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NCT06327620
Treatment Of Oral Lichen Planus
NA trial testing Daivobet ointment, topical steroids in Lichen Planus in 15 participants. Status unknown.
20 May 2024
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 January 2022 |
| Primary completion | 20 May 2024 |
| Estimated completion | 20 May 2024 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Daivobet ointment, topical steroids
Conditions studied
- Lichen Planus — all drugs for Lichen Planus →
Sponsor
Mansoura University
Who can join
Adults 30 to 60, any sex, with Lichen Planus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris. The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks. Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug. Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis. The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06327620
- Europe PMC full search
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Related trials
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Currently open trials in the same condition.
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- NCT05928169 — Determinants of Chronic Inflammatory Skin Disease Trajectories · recruiting
- NCT00542373 — Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for De · NA · active not recruiting
Other Mansoura University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06327620 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 25 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06327620.
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