Study to Evaluate Satisfaction After Treatment With Kysse

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03967444
• Collaborator: (none)
• Enrollment: 59
• Locations: 2
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site: 29.5
• Patients Per Site Per Month: 8

Study Details

Study Description

Brief Summary

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.

Condition or Disease	Intervention/Treatment	Phase
Lip Augmentation	Device: Hyaluronic acid; Device: Hyaluronic acid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse
• Actual Study Start Date: May 29, 2019
• Actual Primary Completion Date: Sep 18, 2019
• Actual Study Completion Date: Sep 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Restylane Kysse Hyaluronic acid	Device: Hyaluronic acid; Injectable gel for lip augmentation; Other Names: Restylane Kysse
Other: Restylane Kysse with other HA Hyaluronic acid	Device: Hyaluronic acid; Injectable gel. Lip Augmentation and other wrinkles/folds; Other Names: Restylane Kysse with other Restylane products

Outcome Measures

Primary Outcome Measures

1. Assess Treatment With Restylane Kysse Using GAIS [8 weeks after last treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Signed and dated informed consent to participate in the study

• Adult women and men who intend to undergo lip augmentation

Exclusion Criteria:

• Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics

• Subjects with a previous implant other than HA in or near the intended treatment site

• Participation in any other clinical study within three (3) months before treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma Study Site	Montréal		Canada
2	Galderma Study Site	Toronto		Canada

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Study Director, Galderma R&D

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 25, 2018
• Study Protocol - Mar 25, 2019

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT03967444
• Other Study ID Numbers: 05DF1807
• First Posted: May 30, 2019
• Last Update Posted: Mar 1, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Restylane Kysse	Restylane Kysse With Other HA
Arm/Group Description	Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation	Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
Period Title: Overall Study
STARTED	19	40
COMPLETED	18	38
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Restylane Kysse	Restylane Kysse With Other HA	Total
Arm/Group Description	Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation	Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds	Total of all reporting groups
Overall Participants	19	40	59
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 94.7%	38 95%	56 94.9%
>=65 years	1 5.3%	2 5%	3 5.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.1 (13.26)	50.9 (10.53)	46.2 (13.34)
Sex: Female, Male (Count of Participants)
Female	18 94.7%	38 95%	56 94.9%
Male	1 5.3%	2 5%	3 5.1%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 5.3%	1 2.5%	2 3.4%
White	17 89.5%	36 90%	53 89.8%
Other	1 5.3%	3 7.5%	4 6.8%
Region of Enrollment (participants) [Number]
Canada	19 100%	40 100%	59 100%

Outcome Measures

1. Primary Outcome

Title	Assess Treatment With Restylane Kysse Using GAIS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Restylane Kysse	Restylane Kysse With Other HA
Arm/Group Description	Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation	Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
Measure Participants	18	38
Count of Participants [Participants]	18 94.7%	38 95%

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Restylane Kysse		Restylane Kysse With Other HA
Arm/Group Description	Hyaluronic acid Hyaluronic acid: Injectable gel for lip augmentation		Hyaluronic acid Hyaluronic acid: Injectable gel. Lip Augmentation and other wrinkles/folds
All Cause Mortality
	Restylane Kysse		Restylane Kysse With Other HA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/40 (0%)
Serious Adverse Events
	Restylane Kysse		Restylane Kysse With Other HA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Restylane Kysse		Restylane Kysse With Other HA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/19 (52.6%)		25/40 (62.5%)
Ear and labyrinth disorders
Tympanic membrane perforation	0/19 (0%)	0	1/40 (2.5%)	1
General disorders
Implant Site Bruising	6/19 (31.6%)	8	17/40 (42.5%)	31
Implant Site Pain	6/19 (31.6%)	12	14/40 (35%)	41
Implant Site Oedema	7/19 (36.8%)	15	9/40 (22.5%)	23
Impalnt site erythema	3/19 (15.8%)	5	10/40 (25%)	21
Implant Site Swelling	1/19 (5.3%)	1	3/40 (7.5%)	3
Implant Site Reaction	0/19 (0%)	0	1/40 (2.5%)	1
Implant Site Dysaesthesia	0/19 (0%)	0	1/40 (2.5%)	1
Infections and infestations
Gastroenteritis	0/19 (0%)	0	1/40 (2.5%)	1
Gastroenteritis viral	0/19 (0%)	0	1/40 (2.5%)	1
Pharyngitis streptococcal	0/19 (0%)	0	1/40 (2.5%)	1
Varicella zoster virus infection	0/19 (0%)	0	1/40 (2.5%)	1
Injury, poisoning and procedural complications
Animal Scratch	0/19 (0%)	0	1/40 (2.5%)	1
Skin and subcutaneous tissue disorders
Erythema	1/19 (5.3%)	1	0/40 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.