MedDataX Logo

Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

NCT ID: NCT00823069

Last Updated: 2010-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasolabial Folds

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Correction of Nasolabial Folds

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Perlane and Perlane-L

This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive.

Group Type OTHER

Perlane and Perlane-L

Intervention Type DEVICE

This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perlane and Perlane-L

This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Each subject received both Perlane-L and Perlane.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate \[3\] or both Severe \[4\])

Exclusion Criteria

* Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
* Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the Nasolabial Fold area
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Q-Med Scandinavia, Inc.

INDUSTRY

Sponsor Role collaborator

Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Medicis Global Services

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Sanstead

Role: STUDY_CHAIR

Medicis Global Pharmaceutical

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Coral Gables, Florida, United States

Site Status

Hunt Valley, Maryland, United States

Site Status

Mount Cisco, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA-1400-03

Identifier Type: -

Identifier Source: org_study_id