Clinical trial NCT03877679: The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Oral Lichen Planus
Keywords: oral lichen planus
curcumin
IL-33
corticosteroids
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: clinical sign score
timeFrame: Baseline , 2nd week and 4th week
measure: IL-33 level in saliva
timeFrame: base line and 4th week
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Greenberg G, Glick M. Burket's Oral Medicine: Diagnosis and Treatment. Hamilton, Ontario, BC Decker, 11th ed., 2008:90-1
citation: 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.
citation: Chainani-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.