Oral Lichen PlanusPhase 1NCT03877679
The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
A Phase 1 study testing Triamcinolone and Turmeric paste in people with Oral Lichen Planus, run by Cairo University.
Trial summary
Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus. Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva. Compare the outcome of new preparation with the gold standard treatment (corticosteroids). 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?
- Triamcinolone and Turmeric paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Jun 2020
- Phase
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, 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 controlled diabetes and/or controlled hypertension will be included in the study.
- Patients with no history of taking corticosteroids for the last 6 months
- Patients who agrees to take medication.
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 uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.
About this study
Official title: The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial
Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.
- Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
- Compare the outcome of new preparation with the gold standard treatment (corticosteroids).
Read the detailed description
Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope
1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week
- Conditions
- Oral Lichen Planus
- Being tested
- Triamcinolone, Turmeric paste
- Keywords
- oral lichen planus, curcumin, IL-33, corticosteroids
- 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.
TriamcinoloneDrug
Also called Triamcenolone in orabase
Triamcenolone +napolycarboxylate
Turmeric pasteDrug
Also called Curcumin
Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University
| Study group | Role | What they receive |
|---|---|---|
| turmeric paste | Experimental | Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015). Receives: Drug: Turmeric paste |
| Triamcenolone in orabase | Active comparator | Triamcenolone + na ploycarboxylate Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
Measured: 4 weeks
Secondary outcomes (2)
clinical sign score
measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
Measured: Baseline , 2nd week and 4th week
IL-33 level in saliva
by ELISA
Measured: base line and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed salah abd-elhameed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877679
- Sponsor's protocol ID
- OMED2:5:1
- Status last verified
- Mar 2019
- First submitted
- 24 Sep 2018
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All authors of this trial will have access to the final trial dataset.
Publications
Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
PubMed 12676044Greenberg G, Glick M. Burket's Oral Medicine: Diagnosis and Treatment. Hamilton, Ontario, BC Decker, 11th ed., 2008:90-1
Nosratzehi T, Arbabi-Kalati F, Hamishehkar H, Bagheri S. Comparison of the Effects of Curcumin Mucoadhesive Paste and Local Corticosteroid on the Treatment of Erosive Oral Lichen Planus Lesions. J Natl Med Assoc. 2018 Feb;110(1):92-97. doi: 10.1016/j.jnma.2017.01.011. Epub 2017 May 11.
PubMed 29510851Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Phytomedicine. 2007 Aug;14(7-8):437-46. doi: 10.1016/j.phymed.2007.05.003. Epub 2007 Jul 2.
PubMed 17604143
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03877679
- Acronym / sponsor ID
- OMED2:5:1
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus, curcumin, IL-33, corticosteroids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 18 Mar 2019 (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.
Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.
- Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
- Compare the outcome of new preparation with the gold standard treatment (corticosteroids).
Detailed description
Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope
1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| turmeric paste | Experimental | Drug: Turmeric pasteTopical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015). |
| Triamcenolone in orabase | Active comparator | Drug: TriamcinoloneTriamcenolone + na ploycarboxylate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will be clinically diagnosed as having atrophic \&/or erosive oral lichen planus.
- Patients with controlled diabetes and/or controlled hypertension will be included in the study.
- Patients with no history of taking corticosteroids for the last 6 months
- Patients who agrees to take medication.
Key exclusion criteria (4 listed)
- 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 uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.
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 |
|---|---|---|
| TriamcinoloneAlso: Triamcenolone in orabaseTriamcenolone +napolycarboxylate | Drug | Triamcenolone in orabase |
| Turmeric pasteAlso: CurcuminTopical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University | Drug | turmeric paste |
Primary outcome
Pain intensity
Time frame: 4 weeks
measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
2 secondary outcomes
clinical sign score
Time frame: Baseline , 2nd week and 4th week
IL-33 level in saliva
Time frame: base line and 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 12676044Chainani-Wu N. Safety and anti-inflammatory activity of curcumin: a component of tumeric (Curcuma longa). J Altern Complement Med. 2003 Feb;9(1):161-8. doi: 10.1089/107555303321223035.
- BackgroundGreenberg G, Glick M. Burket's Oral Medicine: Diagnosis and Treatment. Hamilton, Ontario, BC Decker, 11th ed., 2008:90-1
- Background: PubMed 29510851Nosratzehi T, Arbabi-Kalati F, Hamishehkar H, Bagheri S. Comparison of the Effects of Curcumin Mucoadhesive Paste and Local Corticosteroid on the Treatment of Erosive Oral Lichen Planus Lesions. J Natl Med Assoc. 2018 Feb;110(1):92-97. doi: 10.1016/j.jnma.2017.01.011. Epub 2017 May 11.
- Results publication: PubMed 17604143Chainani-Wu N, Silverman S Jr, Reingold A, Bostrom A, Mc Culloch C, Lozada-Nur F, Weintraub J. A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. Phytomedicine. 2007 Aug;14(7-8):437-46. doi: 10.1016/j.phymed.2007.05.003. Epub 2007 Jul 2.
- Individual participant dataSharing planned: Yes. All authors of this trial will have access to the final trial dataset.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Triamcinolone and Turmeric paste in people with Oral Lichen Planus, run by Cairo University.
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 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 18 Mar 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 intensity (time frame: 4 weeks). 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 NCT03877679, which also lists 4 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 18 Mar 2019.