Topical Erythropoietin Hydrogel in Management of Oral Lichen Planus

NCT06135259 | Unknown Phase 3 FDA Drug

• 1 other identifier: FDASU-RecIR022222
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the clinical efficacy of erythropoietin gel containing a solution of 4000 units with triamcinolone acetonide 0.1% gel in the treatment of symptomatic oral lichen planus (OLP)

Conditions

Oral Lichen Planus

Keywords

erythropoietin gel; tumor necrosis factor; oral lichen planus

Outcome Measures

Primary Outcomes (3)

• Clinical Scoring

  The marker lesion in each patient will be assessed for areas of reticulation, erosion, and ulceration by visual examination and the scoring will be recorded as follow: 0: Mild represented no lesion/normal mucosa. 1. White striae/no erythematous area. 2. White striae with atrophic area less than 1 cm2 3. White striae with atrophic area of more than 1 cm2 4. White striae with an erosive area less than 1 cm2 5. White striae with an erosive area of more than 1cm2

  The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

• Visual Analogue Score

  The Visual Analogue Score consisted of a 10-cm horizontal line marked 0-10 (0 no pain; 10 most severe pain experienced). Patients will mark the scale at each visit. The Visual Analogue Score is then scored by measuring from the patient's mark to the beginning of the scale in cm, and all Visual Analogue Score will be included on one sheet of paper allowing the patient to think in terms of change instead of absolutes.

  The assessment will be carried out at baseline, 1 month and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

• Imaging and measuring surface area of the oral lesion

  Standardized photographs of the oral marker lesion for each patient will be taken with the same digital camera and setting, and the surface area of the lesion will be outlined and measured using specific image software.

  The assessment will be carried out at baseline, 1 and 2 months after starting the treatment protocol and then at 3 months after the end of the observational period

Secondary Outcomes (1)

• Tumor necrosis factor Salivary level

  The Salivary Sample for each patient will be taken at baseline and after 2 months treatment period.

Study Arms (2)

erythropoietin mucoadhesive thermosensitive hydrogel

EXPERIMENTAL

erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan (5%) and glycerophosphate (20%).

Drug: erythropoietin

Triamcinolone Mucoadhesive gel

ACTIVE COMPARATOR

Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Drug: Triamcinolone acetonide

Interventions

erythropoietin DRUG

erythropoietin solutions of 150, 300, and 500 IU/mL were mixed with trimethyl chitosan (M) solutions. glycerophosphate solution was then added to the mixture to obtain erythropoietin-loaded hydrogel comprising final concentrations of trimethyl chitosan(5%) and glycerophosphate (20%).

Also known as: erythropoietin mucoadhesive thermosensitive hydrogel

erythropoietin mucoadhesive thermosensitive hydrogel

Triamcinolone acetonide DRUG

Each 0.1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Also known as: Triamcinolone Mucoadhesive gel

Triamcinolone Mucoadhesive gel

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically proven painful symptomatic forms of OLP confirmed by the presence of red or erythematous changes, or shallow ulcerations with fine lacy lines at the periphery of the lesion accentuated by stretching and not eliminated by rubbing (Wickham's striae)
• Histopathological proven symptomatic OLP

You may not qualify if:

• History of the drug-induced lichenoid lesion.
• Presence of systemic conditions as; serious active or recurrent infections, malignancy, diabetes mellitus, hypertension, or significant heart, liver, or renal diseases. Assessed using a medical questionnaire guided by the Cornell Medical Index
• Smoking
• Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation as mentioned in history
• Pregnancy or breastfeeding.
• History of previous treatments potentially effective on OLP such as antimalarial agents, retinoids, corticosteroids, or immunosuppressive drugs from less than 2 weeks for topical medications, and 4 weeks for systemic medications before starting the study
• Loss of pliability or flexibility in the tissues involved by the lesions of OLP.
• Histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.
• Patients with extensive skin lesions and indicated for systemic corticosteroids.
• Vulnerable groups (Handicapped, orphans, or prisoners)

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Erythropoietin; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yasmine A Fouad, Ph.D

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmine A Fouad, Ph.D

CONTACT

01005793929; dr.yasminefouad@gmail.com

ola M ezzat, Ass.professor

CONTACT

01287944769; dr.ola@asfd.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: May 20, 2024
• Primary Completion: July 23, 2024
• Study Completion: September 23, 2024
• Last Updated: February 1, 2024

Record last verified: 2023-04