Dar AlUloom University
Riyadh, 11512, Saudi Arabia
Location status: Recruiting
Recruiting
NCT Number: NCT06988527
Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life:
The research question aims to answer:
Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life?
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
35 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients with a clinical diagnosis of oral lichen planus
- Symptomatic OLP lesions (erosive/atrophic)
- Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.
Exclusion criteria
- Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
- Patients who administer systemic corticosteroids or immunosuppressive agents.
- Pregnancy or lactation
- Inability to comprehend or adhere to study directives
- Patients who are not able to sign an informed written consent
Treatment and study plan
Honey in orabase 1: 1 paste
DrugThe experimental drug was manufactured and packed at the Faculty of Pharmacy, Price Sattam University, SA. Production of a mucoadhesive paste involves a step-by-step process. in the final step, honey, comprising 50% of the total composition was thoroughly blended with the prepared base to ensure homogeneity
Other names: Triamcinolone acetonide 0.1% ointment
Primary outcomes
-
Clinical Assessment of OLP lesions using OLP score
Time frame: baseline to 1 year
will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area < 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area < 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface.
-
Pain assessment using Visual analogue scale (VAS)
Time frame: baseline- to 1 year
(VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters)
Secondary outcomes
-
Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment
Time frame: baseline to 1 year
Patient Satisfaction: Measured using a Likert scale questionnaire (e.g., 1-5, where 1 = very dissatisfied and 5 = very satisfied).
Recurrence % or Complications
Quality of Life: Reassess by using OHIP-14 at each follow-up.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Dar Al Uloom University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 25, 2025
- Registry last updated
- Feb 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
NCT05951361
Erosive Oral Lichen Planus
Alexandria, Alexandria Governorate, Egypt
View Trial Details
Completed
Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
NCT03293368
Erosive Oral Lichen Planus, Lichen Planus
Cairo, Egypt
View Trial Details