- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409965
Lutronic Infini and LaseMD Systems in Combination Treatment
Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Vista, California, United States, 92083
- Moradi M.D.
-
-
Florida
-
Santa Rosa Beach, Florida, United States, 32459
- The Aesthetic Clinique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Solar elastosis on the face and/or neck.
- Mild to moderate wrinkles of the face and/or neck.
- Mild to moderate textural concerns on the face and/or neck.
- Sun and/or age-related pigmentation on the face and/or neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen, or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed, i.e., a maximum of 2-3 doses in any 2-week period, if needed.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- History of keloids or poor wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated that would interfere with assessing results.
- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
- Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- BMI equal to or greater than 30.
- History of chronic drug or alcohol abuse.
- History of collagen vascular disease.
- History of autoimmune disease.
- Subjects with implanted pacemaker or defibrillator.
- Subjects with sensitivity or allergy to gold.
- Subjects with sensitivity or allergy to pre-treatment medication.
- Subjects with photosensitive skin.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- History of surgical or cosmetic treatments in the area(s) to be treated within the past year.
History or current use of the following prescription medications:
- Accutane or other systemic retinoids within the past twelve months;
- Topical Retinoids within the past two weeks; and/or
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix) within the past two weeks.
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lutronic Systems Combination Treatment
Combination treatment of the face and/or neck using the Lutronic Infini System and Lutronic LaseMD System.
|
A microneedle radiofrequency device
A fractional thulium laser device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Masked, qualitative assessment of improvement
Time Frame: 90 days following the last study treatment
|
An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors. Each blinded assessor will be given an identical set of baseline (pre-treatment) and Day 90 follow-up photos to be assessed. Each photo's visit interval, i.e., pre-treatment and follow-up, will NOT be marked. Each blinded assessor will conduct their assessment independently, comparing the Left and Right photos for improvement in the face and/or neck using the following definition:
The assessor chooses the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo. |
90 days following the last study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment-related pain
Time Frame: For the duration of each study treatment
|
During study treatments, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being the 'Worst Possible Pain'.
|
For the duration of each study treatment
|
Clinician assessment of overall aesthetic improvement
Time Frame: 90 days following the last treatment.
|
Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale, a scale that rates global aesthetic improvement from the pretreatment appearance using the following definitions:
|
90 days following the last treatment.
|
Subject assessment of overall aesthetic improvement
Time Frame: 90 days following the last treatment.
|
Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale, a scale that rates global aesthetic improvement from the pretreatment appearance using the following definitions:
|
90 days following the last treatment.
|
Patient Satisfaction
Time Frame: 90 days following study treatment
|
Patient satisfaction will be evaluated based on subjects' completion of a patient satisfaction questionnaire while referring to a hand mirror and their pre-treatment photographs and their Day 90 follow-up photographs.
Subjects will be asked to document Yes/No as to whether they notice any improvement in how their treated skin areas look; specify any changes they see in the treated areas, e.g., skin texture improvement, skin tone improvement, skin pigmentation improvement, etc.; characterize their level of satisfaction with study treatment based on 5 levels of satisfaction: Very satisfied, Satisfied, Slightly Satisfied, Neither Satisfied or Dissatisfied, Dissatisfied; document Yes/No if they would recommend the treatment to friends and family members.
|
90 days following study treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Kari Larson, MBA, Sponsor GmbH
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- L17002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Face and Neck Wrinkles, Texture, Pigmentation
-
Egyptian Atomic Energy AuthorityWaleed Nemr,Egyptian Atomic Energy AuthorityCompletedFacial Wrinkles - Rough Texture - HyperpigmentationEgypt
-
California Allergy and Asthma Medical Group, Inc.UnknownSkin Wrinkles on Face and Neck AreasUnited States
-
Syneron MedicalUnknownSkin Pigmentation and Texture Disorders.Argentina
-
Candela CorporationCompletedSkin Texture Irregularities | Facial Skin WrinklesUnited States
-
Galderma R&DCompletedWrinkles and Folds in Lower FaceGermany
-
Lumenis Be Ltd.CompletedImprovement of Wrinkles/Elastosis and/or PigmentationUnited States, Germany
-
University of PittsburghRecruiting
-
Menarini (Thailand) LimitedCompletedSkin Roughness | Mottling | Blotchiness | Pigmentation | Fine WrinklesThailand
-
Alma Lasers Inc.Unknown
-
King Edward Medical UniversityUnknownSkin Pigmentation Over Contour Deformities of Face | Trauma, Rhomberg DiseasePakistan
Clinical Trials on Lutronic Infini System
-
Aarhus University HospitalBispebjerg HospitalUnknownAcne Scars - Mixed Atrophic and HypertrophicDenmark
-
LUTRONIC CorporationCompletedWrinkle | Skin Laxity | Skin Texture DisorderUnited States
-
Montefiore Medical CenterWithdrawnAndrogenetic AlopeciaUnited States
-
Seoul National University HospitalCompletedScar | AcneKorea, Republic of
-
Yonsei UniversityCompleted
-
Montefiore Medical CenterWithdrawn
-
Johns Hopkins UniversityCompleted
-
ResMedCompleted
-
Federal University of São PauloCompletedAdverse Reaction to Systemic AgentsBrazil