A placebo-controlled double blind preliminary trial to study the efficacy and safety of Gelclair in controlling the symptoms of oral lichen planus
| ISRCTN | ISRCTN60732049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60732049 |
| Protocol serial number | N0013137372 |
| Sponsor | Department of Health |
| Funder | Guy's and St Thomas' NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 11/08/2016
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Penelope Shirlaw
Scientific
Scientific
Oral Medicine Department
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 4399 |
|---|---|
| pepe.shirlaw@gstt.sthames.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Gelclair |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
Tolerability and acceptability |
| Completion date | 15/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | 30 patients in control (placebo) group, 30 in Gelclair. Matched by symptoms and extent of disease at initial presentation. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/01/2004 |
| Date of final enrolment | 15/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oral Medicine Department
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/08/21016: No publications found in PubMed, verifying study status with principal investigator.
