Oral Lichen PlanusEarly Phase 1(MDA)NCT03738176
The Efficacy of Topical Sesame Oil Versus Topical Triamcinolone on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker [MDA]
A Early Phase 1 study testing Sesame Oil and triamcinolone in orabase in people with Oral Lichen Planus, run by Mona Taha Mohammed MD.
Trial summary
use seseme oil and corticosteroid topically for two groups Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Sesame Oil and triamcinolone in orabase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2019to 30 Dec 2020
- Phase
- Early Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will be clinically diagnosed as having atrophic \&/or erosive oral lichen planus.
- Patients with no history of taking topical corticosteroids for the last 2 months and systemic corticosteroid for the last 6 months
- Patients who agree to take medication and follow up .
Who cannot join
- Pregnant and lactating ladies.
- Patients with history of topical steroids during last 2 months \& systemic steroids during last 6 months.
- Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- Patient with history of diabetes or hypertension or those with positive HCV ab or HBs Ag.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)
use seseme oil and corticosteroid topically for two groups
Read the detailed description
- The enrolled patients will be divided randomly into two groups.
- Test group will receive topical sesame oil (3 times /day after eating) for a month.
- Control group will receive topical corticosteroid (3 times /day after eating) for a month.
- Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires \& by clinical sign score . MDA will be measured at the baseline \& at the end of four weeks after treatment.
- Conditions
- Oral Lichen Planus
- Being tested
- Sesame Oil, triamcinolone in orabase
- Keywords
- Oral lichen planus, sesame oil, corticosteroid, MDA
- 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.
Sesame OilDrug
Also called sesame oil gel
Sesame oil(80 gm NaCMC-20 gmSesame oil)
triamcinolone in orabaseDrug
Also called kenacorte
triamcinolone 140 gm-Na CMC 50 gm
| Study group | Role | What they receive |
|---|---|---|
| sesame oil in orabase | Experimental | 20 gm sesame oil-80 gm CMC 3 times per day for one month Receives: Drug: Sesame Oil |
| triamcinolone in orabase | Active comparator | 140 gm triamcinolone-50 gm Na CMC 3 times per day for one month Receives: Drug: triamcinolone in orabase |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensit measure
measured by visual analogue scale where0 no pain and 10 sever pain
Measured: 4 weeks
reduction of clinical signs measure
Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal
Measured: 4 weeks
Secondary outcomes (1)
Salivary level of oxidative stress biomarker (MDA)
measured by reaction with thiobarbituric acid (TBA)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start16 Dec 2019 (estimated)
- Primary completion16 Nov 2020 (estimated)
- Study completion30 Dec 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sesame oil in orabase(80 gm CMC -20 gm sesame oil)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona Taha Mohammed MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mona Taha Mohammed MD, Cairo University
- Investigators
- Mona Taha Mohammed Ahammed, MD, Principal investigator, Cairo U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738176
- Sponsor's protocol ID
- 2:5:1
- Acronym
- (MDA)
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Sesame Oil in Orabase Versus Topical Triamcinolone in Orabase on Oral Lichen Planus and Salivary Level of Oxidative Stress Biomarker, Malondialdehyde [MDA] : Randomized Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT03738176
- Acronym / sponsor ID
- (MDA) / 2:5:1
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, sesame oil, corticosteroid, MDA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mona Taha Mohammed MDUniversity, hospital or other
- Study start
- 16 Dec 2019 (estimated)
- Primary completion
- 16 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Nov 2018 (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.
use seseme oil and corticosteroid topically for two groups
Detailed description
- The enrolled patients will be divided randomly into two groups.
- Test group will receive topical sesame oil (3 times /day after eating) for a month.
- Control group will receive topical corticosteroid (3 times /day after eating) for a month.
- Assessment of the appearance score and severity of pain as well as the clinical parameter outcome will be done at baseline and at the end of two and four weeks and will be recorded in the patients' questionnaires \& by clinical sign score . MDA will be measured at the baseline \& at the end of four weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- sesame oil in orabase(80 gm CMC -20 gm sesame oil)
| Arm | Type | Receives |
|---|---|---|
| sesame oil in orabase | Experimental | Drug: Sesame Oil20 gm sesame oil-80 gm CMC 3 times per day for one month |
| triamcinolone in orabase | Active comparator | Drug: triamcinolone in orabase140 gm triamcinolone-50 gm Na CMC 3 times per day for one month |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will be clinically diagnosed as having atrophic \&/or erosive oral lichen planus.
Key exclusion criteria (4 listed)
- Pregnant and lactating ladies.
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 |
|---|---|---|
| Sesame OilAlso: sesame oil gelSesame oil(80 gm NaCMC-20 gmSesame oil) | Drug | sesame oil in orabase |
| triamcinolone in orabaseAlso: kenacortetriamcinolone 140 gm-Na CMC 50 gm | Drug | triamcinolone in orabase |
Primary outcome
pain intensit measure
Time frame: 4 weeks
measured by visual analogue scale where0 no pain and 10 sever pain
reduction of clinical signs measure
Time frame: 4 weeks
Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal
1 secondary outcome
Salivary level of oxidative stress biomarker (MDA)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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.
Mona Taha Mohammed Ahammed, MD principal investigator
Cairo U
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sesame Oil and triamcinolone in orabase in people with Oral Lichen Planus, run by Mona Taha Mohammed MD.
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 4 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 2 Aug 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Mona Taha Mohammed Ahamed, Master (01123294474, mona.taha@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensit measure (time frame: 4 weeks). 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 2 Aug 2019.