Rhytidosis FacialisNCT02626598
A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines
An observational study of Rhytidosis Facialis, run by Skin Care and Laser Physicians of Beverly Hills at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhytidosis Facialis
- What is being tested?
- Blended Belotero
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jul 2016
- How long will I take part?
- 26 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069
About this study
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.
Read the 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.
- Conditions
- Rhytidosis Facialis
- Being tested
- Blended Belotero
- Keywords
- facial wrinkles, photoaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended BeloteroDevice
Also called Treated patients
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Blended Belotero |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 24-26 weeks
Secondary outcomes (2)
Patient Diary Cards Documenting Adverse Events
Patients will be given diary cards to document any potential adverse events for 2 weeks after each treatment.
Measured: 2-4 weeks
Subject Improvement Evaluations of Treated Facial Lines
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).
Measured: 24-26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rhytidosis FacialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 26 Weeks
Sponsor and investigators
- Lead sponsor
- Skin Care and Laser Physicians of Beverly Hills
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Responsible party
- Principal investigator, Derek H. Jones, M.D., Skin Care and Laser Physicians of Beverly Hills
- Investigators
- Derek H Jones, MD, Principal investigator, Skin Care and Laser Physicians of Beverly Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626598
- Sponsor's protocol ID
- IIS2202
- Status last verified
- Dec 2015
- First submitted
- 30 Nov 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for forehead lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S155-60. doi: 10.1111/j.1524-4725.2008.34364.x.
PubMed 19021673Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
PubMed 11711957Moradi A, Shirazi A, Moradi-Poehler J, Turner J, Howell DJ. A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. Aesthet Surg J. 2015 May;35(4):443-55. doi: 10.1093/asj/sjv043.
PubMed 25908703Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.
PubMed 22316189
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Blended Belotero for the Treatment of Etched-in Fine Facial Lines
- ClinicalTrials.gov ID
- NCT02626598
- Acronym / sponsor ID
- IIS2202
- Conditions
- Rhytidosis Facialis
- Keywords
- facial wrinkles, photoaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Skin Care and Laser Physicians of Beverly HillsUniversity, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 26 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | – | Device: Blended BeloteroPatients 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blended BeloteroAlso: Treated patientsBelotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc Belotero will be injected to etched in fine facial lines | Device | Treated patients |
Primary outcome
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.
2 secondary outcomes
Patient Diary Cards Documenting Adverse Events
Time frame: 2-4 weeks
Subject Improvement Evaluations of Treated Facial Lines
Time frame: 24-26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 19021673Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated grading scale for forehead lines. Dermatol Surg. 2008 Nov;34 Suppl 2:S155-60. doi: 10.1111/j.1524-4725.2008.34364.x.
- Background: PubMed 11711957Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
- Background: PubMed 25908703Moradi A, Shirazi A, Moradi-Poehler J, Turner J, Howell DJ. A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. Aesthet Surg J. 2015 May;35(4):443-55. doi: 10.1093/asj/sjv043.
- Background: PubMed 22316189Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek H Jones, MD principal investigator
Skin Care and Laser Physicians of Beverly Hills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhytidosis Facialis, run by Skin Care and Laser Physicians of Beverly Hills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626598, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.