Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
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ClinicalTrials.gov Identifier: NCT01192204 |
Recruitment Status :
Completed
First Posted : August 31, 2010
Results First Posted : August 14, 2015
Last Update Posted : August 14, 2015
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Conditions |
Squamous Cell Carcinoma of Mouth Intraepithelial Neoplasia |
Interventions |
Drug: 10% FBR containing bioadhesive gel Drug: placebo gel |
Enrollment | 41 |
Recruitment Details | |
Pre-assignment Details | 41 patients were enrolled in this protocol. 1 patient could not keep the appointments and was referred to his private oral surgeon. |
Arm/Group Title | 10% FBR Gel | Placebo Gel |
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Active 10% FBR containing bioadhesive gel Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months |
Color/consistency matched placebo (no black raspberry) gel Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months |
Period Title: Overall Study | ||
Started | 23 | 18 |
Completed | 22 | 18 |
Not Completed | 1 | 0 |
Reason Not Completed | ||
could not keep recall appointments | 1 | 0 |
Arm/Group Title | 10% FBR Gel | Placebo Gel | Total | |
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Active 10% FBR containing bioadhesive gel Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months |
Color/consistency matched placebo (no black raspberry) gel Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months |
Total of all reporting groups | |
Overall Number of Baseline Participants | 23 | 18 | 41 | |
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[Not Specified]
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Age, Categorical
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 18 participants | 41 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
17 73.9%
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5 27.8%
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22 53.7%
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>=65 years |
6 26.1%
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13 72.2%
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19 46.3%
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[1]
Measure Description: The patients were randomly assigned by computer generated numbers to either the BRB or the placebo gel groups.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 23 participants | 18 participants | 41 participants | |
62.2 (1.8) | 57.7 (2.9) | 59.9 (2.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | 18 participants | 41 participants | |
Female |
14 60.9%
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9 50.0%
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23 56.1%
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Male |
9 39.1%
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9 50.0%
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18 43.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 23 participants | 18 participants | 41 participants |
23 | 18 | 41 |
Name/Title: | Susan R, Mallery DDS, PhD |
Organization: | The Ohio State University |
Phone: | 614 292-5892 |
EMail: | mallery.1@osu.edu |
Responsible Party: | Susan Mallery DDS, PhD, Ohio State University |
ClinicalTrials.gov Identifier: | NCT01192204 |
Other Study ID Numbers: |
2009C0086 RC2CA148099 ( U.S. NIH Grant/Contract ) |
First Submitted: | August 30, 2010 |
First Posted: | August 31, 2010 |
Results First Submitted: | April 29, 2015 |
Results First Posted: | August 14, 2015 |
Last Update Posted: | August 14, 2015 |