search
Back to results

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

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Triamcinolone
Turmeric paste
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring oral lichen planus, curcumin, IL-33, corticosteroids

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    turmeric paste

    Triamcenolone in orabase

    Arm Description

    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).

    Triamcenolone + na ploycarboxylate

    Outcomes

    Primary Outcome Measures

    Pain intensity
    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
    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
    by ELISA

    Full Information

    First Posted
    September 24, 2018
    Last Updated
    March 14, 2019
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03877679
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    May 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. 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).
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    oral lichen planus, curcumin, IL-33, corticosteroids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Outcome assessor (CS) and statistician
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    turmeric paste
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Triamcenolone in orabase
    Arm Type
    Active Comparator
    Arm Description
    Triamcenolone + na ploycarboxylate
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone
    Other Intervention Name(s)
    Triamcenolone in orabase
    Intervention Description
    Triamcenolone +napolycarboxylate
    Intervention Type
    Drug
    Intervention Name(s)
    Turmeric paste
    Other Intervention Name(s)
    Curcumin
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    clinical sign score
    Description
    measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
    Time Frame
    Baseline , 2nd week and 4th week
    Title
    IL-33 level in saliva
    Description
    by ELISA
    Time Frame
    base line and 4th week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All authors of this trial will have access to the final trial dataset.
    IPD Sharing Time Frame
    after study completion
    IPD Sharing Access Criteria
    pubmed
    Citations:
    PubMed Identifier
    12676044
    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.
    Results Reference
    background
    Citation
    Greenberg G, Glick M. Burket's Oral Medicine: Diagnosis and Treatment. Hamilton, Ontario, BC Decker, 11th ed., 2008:90-1
    Results Reference
    background
    PubMed Identifier
    29510851
    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.
    Results Reference
    background
    PubMed Identifier
    17604143
    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.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs