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Procedure
BTL-785F Device for Wrinkles
N/A
Recruiting
Research Sponsored by BTL Industries Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects willing and able to abstain from partaking in any facial or neck treatments other than the study procedure during study participation
Be older than 18 years old
Must not have
Local bacterial or viral infection in the area to be treated
Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study how a specific device, the BTL-785F, can improve the quality and texture of skin on the face and neck of healthy adult volunteers. They will take photographs before
Who is the study for?
This trial is for healthy adults who want to improve the quality and texture of their skin on the face and neck. It's not specified, but typically participants should not have any serious health issues that could affect the treatment outcome.
What is being tested?
The BTL-785F device with a specific tip and applicator is being tested for its ability to enhance skin appearance. Participants will undergo three treatments and be evaluated using photos taken before and after these sessions, up to three months post-treatment.
What are the potential side effects?
While side effects are not detailed here, similar skin treatments may cause redness, swelling, bruising or discomfort at the site of application. These usually resolve within a few days.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to have any facial or neck treatments other than what this study involves.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an infection in the area that needs treatment.
Select...
I have or had skin cancer, another type of cancer, or pre-malignant moles.
Select...
I have a history of heart or blood vessel diseases.
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My diabetes or other hormone-related conditions are not well-managed.
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I have tuberculosis.
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I have swelling or redness in the area that needs treatment.
Select...
My immune system is weakened due to an illness or medication.
Select...
I have undergone radiation therapy or chemotherapy.
Select...
I have had cancer before.
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I have an autoimmune disease that affects my skin.
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I have a bleeding disorder or I'm taking blood thinners.
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I have no active skin conditions like sores or eczema in the treatment area.
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I have wounds in the treatment area that are not healing well.
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I have an active collagen disease.
Select...
My treatment is for conditions on my eyelids or lips.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Skin Quality Improvement Assessment
Secondary study objectives
Comfort Assessed by Therapy Comfort Questionnaire
Incidence of Treatment-related Adverse Events
Satisfaction Assessed by the Subject Satisfaction Questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with BTL-785FExperimental Treatment1 Intervention
Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system.
Find a Location
Who is running the clinical trial?
BTL Industries Ltd.Lead Sponsor
54 Previous Clinical Trials
1,872 Total Patients Enrolled