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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P170002 S030/ PAS001 |
| Date Original Protocol Accepted |
02/29/2024
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| Date Current Protocol Accepted |
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| Study Name |
Teoxane Lip Fullness Scale (TLFS) PAS
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| Device Name |
RHA®3 dermal filler
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The PAS consists of 2 non-interventional studies, i.e. a photographic and a live validation of the 5-grade photonumeric TLFS scale. The objective of this protocol is to guide the photographic and the live validations of the 5-grade TLFS to be used as a validated instrument for the assessment of the lip fullness.
The scale validation will allow for verification of the repeatability and reproducibility of the scale.
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| Study Population |
At least 200 individual subjects will be photographed by a qualified photographic image services vendor (Canfield Scientific) to collect a subset of subject’s representative of full ranges of lip fullness with a broad diversity of age, gender, ethnicity/race and Fitzpatrick skin phototype, in order to create a pool of appropriate participants for photographic assessment, live assessment, or both.
For the live Validation, a minimum of 80 and a maximum of 150 subjects will be selected to participate to the 2 sessions of the live validation (2 weeks apart). Subjects will be selected by one member of the Scale Working Group from the pre-screened subjects. They will be selected to be approximately equally distributed between the 5 grades of the TLFS. However, the live subjects will not be assigned a true grade. The selected subjects will include Fitzpatrick Skin type from I to VI.
Subjects may participate in both photographic and live scale validations.
In addition, two other sets of different photographs will be selected from the photo collection: one Training Set and one Certification Set. These 2 Sets will include different photographs from each other, and different from the Validation Set (used for the Photographic Scale Validation). The Training Set will be used for training the scale validators (members of both Photographic and Live Scale Validation Groups) and future raters. The Training Set will include at least 3 photographs for each grade, as well as the full range of Fitzpatrick skin types.
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| Sample Size |
Number of subjects: 200-350 (200 photograph + 80-150 live, but subjects may participate in both)
Assumptions for sample size estimation: Not provided
Number of sites: Not provided
Sites location: Not provided
-Distribution across each point/grade on the scale. There will be an approximative balance distribution between each grade, i.e., there will be approximately the same number of photographs for each of the 5 grades.
-Demographic:
At least 20% of subjects with Fitspatrick Skin Type (FST) IV-VI
At least 10% of subjects with FST V/VI including subjects with FST V and FST VI
At least 10% of subjects of Hispanic ethnicity
At least 3% of subjects of Asian descent
Of note: there are no FDA specific requirements for stratification by grade and by FST, and by ethnicity in this validation protocol.
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| Key Study Endpoints |
To demonstrate the photographic validity (i.e. repeatability and reproducibility) of the scale.
To demonstrate the live validity (i.e., repeatability and reproducibility) of the scale.
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