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Phase 3 N=23 Randomized Triple-blind Treatment

Use of Topical NSAID to Reduce Pain in Oral Lichen Planus and Oral Lichenoid Lesions.

Oral Lichen Planus · Oral Lichenoid Mucositis · Oral Lichenoid Reaction

Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score. — 6.4; 12.3 mm

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Ibuprofen suspension 5mg/100ml (Drug); Placebos (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Jan 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Self-reported Pain Scores Using 100m Visual Analog Scale 0-100 Pain Score.
6.4; 12.3

Summary

Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. Current treatments for lichen planus and lichenoid mucositis are usually directed towards reducing the symptoms. This double-blinded cross-over placebo-controlled clinical trial is designed to measure the effectiveness of a topical NSAID (Ibuprofen suspension - 100mg/5ml) compared with a placebo in reducing pain associated with Oral Lichen Planus and Oral Lichenoid Lesions. Exclusion criteria include: * The occurrence of dysplasia in the histopathological specimen * Known or suspected sensitivity to NSAID medication * History of asthma * History of gastrointestinal ulceration * History of bleeding disorders * Pregnancy Outcome measures are self-reported pain scores at day 0, day 4 and day 7 of use of the placebo or active suspension, using a horizontal 100 mm, visual analog scale (VAS). If subjects were already on active treatment at the time of enrollment, they will be asked to discontinue for 7 days for a washout period before starting the research study. cord their spontaneous pain level on a 0-10 VAS. Participants will be contacted initially after the first day of the intervention to discuss any concerns or questions. Every week, reminder phone calls will be made to the subjects to fill out the forms from the investigator and to check for any side effects from the intervention. Both the patient and the investigator will be blinded for the content of each bottle.

Eligibility Criteria

Inclusion Criteria

  • Speak English
  • Have a symptomatic form of the disease.
  • Are at least 18 years of age.

Exclusion Criteria

  • Known or suspected sensitivity to non-steroidal anti-inflammatory medication
  • History of asthma
  • History of gastrointestinal ulceration
  • History of bleeding disorders
  • Use of anti-inflammatory agents in the last 24 hours
  • Use of systemic steroid medication in the last 14 days.
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03509675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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