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A placebo-controlled double blind preliminary trial to study the efficacy and safety of Gelclair in controlling the symptoms of oral lichen planus

A placebo-controlled double blind preliminary trial to study the efficacy and safety of Gelclair in controlling the symptoms of oral lichen planus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60732049
Enrollment
60
Registered
2004-09-30
Start date
2004-01-15
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin and Connective Tissue Diseases: Oral lichen planus Skin and Connective Tissue Diseases Oral lichen planus

Interventions

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

Sponsors

Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 30 patients in control (placebo) group, 30 in Gelclair. Matched by symptoms and extent of disease at initial presentation.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Tolerability and acceptability

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026