A Post Market Evaluation After Treatment of Nasolabial Folds

NCT02179736 | Completed

• 1 other identifier: 05DF1312
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, non-comparative study to evaluate effectiveness and safety of Restylane in correction of nasolabial folds up to 12 months after the initial treatment, and to evaluate the safety of repeat treatment of the nasolabial folds 12 months after the initial treatment.

Conditions

Nasolabial Folds

Keywords

Correction of moderate to severe nasolabial folds

Outcome Measures

Primary Outcomes (1)

• Effectiveness of study treatment in correction of nasolabial folds up to 12 months after a single treatment:

  * Investigator evaluated wrinkle severity using wrinkle severity rating scale (WSRS) * Improvement in subject and investigator rated global aesthetic improvement (GAIS) compared to baseline. * Subject satisfaction

  up to 12 months

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to 12 months

Study Arms (1)

Active treatment

EXPERIMENTAL

Device: Restylane

Interventions

Restylane DEVICE

Active treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Intent to undergo correction of both nasolabial folds
• WRSR 3-4
• Signed informed consent

You may not qualify if:

• Markedly indurate defects such as significant mid-face volume loss or prominent commissures.
• Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or in the area to be treated.
• Subjects with known hypersensitivity to any ingredient of the study product or anaesthesia used in the study.
• Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriodal anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders.
• Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids. (Inhaled corticoids are allowed).
• Cancerous or pre-cancerous lesions in the treatment area.
• Subjects who have performed aesthetic facial surgery.
• Tissue augmenting therapy with non-permanent filler or neurotoxin below the lower orbital rim in the last 12 months.
• Facial laser treatment or chemical peeling below the lower orbital rim during the last 6 months.
• Permanent implant or filler, including fat-injections, placed in the area to be treated.
• Women who are pregnant or breast feeding or who are planning to become pregnant during the study period.
• Subjects who are study site staff for this study, or close relatives (defined as parents, siblings, children or spouse) of the study site staff, as well as subjects who are employed by the sponsor company, or close relatives of employees at the sponsor company.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Plastic Surgery InstituteNo

No. 33 Badachu Road, Shijingshan District, Beijing Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 25, 2022

Record last verified: 2015-02

Locations

CN (1)