Non-Cochrane · intervention · PM41758991
Topical Imiquimod for Oral Cavity Leukoplakia and Dysplasia: A Scoping Review.
Scharner Megan K, Walker Angelica M, Nguyen Shaun A, et al. · Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026 · PubMed · doi:10.1002/ohn.70107
Findings
Population Patients with oral cavity leukoplakia or dysplasia
8 findings
| Topical 5% imiquimod | None (single-arm; no comparator) | Buccal mucosa lesion location (lesion characteristic) Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) · Lesion location | Pooled proportion (%) 25.6 [2.0, 87.0] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm) | Incomplete lesion resolution Not specified | Pooled proportion (%) 42.3 [31.2, 54.0] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm; no comparator) | Never tobacco use (patient characteristic) Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) · Tobacco use | Pooled proportion (%) 50.7 [38.4, 63.0] GRADE not reported 3 studies · 82 participants |
| Topical 5% imiquimod | None (single-arm) | Complete lesion resolution Not specified | Pooled proportion (%) 37.0 [26.9, 48.4] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm; no comparator) | Tongue lesion location (lesion characteristic) Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) · Lesion location | Pooled proportion (%) 8.9 [3.7, 17.6] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm; no comparator) | Gingiva lesion location (lesion characteristic) Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) · Lesion location | Pooled proportion (%) 63.8 [24.1, 94.7] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm; no comparator) | Imiquimod application frequency of 5 days per week (treatment characteristic) Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) · Application frequency | Pooled proportion (%) 97.9 [91.1, 99.9] GRADE not reported 3 studies · 91 participants |
| Topical 5% imiquimod | None (single-arm; no comparator) | No response to treatment Post-treatment (regimens mostly 6 weeks; follow-up not consistently reported) | Pooled proportion (%) 23.4 [15.8, 33.4] GRADE not reported 3 studies · 91 participants |
Included primary studies 9
Open in Studies| Study | Year | Also included by | Outcomes it informs here | Trial data |
|---|---|---|---|---|
| Alhadlaq 2023 Novel Management Approach to Oral Leukoplakia: Topical Imiquimod Treatment DOI:10.1016/j.oooo.2023.07.022 | 2023 | this review only | not stated | not extracted yet |
| Allam 2008 Successful treatment of extensive human papillomavirus-associated oral leucoplakia with imiquimod. PMID:18076703 | 2008 | this review only | not stated | not extracted yet |
| Mane 2021 matched by author and year (probable) | NR | this review only | not stated | not extracted yet |
| Martinez-Lopez 2017 Successful treatment of proliferative verrucous leukoplakia with 5% topical imiquimod. PMID:27647537 | 2017 | this review only | not stated | not extracted yet |
| McDonald 2010 Treatment of actinic cheilitis with imiquimod 5% and a retractor on the lower lip: clinical and histological outcomes in 5 patients. PMID:19836865 | 2010 | this review only | not stated | not extracted yet |
| Mullins 2016 Treatment of oral dysplasia with 5% imiquimod cream: short communication. PMID:27178528 | 2016 | this review only | not stated | not extracted yet |
| Ozbagcivan 2020 Oral leukoplakia: Failure of topical imiquimod 5% DOI:10.4274/turkderm.galenos.2019.00187 | 2020 | this review only | not stated | not extracted yet |
| Sroussi 2025 Imiquimod for the treatment of oral leukoplakia: A two-center retrospective study. PMID:39007165 | 2025 | this review only | not stated | not extracted yet |
| Townsend 2024 Eradication of proliferative verrucous leukoplakia with toll-like receptor 7 agonist (topical imiquimod): a case report. PMID:39619444 | 2024 | this review only | not stated | not extracted yet |
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Oral cavity leukoplakia or dysplasia, human subjects | 89 patients with 99 oral cavity leukoplakia or dysplasia lesions (mean age 48.4 years) |
| Intervention | Topical imiquimod | 5% topical imiquimod, mostly 6 weeks (n=9 studies) |
| Comparison | Not specified | None (single-arm) |
| Outcomes | Lesion resolution or change in lesion size; adverse events | Complete, incomplete and no lesion response; adverse events |
| Study designs | All designs including case reports and case series | 1 pilot RCT, 2 cohort studies, 1 case series, 5 case reports (n=9) |
| Timing | Not specified | Treatment 6 weeks to 6 months |
AMSTAR 2 items
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | Yes | Yes | yes |
| 4Comprehensive literature searchcritical | No | No | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | Yes | Yes | yes |
| 8Included studies described in detail | Partial Yes | Partial Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: No · NRSI: No | NRSI: Partial Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: N/A · NRSI: No | NRSI: No · RCT: No | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | Yes | Yes | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |