Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

NCT04193748 | Completed Phase 4

• 1 other identifier: FacultyofDentistryCairoUni
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

Conditions

Oral Lichen Planus

Keywords

pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS)

  Pain assessment scale

  4 weeks

Secondary Outcomes (2)

• Sign score

  4 weeks

• OHIP-14 questionnaire

  4 weeks

Study Arms (3)

Control group

ACTIVE COMPARATOR

Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.

Drug: Topical pomegranate seeds and peel extracts

Group S

EXPERIMENTAL

Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.

Drug: Topical pomegranate seeds and peel extracts

Group P

EXPERIMENTAL

Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.

Drug: Topical pomegranate seeds and peel extracts

Interventions

Topical pomegranate seeds and peel extracts DRUG

Topical pomegranate seeds and peel extracts in the form of gel

Control group; Group P; Group S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Oral Medicine and Periodontology Department

Cairo, Egypt

Location

Faculty of Dentistry, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral; Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2019
• Primary Completion: November 20, 2019
• Study Completion: December 13, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)