Honey-and-orabase paste versus steroid paste for symptomatic oral lichen planus
Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
PHASE2; PHASE3 · Dar Al Uloom University · NCT06988527
This trial will see if honey mixed with orabase can reduce symptoms and improve quality of life for adults with erosive or atrophic oral lichen planus compared with standard triamcinolone paste.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | All |
| Sponsor | Dar Al Uloom University (other) |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT06988527 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial enrolled 56 adults aged 35–60 with symptomatic erosive or atrophic oral lichen planus and compared a honey-in-orabase 1:1 paste to standard triamcinolone acetonide 0.1% treatment. Participants applied the assigned topical paste daily for four months, attended clinic visits every two weeks for monitoring and testing, and kept a symptom diary. Key exclusions included other oral mucosal diseases, systemic conditions affecting wound healing, use of systemic corticosteroids or immunosuppressants, allergy to honey or triamcinolone, and pregnancy or lactation. Outcomes included symptom change and patient-reported quality of life measures.
Who should consider this trial
Good fit: Adults aged 35–60 with clinically diagnosed symptomatic erosive or atrophic oral lichen planus who can follow study procedures and provide informed consent.
Not a fit: People with other oral mucosal disorders, systemic conditions that affect healing, allergies to honey or triamcinolone, current systemic immunosuppression, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the honey paste could reduce symptoms and improve quality of life while offering a nonsteroidal topical alternative for OLP patients.
How similar studies have performed: Small trials and case reports have suggested topical honey can aid mucosal healing and symptom relief, but evidence is limited compared with established topical steroids.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Riyadh
- Dar AlUloom University — Riyadh, Saudi Arabia (RECRUITING)
Study contacts
- Principal investigator: Sally A ElHaddad, Assist. Prof — Dar AlUloom University, SA
- Study coordinator: Sally A ElHaddad, Assist Prof
- Email: s.elhaddad@dau.edu.sa
- Phone: 00966011494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erosive Oral Lichen Planus, Atrophic Lichen Planus