Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/21016: No publications found in PubMed, verifying study status with principal investigator.