Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus
| ISRCTN | ISRCTN10647973 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10647973 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/11/2015
- Registration date
- 08/12/2015
- Last edited
- 18/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims:
Oral lichen planus (OLP) is a non-infectious, itchy rash that affects the mouth. To date, the most commonly employed and useful treatment for OLP is topical corticosteroids. The aim of this study is to assess the effectiveness of the corticosteroid clobetasol ointment, compared with a placebo (dummy) gel, for the treatment of OLP.
Who can participate?
Patients over 18 years old with OLP.
What does the study involve?
The study is divided into two phases: phase I consisted of topical treatment for 2 months; phase II was a six-month follow-up period without therapy. Patients are randomly divided into two groups. One group receives clobetasol ointment mixed with a gel, while the second group receives only the gel. The participants are treated for 2 months and followed up 6 months later.
What are the possible benefits and risks of participating?
Topical steroids are an effective and safe treatment for OLP patients. Possible local minor side effects could be expected but they will disappear immediately after stopping treatment.
Where is the study run from?
CIR – Dental School, Turin, Italy
When is the study starting and how long is it expected to run for?
September 2015 to September 2016
Who is funding the study?
University of Turin (Italy)
Who is the main contact?
Dr Paolo G Arduino
paologiacomo.arduino@unito.it
Contact information
Scientific
Via Nizza 230
Turin
10100
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | +39 (0)1633 1522 |
| paologiacomo.arduino@unito.it |
Study information
| Study design | Interventional single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus: a randomized controlled trial |
| Study acronym | OLP_clobvsplac |
| Study objectives | Oral lichen planus (OLP) is a chronic inflammatory disease that can be painful, mainly in the atrophic and erosive forms. Numerous drugs have been used with dissimilar results, but most treatments are empirical and do not have adequate control groups or correct study designs. To date, the most commonly employed and useful agents for the treatment of LP are topical corticosteroids, but no data are available if compared with placebo treatment. The aim of this study is to assess the efficacy of topical clobetasol 0.05%, compared with 4% hydroxyethyl cellulose bioadhesive gel, for the treatment of erosive oral lichen planus. |
| Ethics approval(s) | CIR - Dental School, 04/04/016, Ref: CIR-Dental School - DRPGA -0026-2016 |
| Health condition(s) or problem(s) studied | Oral lichen planus |
| Intervention | The study is divided into two phases: phase I consisted of topical treatment for 2 months; phase II was a six-month follow-up period without therapy. Patients are randomly divided into two groups. Randomization is performed using computer-generated random number tables. The first group of patients received clobetasol 0.05% ointment mixed with a hydroxyethyl cellulose adhesive gel, whereas the second group of patients received only 4% hydroxyethyl cellulose bioadhesive gel. The medication are distributed in identical containers, packed by someone who was unaware of the study. The coded tubes were consecutively numbered according to the randomization list which was prepared and retained by a single clinician (R.B.). During treatment, neither the physicians nor the patients knew which of the two medications they were using. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Clobetasol |
| Primary outcome measure | Pain (visual analogue scale [VAS]) and clinical scores (Thongpranson scale) assessed at baseline, 4 weeks, 8 weeks, 20 weeks and 32 weeks |
| Secondary outcome measures | 1. Time taken to reduce signs and symptoms during the first two weeks of treatment 2. Length of remission from signs and symptoms |
| Overall study start date | 01/01/2015 |
| Completion date | 01/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Histological diagnosis of OLP on the basis of WHO criteria: hyperkeratosis of the superficial epithelial layers, vacuolar degeneration of the germinative layer of the epithelium and band-like sub-epithelial lymphocytic inflammatory infiltrate 2. Presence of painful and atrophic-erosive oral lesions, at the same time with reticular ones 3. Ability to complete the present trial |
| Key exclusion criteria | 1. Presence of histological signs of dysplasia 2. Use of lichenoid reaction inducing drugs and presence of amalgam fillings close to lesions 3. Therapy for OLP in the 2 months prior to the study 4. Pregnant or breastfeeding women 5. Proved or suspected hypersensitivity caused by the tested chemicals |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
Turin
10100
Italy
Sponsor information
University/education
Via Nizza 230
Turin
10100
Italy
| Phone | +39 (0)116 331 522 |
|---|---|
| roberto.broccoletti@unito.it | |
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/08/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2018 | Yes | No |
Editorial Notes
18/04/2018: Publication reference added.
16/05/2016: Ethics approval information added.
