Table 1.

Cumulative clinical trial data

Smoking historyLesional size (mm2)HistopathologyLOH
#SexAgePk y (a)PVLPrevious biopsiesbPreTxPostTxPretreatmentPosttreatmentPreTxPostTxCumulative responsiveness (score)3-Month recurrence
ActiveA1F550NY (5)32.0719.68DYS (mild to moderate)DYS (mild)30High (5)Y
A2F620YY (2)59.8454.06ATYATY30Intermediate (3)N
A3F7426 (1991)YY (3)21.5423.27ATYATY11Non (0)Y
A4M690YY (4)NENEDYS (focally mild)DYS (mild)20Low (2)N
A5F650NY (6)8.876.80DYS (moderate to severe)DYS (moderate to severe)21Low (1)N
A6M565 (1980)NN58.180.00DYS (mild)Normal30High (8)LC
A7F550NY (4)6.780.00DYS (severe)DYS (mild to moderate)00High (6)Y
A8F6935 (1996)YY (3)30.6033.93DYS (mild)DYS (mild)10Low (1)Y
A9M6020 (1975)YY (1)74.8042.28ATYATY00Low (1)N
A10M665 (1968)NY (1)39.6443.07DYS (mild)DYS (mild)00Non (0)N
A11M470YN170.8772.56ATYATY00Low (2)N
A12F5925 (2010)YY (1)24.0710.88ATYATY00Low (2)N
A13F700YY (1)53.9849.71DYS (mild)ATY00Low (1)N
A14F610YY (1)63.33106.45DYS (mild)DYS (moderate)33Low (−4)N
A15F7320 (1989)YN279.24231.40DYS (mild)ATY11Low (1)N
A16F561.05 (1997)NN12.158.82DYS (mild)ATY00Low (2)N
A17M7020 (1996)NN227.70137.69ATYATY00Low (1)Y
A18F560YN23.8516.99DYS (mild to focally moderate)DYS (mild)10Intermediate (3)N
A19F770YY (1)53.2849.44ATYATY30Intermediate (3)Y
A20M595 (2006)NY (3)110.7154.60ATYORT10High (4)N
A21F440NY (1)63.3730.05DYS (moderate to focally severe)DYS (moderate)22Intermediate (3)N
A22F650NY (1)75.0677.99DYS (ulcerated severe)DYS (severe)41Intermediate (3)N
PlaceboP1M785 (1992)YY (4)25.5546.44DYS (mild to moderate)DYS (mild to moderate)23Non (−4)Y
P2M630NY (3)8.765.94DYS (moderate to severe)DYS (moderate to severe)11Low (1)Y
P3M600NY (1)50.4951.38DYS (mild to focally moderate)DYS (mild)00Low (1)Y
P4F590NY (1)38.4752.79ATYATY30Low (2)N
P5M410NN43.9847.11DYS (Mild)DYS (Moderate)10Non (−1)Y
P6F670NY (2)95.75123.65DYS (Mild to moderate)DYS (Focally mild)12Non (−1)Y
P7M585.71 (1999)NN9.8110.96DYS (Mild)DYS (Mild)00Non (0)LC
P8F327.5 (2011)YY (8)64.4378.80DYS (Mild)DYS (Mild)20Low (2)Y
P9F650NY (4)256.69308.77DYS (Mild to moderate)DYS (Mild)12Non (0)N
P10M460NN68.8541.72ATYATY10Low (2)N
P11M660.75 (1960)NY (1)NENEATYDYS (Moderate)22Non (−3)N
P12M6220 (1987)NY (1)28.7829.83DYS (Moderate to severe)DYS (Mild to moderate)00Low (2)N
P13F610NY (1)10.628.75DYS (Mild to moderate)DYS (Mild to moderate)10Low (1)N
P14F680NN77.8774.58DYS (Mild to focally moderate)DYS (Mild)10Low (2)N
P15F500NY (2)17.3935.18DYS (Severe)DYS (Moderate to severe)00Non (−2)Y
P16F520NY (1)47.5447.21DYS (Moderate)DYS (Moderate)32Low (1)N
P17F390NY (1)95.45123.13DYS (Mild)ATY00Non (0)N
P18M7115 (1994)YY (1)107.23167.23DYS (Mild)DYS (Mild)00Non (−2)N

Abbreviations: ATY, atypia; DYS, dysplasia; LC, lost contact; NE, not evaluable; ORT, orthokeratosis; Pk y, pack years; PVL, proliferative verrucous leukoplakia.

  • a(Year) patient quit smoking.

  • bPrevious biopsies for OIN at lesional treatment site (number of biopsies performed before the trial).