Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645366
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Device for Improving Skin Quality and Texture on the Face and Neck
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Safety and Efficacy of the BTL-785F Device for Improvement in Skin Quality and Texture on Face and Neck
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the effect of the BTL-785F device with BTL-785-4-4 tip on BTL-785-4 applicator on the improvement of skin quality and texture on the face and neck in healthy adult volunteers The main question it aims to answer is
Whether the BTL-785F device with BTL-785-4-4 tip on BTL-785-4 applicator is able to improve skin quality 3 months post-treatment as assessed by two-dimensional and three-dimensional photographs
Participants will complete three treatments and two follow-up visits
Whether the BTL-785F device with BTL-785-4-4 tip on BTL-785-4 applicator is able to improve skin quality 3 months post-treatment as assessed by two-dimensional and three-dimensional photographs
Participants will complete three treatments and two follow-up visits
Detailed Description:
This study will evaluate the safety and efficacy of the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator for the improvement of skin quality and texture on the face and neck It is a prospective multi-center open label one-arm study
Subjects will be required to complete three 3 treatment visits and two 2 follow-up visits at 1 month 3 months post-treatment
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient 2D and 3D photographs of the subjects will be taken
The treatment administration phase consists of three 3 treatment visits delivered 2 - 6 weeks apart after the complete healing of scabs Before the second and third treatment 2D and 3D photographs will be taken After each treatment subjects will be asked to fill in the Therapy Comfort Questionnaire for the assessement of subjects comfort during the treatments After the last treament subjects will receive Subject Satisfaction Questionnaire to record subjects satisfaction with the treatment results
At both follow-up visits subjects will receive Subject Satisfaction Questionnaire to fill in and 2D and 3D photographs will be taken
Safety measures will include documentation of adverse events AE during and after the treatment procedures and at the follow-up visits and if needed medical assistance
Subjects will be required to complete three 3 treatment visits and two 2 follow-up visits at 1 month 3 months post-treatment
At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient 2D and 3D photographs of the subjects will be taken
The treatment administration phase consists of three 3 treatment visits delivered 2 - 6 weeks apart after the complete healing of scabs Before the second and third treatment 2D and 3D photographs will be taken After each treatment subjects will be asked to fill in the Therapy Comfort Questionnaire for the assessement of subjects comfort during the treatments After the last treament subjects will receive Subject Satisfaction Questionnaire to record subjects satisfaction with the treatment results
At both follow-up visits subjects will receive Subject Satisfaction Questionnaire to fill in and 2D and 3D photographs will be taken
Safety measures will include documentation of adverse events AE during and after the treatment procedures and at the follow-up visits and if needed medical assistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None