E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral lichen planus |
Oral lichen planus |
|
E.1.1.1 | Medical condition in easily understood language |
Oral lichen planus is a common chronic inflammatory disease of the oral
mucosa. It can cause symptoms ranging from mild discomfort to severe
pain with difficulty eating and speaking. |
Oral lichen planus är en vanlig kronisk inflammatorisk sjukdom i
munslemhinnan. Det kan orsaka symtom som sträcker sig från lätt
obehag till svår smärta med svårigheter att äta och tala. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030983 |
E.1.2 | Term | Oral lichen planus |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the treatment effect of mouthwash with clobetasol
compared to placebo in symptomatic oral lichen planus. |
Att undersöka behandlingseffekten av munsköljning med klobetasol
jämfört med placebo vid symptomgivande oral lichen planus. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the presence of candida in lichen lesions. |
Att undersöka förekomst av candida i lichen lesioner. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Symptomatic Oral lichen planus.
2. Age > 40 years |
1. Symptomgivande oral lichen planus.
2. Ålder > 40 år. |
|
E.4 | Principal exclusion criteria |
1. Lichenoid contact reactions.
2. Graft versus host disease.
3. Plaque-associated lichenoid reaction.
4. Intraoral diseases with blisters.
5. Ongoing treatment with antibiotics.
6. Ongoing treatment with cortisone or other immunomodulatory drug.
7. Hypersensitivity to clobetasol propionate.
8. Severe periodontitis, as defined by Papapanou et al 2018 (4):
CAL > 5 mm, probing depth> 6 mm, furcation involvement 2 and 3.
9. Poor oral hygiene (plaque index [according to Silness-Löe]> 2).
10. Oral lichen planus not verified by biopsy.
11. Hypersensitivity to nystatin.
12. Not reached menopaus.
13. Ongoing or previosly intraoral malignancy.
14. Ongoing participation in another drug study. |
1. Lichenoida kontaktreaktioner.
2. Graft versus host disease.
3. Plack-associerad lichenoid reaktion.
4. Intraorala blåsbildande sjukdomar.
5. Pågående behandling med antibiotika.
6. Pågående behandling med kortison eller annat immunomodullerande
läkemedel.
7. Överkänslighet mot klobetasolpropionat.
8. Svår parodontit, definition enl Papapanou et al 2018:
Klinisk stödjevävnadsförlust > 5 mm, fickdjup > 6 mm,
furkationsinvolvering 2 och 3.
9. Uttalat dålig munhygien (plackindex [enl Silness-Löe] > 2).
10. Ej biopsiverifierad oral lichen planus.
11. Överkänslighet mot nystatin.
12. Ej uppnådd menopaus.
13. Pågående eller tidigare intraoral malignitet.
14. Pågående deltagande i annan läkemedelsstudie. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in lesion Activity score |
Förändring i lesionens Activity score |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of 4 weeks treatment. |
Efter 4 veckors behandling |
|
E.5.2 | Secondary end point(s) |
Change in OHIP-14
Change in Pain score
Change in Burning sensation score |
Förändring i OHIP-14
Förändring i Pain score
Förändring i Burning sensation score |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of 4 weeks treatment. |
Efter 4 veckors behandling |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 28 |