Last updated: 11/03/2018 22:28:30
Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe
GSK study ID
203115
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Clinical Study To Determine The Oral and Dermal Tolerability of an Experimental Denture Wipe
Trial description: The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.
Primary purpose:
Device Feasibility
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or before 14 days of use
Timeframe: up to 14 days
Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or before 7 days of use
Timeframe: up to 7 days
Secondary outcomes:
Proportion of participants experiencing skin irritation scores of 2 or greater after 7 and 14 days of use
Timeframe: Day 7, Day 14
Number of Participants Responses for Consumer Acceptability Questionnaire Score
Timeframe: Day 7
Interventions:
Enrollment:
152
Primary completion date:
2016-31-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Denture Cleansers
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2016 to October 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
Yes
- Demonstrated understanding of the study procedures, restrictions and was willing to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the informed consent form.
- Understood and was willing, able and comply with all study procedures and restrictions.
- Women who were known to be pregnant or who were intending to become pregnant over the duration of the study.
- Women who were breast-feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrated understanding of the study procedures, restrictions and was willing to participate as evidenced by voluntary written informed consent and had received a signed and dated copy of the informed consent form.
- Understood and was willing, able and comply with all study procedures and restrictions.
- Participant was in good general and mental health with, in the opinion of the investigator or medically qualified designee – (a) no clinically significant and relevant abnormalities of medical or physical history; (b) absence of any condition that impacted on the participant’s safety or well-being or affected the individual’s ability to understand and follow study procedures.
- Denture Requirements, fully or partially edentulous: (a) Phase 1 eligible participants had a full upper denture and may Have a full or partial lower denture or no lower Denture; (b) Phase 2 eligible subjects will have at least one full or partial denture; (c) Dentures considered in good condition according to the investigator or dental examiner, with no damage according to assessment criteria; (d) Participants with a peanut particle migration rating greater than zero on the upper denture only for participants screened for food removal testing.
- Skin Phototype (Fitzpatrick), I to IV, according to the scale only skin phototypes I to IV are acceptable for inclusion in this study: Type I
- White; very fair; freckles; typical albino skin. Always burns, never tans, Type II -White; fair. Usually burns, tans with difficulty, Type III
- Beige; very common. Sometimes mild burn, gradually tans to a light brown, Type IV
- Beige with a brown tint; typical Mediterranean Caucasian skin. Rarely burns, tans with ease to a moderate brown, Type V
- Dark brown. Very rarely burns, tans very easily, Type VI Black
- Never burns, tans very easily, deeply pigmented.
Exclusion criteria:
- Women who were known to be pregnant or who were intending to become pregnant over the duration of the study.
- Women who were breast-feeding.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Known allergy to any nuts or peanuts. History of allergic reactions or intense feelings of discomfort to topically used products: cosmetics or drugs.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit, except for participants who were enrolled on GSKCH study 205915 who might enrolled onto this study 7 days after their completion of 205915. Previous participation in this study.
- Recent history (within the last one year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family.
- Denture adhesive users were excluded from this study.
- Participants with OST findings such as, stomatitis, open sores, lesions, redness or swelling were excluded.
- Other Conditions because of participants were excluded are as follows: History of swallowing or choking difficulties; participants unwilling to refrain from using their existing denture cleansing routine for the duration of the study; taking or have taken a bisphosphonate drug for treatment of osteoporosis; skin marks in the experimental area which may interfere with the evaluation of potential skin reactions; active skin diseases (local and/or disseminated) that may interfere with the study results; participants with immunodeficiencies, intense sunlight exposure or tanning session within 15 days before the baseline evaluation or during the study that has resulted in sunburn; body cosmetic and/or dermatological treatment until three weeks before screening or during the study; continual use of therapeutic, topical or systemic use of the following drugs: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs and corticosteroids within two weeks before the screening for chronic conditions; oral or topical treatment with vitamin A acid and/or its derivatives within one month before start of study; vaccination within three weeks before or during the study; participants with dermographism; any condition not previously mentioned that in the investigator’s opinion may impair the study evaluation.
Trial location(s)
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-31-10
Actual study completion date
2016-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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