An interventional study of Hyaluronic acid and Hyaluronic acid in Lip Augmentation, sponsored by Galderma R&D. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hyaluronic acid
Device: Hyaluronic acid
Hyaluronic acid
Device: Hyaluronic acid
Injectable gel for lip augmentation
Also known as: Restylane Kysse
Injectable gel. Lip Augmentation and other wrinkles/folds
Also known as: Restylane Kysse with other Restylane products
Assess Treatment With Restylane Kysse Using GAIS
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
Time frame: 8 weeks after last treatment
| Milestone | Restylane Kysse | Restylane Kysse With Other HA |
|---|---|---|
| Started | 19 | 40 |
| Completed | 18 | 38 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
| Participants | Restylane Kysse | Restylane Kysse With Other HA |
|---|---|---|
| Assess Treatment With Restylane Kysse Using GAIS | 18 | 38 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Restylane Kysse | 0/19 (0%) | 0/19 (0%) | 10/19 (52.6%) |
| Restylane Kysse With Other HA | 0/40 (0%) | 0/40 (0%) | 25/40 (62.5%) |
| Event | Restylane Kysse | Restylane Kysse With Other HA |
|---|---|---|
| Implant Site BruisingGeneral disorders | 6/19 | 17/40 |
| Implant Site OedemaGeneral disorders | 7/19 | 9/40 |
| Implant Site PainGeneral disorders | 6/19 | 14/40 |
| Impalnt site erythemaGeneral disorders | 3/19 | 10/40 |
| Implant Site SwellingGeneral disorders | 1/19 | 3/40 |
| ErythemaSkin and subcutaneous tissue disorders | 1/19 | 0/40 |
| Implant Site ReactionGeneral disorders | 0/19 | 1/40 |
| Implant Site DysaesthesiaGeneral disorders | 0/19 | 1/40 |
| GastroenteritisInfections and infestations | 0/19 | 1/40 |
| Gastroenteritis viralInfections and infestations | 0/19 | 1/40 |
| Age, Categorical(Participants) | Restylane Kysse | Restylane Kysse With Other HA | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 38 | 56 |
| >=65 years | 1 | 2 | 3 |
| Age, Continuous(years) | Restylane Kysse | Restylane Kysse With Other HA | Total |
|---|---|---|---|
| Mean | 36.1 ± 13.26 | 50.9 ± 10.53 | 46.2 ± 13.34 |
| Sex: Female, Male(Participants) | Restylane Kysse | Restylane Kysse With Other HA | Total |
|---|---|---|---|
| Female | 18 | 38 | 56 |
| Male | 1 | 2 | 3 |
| Race/Ethnicity, Customized(Participants) | Restylane Kysse | Restylane Kysse With Other HA | Total |
|---|---|---|---|
| Race — Asian | 1 | 1 | 2 |
| Race — White | 17 | 36 | 53 |
| Race — Other | 1 | 3 | 4 |
| Region of Enrollment(participants) | Restylane Kysse | Restylane Kysse With Other HA | Total |
|---|---|---|---|
| Canada | 19 | 40 | 59 |
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Plan to share: No
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Galderma R&D