Condition category
Skin and Connective Tissue Diseases
Date applied
04/11/2015
Date assigned
08/12/2015
Last edited
16/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

16/05/2016: Ethics approval information added.