An interventional study of Restylane and Perlane in Healthy Volunteers, sponsored by Galderma R&D. Completed at 2 sites in Taiwan. Open to female participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population.
Galderma R&D is the lead sponsor of 283 studies on the registry; 10 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Restylane and/or Perlane
Device: Restylane · Device: Perlane
Facial tissue augmentation
Facial tissue augmentation
Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
Time frame: 6 Months
Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds". A participant is considered improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek". A participant is assessed as improved if she scores at least one grade improvement from baseline.
Time frame: 6 and 12 Months after first and second treatment, respectively
| Milestone | Intradermal Injection |
|---|---|
| Started | 100 |
| 6 months follow-up | 99 |
| 12 months follow-up | 98 |
| Completed | 98 |
| Not completed | 2 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Intradermal Injection |
|---|---|
| Started | 98 |
| 6 months follow-up | 97 |
| 12 months follow-up | 96 |
| Completed | 96 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment. The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse. A participant is considered "improved" if she answers Very much improved, Much improved, or Improved.
| percentage of participants | Intradermal Injection |
|---|---|
| Percentage of Participants Improved in "Global Facial Aesthetic Appearance" - Judged by Participant | 95 (89 to 98) |
The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is "No folds" and 4 is "Very severe folds". A participant is considered improved if she scores at least one grade improvement from baseline.
| percentage of participants | Right Nasolabial Fold | Left Nasolabial Fold |
|---|---|---|
| 6 Months after first treatment | 54 (43 to 65) | 65 (54 to 75) |
| 12 Months after first treatment | 47 (36 to 58) | 46 (35 to 57) |
| 6 Months after second treatment | 65 (54 to 75) | 62 (51 to 72) |
| 12 Months after second treatment | 54 (42 to 65) | 55 (44 to 66) |
The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is "Full upper cheek" and 4 is "Very severely sunken upper cheek". A participant is assessed as improved if she scores at least one grade improvement from baseline.
| percentage of participants | Right Upper Cheek | Left Upper Cheek |
|---|---|---|
| 6 Months after first treatment | 66 (55 to 75) | 67 (57 to 77) |
| 12 Months after first treatment | 38 (28 to 48) | 43 (33 to 54) |
| 6 Months after second treatment | 77 (68 to 85) | 78 (69 to 86) |
| 12 Months after second treatment | 69 (59 to 78) | 71 (60 to 79) |
Collected over 2 years, 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intradermal Injection | 0/100 (0%) | 5/100 (5%) | 34/100 (34%) |
| Event | Intradermal Injection |
|---|---|
| Chronic paranasal sinusitisInfections and infestations | 1/100 |
| Herpes simplex progenitalisInfections and infestations | 1/100 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 1/100 |
| Intraductal papilloma (benign)Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/100 |
| Left ovary tumor with endometrial polypsReproductive system and breast disorders | 1/100 |
| Event | Intradermal Injection |
|---|---|
| NasopharyngitisInfections and infestations | 18/100 |
| Upper respiratory tract infectionInfections and infestations | 10/100 |
| AcneSkin and subcutaneous tissue disorders | 6/100 |
| Implant site bruisingGeneral disorders | 6/100 |
| Implant site painGeneral disorders | 5/100 |
| Age, Continuous(years) | Intradermal Injection |
|---|---|
| Mean | 39.7 ± 5.4 |
| Sex: Female, Male(Participants) | Intradermal Injection |
|---|---|
| Female | 100 |
| Male | 0 |
| Region of Enrollment(participants) | Intradermal Injection |
|---|---|
| Taiwan | 100 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.