Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects

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Galderma

Status

Active, not recruiting

Conditions

Lip Augmentation

Treatments

Device: Restylane Kysse

Study type

Interventional

Funder types

Industry

Identifiers

NCT05342753
05DF2007

Details and patient eligibility

About

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.

Enrollment

50 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent
  • Ability to adequately understand the verbal explanations and the written subject information provided in English
  • Subjects seeking augmentation therapy for the lips
  • Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
  • Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
  • Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
  • Previous facial surgery, within 6 months, below the level of the lower orbital rim
  • Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
  • Participation in any interventional clinical study within 30 days of screening

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Restylane Kysse
Experimental group
Description:
Hyaluronic Acid
Treatment:
Device: Restylane Kysse

Trial contacts and locations

4

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Central trial contact

Clinical Project Manager

Data sourced from clinicaltrials.gov

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