A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines

December 7, 2015 updated by: Derek H. Jones, M.D., Skin Care and Laser Physicians of Beverly Hills
This is a single center study for adult females or males ages 25 to 75 years who are seeking treatment for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead. The purpose of this study is to evaluate blended Belotero for the treatment of etched-in fine facial lines and to monitor for adverse events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a study to evaluate the effects of Belotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc of Belotero in the treatment of etched-in fine facial lines. 30 adults scheduled to have blended Belotero injected into fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead will be evaluated. The blended Belotero will be injected intradermally into these etched-in fine lines. The patients will be given diary cards to document potential adverse events. 2 weeks after receiving injections of the blended Belotero the subjects will return to have photographs taken, have their treated fine lines evaluated, and complete a self assessment questionnaire. Touch-up injections are common clinical practice and if additional touch-ups would improve their result, those subjects can be re-treated at this visit. Those subjects who are touched up will return to the clinic for an additional follow up visit and photographs 2 weeks later. All subjects will return to the clinic 12 weeks and 24 weeks after their last injection for photographs and evaluations. Improvement assessments will be made by investigator ratings at each visit. Investigator ratings for the cutaneous lip and the forehead area are based on the Merz Aesthetic Validated Assessment Scales. Investigator ratings for the radial cheek area, nasolabial folds, and melolabial folds are based on the Validated Lemperle Facial Wrinkle Scales.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90069
        • Skin Care and Laser Physicians of Beverly Hills

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a single-center observational study of adult females and males ages 25 to 75 years who are scheduled to have treatment with Belotero blended with lidocaine with epinephrine, as is common in clinical practice for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead area. After reviewing the risks and benefits of the procedure, the patient will sign a clinical consent form prior to treatment. If the patient is amenable to participate in the study and agrees to have pre and post treatment photographs and evaluations completed, they will proceed to sign the research consent form and will be enrolled into the study.

Description

Inclusion Criteria:

  • Adult females and males, aged 25-75 years.
  • Subjects must be seeking treatment for etched-in fine lines of the cutaneous lip area, and/or radial cheek area, and/or nasolabial fold area, and/or melolabial fold area, and/or forehead area.
  • Subjects must have one or more etched-in fine line on the cutaneous lip area, and/or radial cheek area, and/or nasolabial fold area, and/or melolabial fold area, and/or forehead area.
  • Subjects must have been deemed eligible by the treating physician and be scheduled for treatment of etched-in fine facial lines with Belotero blended with lidocaine with epinephrine.
  • Subjects must be willing to defer any other cosmetic procedures in the treatment area while in the study. They can continue using topicals with retinoids, retinol, beta hydroxy acids, or alpha hydroxyl acids if they were previously using these topicals for at least 3 months prior to starting the study, but they should not initiate cosmetic treatments with new topicals during the study period. They should not have cosmetic treatments such as chemical peels, microdermabrasion, microneedling procedures, laser procedures, botulinum toxin injections, or other injectable filler therapy in the treatment area during the study period.
  • Subjects must be willing and able to provide written informed consent in English
  • Subjects must be willing and able to follow the procedures outlined in this protocol.

Exclusion Criteria:

  • Subjects who are pregnant.
  • Subjects with previous permanent injectable filler therapy to the treatment area.
  • Subjects with previous non-permanent injectable filler therapy to the treatment area within the past year.
  • Subjects with previous botulinum toxin injections in the treatment area within the past 6 months.
  • Subjects with severe baseline facial lines in the treatment area with a score of 5 based on the Validated Lemperle Facial Wrinkle Scales.
  • Subjects with visible scars in the treatment area that may affect evaluation of response and/or quality of photography in the opinion of the investigator.
  • Known allergy or sensitivity to any of the treatment injections or their components, including or known or suspected lidocaine hypersensitivity.
  • Subjects with an infection in the treatment area.
  • Subjects are not to undergo any additional cosmetic procedures in the treatment area during the study period.
  • Subjects with a history of poor cooperation, non-compliance with medical treatment, or unrealiability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Treated patients
Patients treated with blended Belotero for etched-in fine lines of the cutaneous lip, and/or radial cheek area, and/or nasolabial folds, and/or melolabial folds, and/or forehead area will be evaluated with photographs, physician ratings, and patient improvement assessments.
Device: Blended Belotero
Belotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc Belotero will be injected to etched in fine facial lines
Other Names:
  • Treated patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Investigator Fine Facial Line Evaluations (Merz Aesthetic Validated Assessment Scales for cutaneous lip and the forehead and Validated Lemperle Facial Wrinkle Scales for the radial cheek, nasolabial folds, and melolabial folds)
Time Frame: 24-26 weeks
Investigator evaluations and ratings of fine facial lines will be made at each visit. Investigator ratings for the cutaneous lip and the forehead area are based on the Merz Aesthetic Validated Assessment Scales. Investigator ratings for the radial cheek area, nasolabial folds, and melolabial folds are based on the Validated Lemperle Facial Wrinkle Scales.
24-26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Diary Cards Documenting Adverse Events
Time Frame: 2-4 weeks
Patients will be given diary cards to document any potential adverse events for 2 weeks after each treatment.
2-4 weeks
Subject Improvement Evaluations of Treated Facial Lines
Time Frame: 24-26 weeks
Subject improvement evaluations will be made at each visit with exception to the first visit. Subjects will rate the percent improvement of the treated facial lines (0-25% Improvement, 25-49% Improvement, 50-74% Improvement, or 75-100% Improvement).
24-26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Skin Care and Laser Physicians of Beverly Hills

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merz Aesthetics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Derek H Jones, MD, Skin Care and Laser Physicians of Beverly Hills

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIS2202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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