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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Paolo Giacomo Arduino
Scientific

Via Nizza 230
Turin
10100
Italy

ORCiD logoORCID ID 0000-0002-8798-7834
Phone +39 (0)1633 1522
Email paologiacomo.arduino@unito.it

Study information

Study designInterventional single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleClobetasol propionate 0.05% versus placebo for the management of erosive oral lichen planus: a randomized controlled trial
Study acronymOLP_clobvsplac
Study objectivesOral 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) studiedOral lichen planus
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II/III
Drug / device / biological / vaccine name(s)Clobetasol
Primary outcome measurePain (visual analogue scale [VAS]) and clinical scores (Thongpranson scale) assessed at baseline, 4 weeks, 8 weeks, 20 weeks and 32 weeks
Secondary outcome measures1. 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 date01/01/2015
Completion date01/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2016
Date of final enrolment01/12/2016

Locations

Countries of recruitment

  • Italy

Study participating centre

CIR - Dental School, University of Turin
Via Nizza 230
Turin
10100
Italy

Sponsor information

University of Turin (Italy)
University/education

Via Nizza 230
Turin
10100
Italy

Phone +39 (0)116 331 522
Email roberto.broccoletti@unito.it
ROR logo "ROR" https://ror.org/048tbm396

Funders

Funder type

University/education

University of Turin (Italy)

No information available

Results and Publications

Intention to publish date01/08/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo 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.