Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paolo Giacomo Arduino
ORCID ID
http://orcid.org/0000-0002-8798-7834
Contact details
Via Nizza 230
Turin
10100
Italy
+39 (0)1633 1522
paologiacomo.arduino@unito.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus: a randomized controlled trial
Acronym
OLP_clobvsplac
Study hypothesis
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
CIR - Dental School, 04/04/016, Ref: CIR-Dental School - DRPGA -0026-2016
Study design
Interventional single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase II/III
Drug names
Clobetasol
Primary outcome measures
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 trial start date
01/01/2015
Overall trial end date
01/06/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/01/2016
Recruitment end date
01/12/2016
Locations
Countries of recruitment
Italy
Trial participating centre
CIR - Dental School, University of Turin
Via Nizza 230
Turin
10100
Italy
Sponsor information
Organisation
University of Turin (Italy)
Sponsor details
Via Nizza 230
Turin
10100
Italy
+39 (0)116 331 522
roberto.broccoletti@unito.it
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Turin (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
01/08/2016
Participant level data
Available on request
Results - basic reporting
Publication summary
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29297958