Trial Outcomes & Findings for Using MASL to Combat Oral Cancer (NCT NCT04188665)
NCT ID: NCT04188665
Last Updated: 2026-03-20
Results Overview
Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression.
COMPLETED
EARLY_PHASE1
18 participants
1 day.
2026-03-20
Participant Flow
18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
18 subjects were consented and enrolled for consideration in this study. Of these, 8 subjects went on to the treatment phase of the study. Four of these 8 subjects were treated with MASL (experimental group) and four were treated with placebo (control group). The other 10 consented subjects were not considered for either MASL or placebo treatment, but their biological samples were still analyzed in the course of this study.
Participant milestones
| Measure |
MASL Treated
Patients treated with lozenge containing MASL
MASL: Patients treated with MASL lozenge
|
Placebo Treated
Patients treated with lozenge without MASL
Placebo: Patients treated with placebo lozenge
|
Nontreated
Enrolled subject not treated with MASL or placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
10
|
|
Overall Study
COMPLETED
|
4
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MASL Treated
n=4 Participants
Patients treated with lozenge containing MASL
MASL: Patients treated with MASL lozenge
|
Placebo Treated
n=4 Participants
Patients treated with lozenge without MASL
Placebo: Patients treated with placebo lozenge
|
Nontreated
n=10 Participants
Patients not treated with MASL or placebo
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=18 Participants
|
|
Age, Continuous
|
57.25 years
n=4 Participants
|
49.5 years
n=4 Participants
|
62.6 years
n=10 Participants
|
53.4 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=10 Participants
|
13 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
10 participants
n=10 Participants
|
8 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 1 day.Measure morphology and podoplanin (PDPN) expression by immunohistochemistry of cells included in initial biopsies of oral lesions in comparison to normal oral squamous epithelial cells (OSCCs). We selected patients with lesions that express robust levels of PDPN and notable dysplasia for inclusion in the study. Intensity was graded on a scale of 1 to 5 with 5 having the most dysplastic morphology and highest PDPN expression.
Outcome measures
| Measure |
MASL Treated
n=4 Participants
Patients treated with lozenge containing MASL
MASL: Patients treated with MASL lozenge
|
Placebo Treated
n=4 Participants
Patients treated with lozenge without MASL
Placebo: Patients treated with placebo lozenge
|
Nontreated
n=10 Participants
Subjects not treated with MASL or placebo
|
|---|---|---|---|
|
Pre-treatment OSCC Morphology and PDPN Expression
|
2.8 score on a scale from 1 to 5
Standard Error .37
|
3.4 score on a scale from 1 to 5
Standard Error .26
|
2.5 score on a scale from 1 to 5
Standard Error .16
|
SECONDARY outcome
Timeframe: 1 dayEvaluate and compare the PDPN expression and morphology of cells from included in resected oral lesions from patients treated with the experimental compound MASL or placebo. We will measure if MASL treatment decreases PDPN expression and normalizes morphology of OSCC cells on a defined scale of pathological examination by immunohistochemistry.
Outcome measures
| Measure |
MASL Treated
n=4 Participants
Patients treated with lozenge containing MASL
MASL: Patients treated with MASL lozenge
|
Placebo Treated
n=4 Participants
Patients treated with lozenge without MASL
Placebo: Patients treated with placebo lozenge
|
Nontreated
n=10 Participants
Subjects not treated with MASL or placebo
|
|---|---|---|---|
|
Post-treatment OSCC Morphology and PDPN Expression
|
4.1 score on a scale from 1 to 5
Standard Error .38
|
4.6 score on a scale from 1 to 5
Standard Error .22
|
3.7 score on a scale from 1 to 5
Standard Error .35
|
Adverse Events
MASL Treated
Placebo Treated
Nontreated
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place