The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03877679

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Oral Lichen Planus	Drug: Triamcinolone Drug: Turmeric paste	Phase 1

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessor (CS) and statistician

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: turmeric paste 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).	Drug: Turmeric paste 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 Other Names: Curcumin
Active Comparator: Triamcenolone in orabase Triamcenolone + na ploycarboxylate	Drug: Triamcinolone Triamcenolone +napolycarboxylate Other Names: Triamcenolone in orabase

Arm

Intervention/Treatment

Experimental: turmeric paste

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).

Drug: Turmeric paste

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

Other Names:

Curcumin

Active Comparator: Triamcenolone in orabase

Triamcenolone + na ploycarboxylate

Drug: Triamcinolone

Triamcenolone +napolycarboxylate

Other Names:

Triamcenolone in orabase

Outcome Measures

Primary Outcome Measures

Pain intensity [4 weeks]
measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain

Secondary Outcome Measures

clinical sign score [Baseline , 2nd week and 4th week]
measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
IL-33 level in saliva [base line and 4th week]
by ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.