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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03877679
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Information provided by (Responsible Party):
Mohamed salah abd-elhameed, Cairo University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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 Name: Curcumin

Active Comparator: Triamcenolone in orabase
Triamcenolone + na ploycarboxylate
Drug: Triamcinolone
Triamcenolone +napolycarboxylate
Other Name: Triamcenolone in orabase

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. clinical sign score [ Time Frame: 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

  2. IL-33 level in saliva [ Time Frame: base line and 4th week ]
    by ELISA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Publications of Results:
Other Publications:
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Responsible Party: Mohamed salah abd-elhameed, principal investigator, Cairo University Identifier: NCT03877679    
Other Study ID Numbers: OMED2:5:1
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All authors of this trial will have access to the final trial dataset.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: after study completion
Access Criteria: pubmed

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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
Keywords provided by Mohamed salah abd-elhameed, Cairo University:
oral lichen planus
Additional relevant MeSH terms:
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Enzyme Inhibitors
Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Antineoplastic Agents