Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia

Sponsor
Cairo University
Study ID
NCT07387900
Phase
PHASE2
Status
Recruiting
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Conditions

  • Oral Leukoplakia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    10% oral gel and 500mg tablet
  • Placebo — DRUG
    Placebo Gel and 500mg Placebo tablet

Study Details

There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin. While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Topical and systemic metformin
  • Placebo Comparator: Topical and systemic Placebo

Primary Outcome Measure

Change in lesion size [ Time Frame: over 6 months ]

Central Contacts

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