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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250016 / PAS001 |
| Date Original Protocol Accepted |
08/31/2026
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| Date Current Protocol Accepted |
08/31/2026
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| Study Name |
Belotero Intense PAS
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| Device Name |
Belotero® Intense (+) Lidocaine
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| Clinical Trial Number(s) |
NCT05773066
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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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: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
A Prospective, Post-Market, Open-Label, Multicenter, Single-Arm Study Evaluating the Safety and Effectiveness of Belotero® Intense (+) Lidocaine for Lip Augmentation in Participants with Fitzpatrick Skin Types V or VI
Primary objective
-Demonstrate safety of BIL for use in lip augmentation in participants with Fitzpatrick Skin Type (FST) V or VI
Secondary objective
-Demonstrate the effectiveness of BIL for lip augmentation in participants with FST V or VI
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| Study Population |
Approximately 20 healthy male, female, or transgender participants will be screened to achieve approximately 16 participants for BIL treatment.
Enrollment is planned across approximately three US investigational sites.
Participants are expected to be healthy FST V or VI male, female, or transgender over 21 years and less than or equal to 65 years of age at the time of signing the informed consent and desiring lip augmentation to correct volume deficit with upper and/or lower lip deficit rating of 0 (very thin), 1 (thin), or 2 (medium) on the Merz Lip Fullness Assessment Scale (MLFAS), as determined by the treating investigator.
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| Sample Size |
Number of subjects: 20
Assumptions for sample size estimation: n/a
Number of sites: 3
Sites location: United States
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| Key Study Endpoints |
Safety Endpoints
Primary: Occurrence of related TEAEs, as documented by the investigator throughout the study
Secondary:
-Occurrence of TEAEs
-Occurrence of serious TEAEs
-Occurrence of TEAEs leading to discontinuation from the study
-Occurrence of device deficiencies
-Occurrence of prespecified CTRs as documented by the participant for 28 days after each treatment
-Normal and abnormal results of active lip function and sensation assessments (Section 11.2.7). Abnormality is defined as a difference between pre- and post-treatment assessments.
-Normal and abnormal results in the post-treatment lip function and sensation questionnaire (Section 11.2.7.3). Abnormality is defined as a score of greater than or equal to 4 for any item in the participant-assessed function and sensation questionnaires.
-Normal and abnormal results of lip symmetry and lip movement assessments (Section 11.2.8).
-Normal and abnormal results of the visual acuity test using the Snellen chart
-Normal and abnormal results of the confrontation visual field test
-Normal and abnormal results of the ocular motility examination
-Normal and abnormal results of Facial drooping, Arm weakness, Speech difficulties, Time to call emergency services (FAST) test
Effectiveness Endpoints
Secondary: Responder rate at Visit V3, according to the MLFAS, as assessed live by the treating investigator, where response is defined as greater than or equal to 1-point improvement on participant’s treated lip(s) compared to baseline
Tertiary:
- Global Aesthetic Improvement Scale (GAIS) scores for treated participants at all post-baseline visits, as completed by the treating investigator (iGAIS)
- GAIS scores for treated participants at all post-baseline visits, as completed by the participant (pGAIS)
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| Follow-up Visits and Length of Follow-up |
The expected study duration per participant, excluding visit windows, is up to 30 weeks (up to 10 days screening period + baseline treatment + optional touch-up at Week 4 + 24-week follow-up).
Participants without a touch-up will have seven onsite visits (including screening), and participants with a touch-up will have nine onsite visits (including screening). After the baseline visit, follow-up visits will occur at Weeks 2, 4, 8, 16, and 24 for participants without touch-up and Weeks 2, 4, 6, 8, 16, 20, and 28, for participants with touch-up.
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