Phase 2
N=25
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT01066026 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Haematoma — 10; 23; 6; 11 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- hyaluronic acid with metallic cannula or standard needle. (Procedure); Hyaluronic acid injected with the new tool. (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hexsel Dermatology Clinic
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Haematoma |
10; 23; 6; 11; 1; 4 | <0.0001 sig |
| PRIMARY Number of Participants With Erythema |
22; 25; 0; 1; 0; 0 | — |
| SECONDARY Modified Fitzpatrick Wrinkle Scale (MFWS) |
2.40; 2.40; 1.57; 1.54 | — |
| SECONDARY Global Aesthetic Improvement Scale |
2; 2 | — |
Summary
The purpose of this study was to assess the safety and efficacy of a new metallic cannula to inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard needle.
Eligibility Criteria
Inclusion Criteria
- Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
- Female subjects aged from 18 to 60
- Fitzpatrick phototype I to VI
- Presence of bilateral folds graded from 2 to 3 according to the Modified
- Fitzpatrick Wrinkle Scale
- Subjects that have never performed any treatment of nasolabial folds
- Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method
- Subjects who will be available throughout the duration of the study
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.
Exclusion Criteria
- Use of systemic corticosteroids
- History of herpes in lip
- Inflammation or active infection in the area to be injected
- Any surgical treatment or cosmetic procedure in the area to be injected that interfere in study's outcomes
- Coagulation disorders or use of anticoagulants
- Previous hypersensitivity responses to Hyaluronic acid.
- Pregnant or women in breastfeeding, or women planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT01066026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.