Oral Lichen PlanusPhase 2NCT02106468
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus
A Phase 2 study testing Prednisone tablet 5mg and Omega-3 soft capsules 1000 mg in people with Oral Lichen Planus, run by October 6 University at 1 site in Egypt.
Trial summary
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Prednisone tablet 5mg and Omega-3 soft capsules 1000 mg
- 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 siteEgypt
- Study dates
- May 2013to Feb 2015
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
- Age between 30-60 years
- Ability to complete the present clinical trial.
Who cannot join
- Pregnant or breast feeding women (pregnancy test for women of child bearing age).
- Lichenoid reactions caused by certain drugs or dental amalgam.
- Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
- Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
- Presence of candidiasis before treatment.
- Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
- Hypertensive patients
- Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.
- Conditions
- Oral Lichen Planus
- Being tested
- Prednisone tablet 5mg, Omega-3 soft capsules 1000 mg
- Keywords
- Oral Lichen Planus, Corticosteroid, Omega -3
- 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.
Prednisone tablet 5mgDrug
Also called Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy
This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.
Omega-3 soft capsules 1000 mgDrug
Also called Super Omega; Technopharma, Cairo, Egypt
This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| prednisone 50 mg tablet | Active comparator | This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks. Receives: Drug: Prednisone tablet 5mg |
| Omega-3 capsules 1000 mg | Active comparator | This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months. Receives: Drug: Omega-3 soft capsules 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve quality of the life (Oral Health Impact Profile)
Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.
Measured: 6 months
Secondary outcomes (3)
Size and types (atrophic/erosive) of the lesions
Size and types of the lesions were examined at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy.
Score 5 = white striae with erosive area more than I cm Score 4 = white striae with erosive area less than 1 cm Score 3 = white striae with atrophic area more than I cm Score 2 = white striae with atrophic area less than I cm Score I =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa
Measured: 6 months
Pain score (Visual analogue scale (VAS)),
Pain score was recorded at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy.
Scale 0: no pain: VAS=0 Scale 1: mild pain: 0< VAS≤3.5 Scale 2: moderate pain: 3.5 <VAS≤7 Scale 3: severe pain: 7< VAS≤10.
Measured: 6 months
Recurrence of disease
Recurrence within the following 3 months was recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionFeb 2015
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Elgendy, October 6 University
- Investigators
- Enas Elgendy, ph.D, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106468
- Sponsor's protocol ID
- Elgendy - 1
- Status last verified
- Mar 2014
- First submitted
- 21 Mar 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT02106468
- Acronym / sponsor ID
- Elgendy - 1
- Conditions
- Oral Lichen Planus
- Keywords
- Oral Lichen Planus, Corticosteroid, Omega -3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Apr 2014 (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.
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone 50 mg tablet | Active comparator | Drug: Prednisone tablet 5mgThis group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks. |
| Omega-3 capsules 1000 mg | Active comparator | Drug: Omega-3 soft capsules 1000 mgThis group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines).
- Age between 30-60 years
- Ability to complete the present clinical trial.
Key exclusion criteria (8 listed)
- Pregnant or breast feeding women (pregnancy test for women of child bearing age).
- Lichenoid reactions caused by certain drugs or dental amalgam.
- Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
- Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
- Presence of candidiasis before treatment.
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 |
|---|---|---|
| Prednisone tablet 5mgAlso: Delta-cortene Fort®, Lepetit, Carmano, Melano, ItalyThis group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks. | Drug | prednisone 50 mg tablet |
| Omega-3 soft capsules 1000 mgAlso: Super Omega; Technopharma, Cairo, EgyptThis group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months. | Drug | Omega-3 capsules 1000 mg |
Primary outcome
Improve quality of the life (Oral Health Impact Profile)
Time frame: 6 months
Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.
3 secondary outcomes
Size and types (atrophic/erosive) of the lesions
Time frame: 6 months
Pain score (Visual analogue scale (VAS)),
Time frame: 6 months
Recurrence of disease
Time frame: 3 months
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 28 Apr 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.
Enas Elgendy, ph.D principal investigator
October 6 University
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 Prednisone tablet 5mg and Omega-3 soft capsules 1000 mg in people with Oral Lichen Planus, run by October 6 University 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 3 inclusion and 8 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 28 Apr 2015. 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 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?
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?
Improve quality of the life (Oral Health Impact Profile) (time frame: 6 months). 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 28 Apr 2015.