White striae with erosive area <1cm².
- Score 5: White striae with erosive area >1cm².
- Scores from different oral sites were added to give a final score for every patient from 0-50.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Oct 2018
- Primary completion3 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erosive 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Aliaa A Bedeir, BDS, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptAzza M Zaki, PhD, Study director, Faculty of Dentistry, Alexandria University, EgyptSabah A Mahmoud, PhD, Study director, Faculty of Medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652739
- Sponsor's protocol ID
- Lycopene and lichen planus
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
PubMed 1460584Gobbo M, Rupel K, Zoi V, Perinetti G, Ottaviani G, Di Lenarda R, Bevilacqua L, Woo SB, Biasotto M. Scoring systems for Oral Lichen Planus used by differently experienced raters. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e562-e571. doi: 10.4317/medoral.21833.
PubMed 28809373
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04652739
- Acronym / sponsor ID
- Lycopene and lichen planus
- Conditions
- Erosive Lichen Planus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 3 Dec 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.
The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.
Detailed description
Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycopene | Experimental | Drug: Lycopene Softgel, 10 Mg |
| Corticosteroids | Active comparator | Drug: Prednisolone |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy
Key exclusion criteria (5 listed)
- Pregnant females and smokers.
- Patients suggestive of having lichenoid contact/drug reactions.
- Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
- Lesions showing histological features of dysplasia.
- Patients with skin lichen planus lesions.
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 |
|---|---|---|
| Lycopene Softgel, 10 MgPatients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract. | Drug | Lycopene |
| PrednisoloneAlso: CorticosteroidsPatients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone). | Drug | Corticosteroids |
Primary outcome
Pain assessment was conducted using Visual Analogue Scale (VAS)
Time frame: up to 5 months
Patients were instructed to mark a 10 cm line at a point equivalent to their present pain. The score was determined by measuring the distance in mm on the line from the "no pain" anchor to the patient's mark, providing a range of scores from 0-100. A Pain-free experience was scored zero, while the worst pain was scored 100.
Lesion size assessment
Time frame: up to 5 months
Assessment of OLP lesions was performed using the Thongprasom et al. scoring index where: * Score 0: No lesion/Normal mucosa. * Score 1: Mild white striae only. * Score 2: White striae with erythematous area <1cm². * Score 3: White striae with erythematous area >1cm². * Score 4: White striae with erosive area <1cm². * Score 5: White striae with erosive area >1cm². * Scores from different oral sites were added to give a final score for every patient from 0-50.
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 3 Dec 2020.
- Background: PubMed 1460584Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. doi: 10.1111/j.1600-0714.1992.tb00974.x.
- Background: PubMed 28809373Gobbo M, Rupel K, Zoi V, Perinetti G, Ottaviani G, Di Lenarda R, Bevilacqua L, Woo SB, Biasotto M. Scoring systems for Oral Lichen Planus used by differently experienced raters. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e562-e571. doi: 10.4317/medoral.21833.
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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.
Aliaa A Bedeir, BDS principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Azza M Zaki, PhD study director
Faculty of Dentistry, Alexandria University, Egypt
Sabah A Mahmoud, PhD study director
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lycopene Softgel, 10 Mg and Prednisolone in people with Erosive Lichen Planus, run by Nourhan M.Aly at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 3 Dec 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 Egypt. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain assessment was conducted using Visual Analogue Scale (VAS) (time frame: up to 5 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?
On the ClinicalTrials.gov record for NCT04652739, which also lists 2 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 3 Dec 2020.