Contact information
Type
Scientific
Primary contact
Ms Penelope Shirlaw
ORCID ID
Contact details
Oral Medicine Department
22nd Floor
Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4399
pepe.shirlaw@gstt.sthames.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013137372
Study information
Scientific title
A placebo-controlled double blind preliminary trial to study the efficacy and safety of Gelclair in controlling the symptoms of oral lichen planus
Acronym
Study hypothesis
To compare the symptom control offered by Gelclair vs placebo in patients with symptomatic oral lichen planus. Gelclair will be a useful adjunct in the management of pain associated with oral lichen planus.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Skin and Connective Tissue Diseases: Oral lichen planus
Intervention
Patients presenting to the department of oral medicine will be assessed for their suitability for inclusion within the trial. They will be invited to take part if they are diagnosed with lichen planus not due to a specific cause and confirmed histologically. They will be paired according to their symptoms at the time of presentation and randomised to either Gelclair or placebo. Normal treatment for lichen planus in the form of topical steroids will be prescribed as normal.
Intervention type
Drug
Phase
Not Specified
Drug names
Gelclair
Primary outcome measure
Gelclair is of use in managing the symptoms of pain in oral lichen planus. Primary response criteria: symptom control over an eight-week period, usage of topical corticosteroids (patient-controlled).
Secondary outcome measures
Tolerability and acceptability
Overall trial start date
15/01/2004
Overall trial end date
15/06/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
30 patients in control (placebo) group, 30 in Gelclair. Matched by symptoms and extent of disease at initial presentation.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
15/01/2004
Recruitment end date
15/06/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oral Medicine Department
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Guy's and St Thomas' NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list