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Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

Primary Purpose

Skin Laxity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractional ablative laser
Sponsored by
Sciton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female subjects aged 18-85 years Fitzpatrick skin type I-VI Has visible skin laxity in the treatment region or has a scar Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only) Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes Subject must be able to read, understand and sign Informed Consent Form in English Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions Exclusion Criteria: Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. Any type of prior cosmetic treatment to the target area at physicians' discretion History of malignant tumors in the target area. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles. Pregnant and/or breastfeeding (Applicable to females only) Having an infection, dermatitis or a rash in the treatment area. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders. Suffering from coagulation disorders or taking prescription anticoagulation medications. History of keloid scarring, hypertrophic scarring or of abnormal wound healing. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. History of vitiligo, eczema, or psoriasis. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Sites / Locations

  • Sanctuary Plastic SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment Arm

Arm Description

Patients will receive fractional ablative treatment for laxity.

Outcomes

Primary Outcome Measures

Wrinkles
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
February 27, 2023
Sponsor
Sciton
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1. Study Identification

Unique Protocol Identification Number
NCT05750901
Brief Title
Evaluation of Fractional Ablative Laser Treatment for Skin Conditions
Official Title
Pilot Evaluation of Fractional Ablative Laser Treatment for Skin Laxity and Tightening
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sciton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the safety and efficacy of the fractional ablative laser for treatment of skin laxity and tightening

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Other
Arm Description
Patients will receive fractional ablative treatment for laxity.
Intervention Type
Device
Intervention Name(s)
Fractional ablative laser
Intervention Description
Fractional ablative laser used for treatment for skin laxity and tightening
Primary Outcome Measure Information:
Title
Wrinkles
Description
Percent improvement in wrinkles will be assessed using digital camera at baseline and post final treatment.
Time Frame
1-6 months post final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects aged 18-85 years Fitzpatrick skin type I-VI Has visible skin laxity in the treatment region or has a scar Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study (Applicable to female subjects only) Willing to have digital imaging and measurements taken of the treatment area and agree to use for presentation, educational or marketing purposes Subject must be able to read, understand and sign Informed Consent Form in English Must be willing to adhere to the treatment and follow-up schedule and post-treatment care instructions Exclusion Criteria: Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study. Any type of prior cosmetic treatment to the target area at physicians' discretion History of malignant tumors in the target area. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, large moles. Pregnant and/or breastfeeding (Applicable to females only) Having an infection, dermatitis or a rash in the treatment area. Significant concurrent illness, such as diabetes mellitus, cardiovascular disease, e.g., uncontrolled hypertension or pertinent neurological disorders. Suffering from coagulation disorders or taking prescription anticoagulation medications. History of keloid scarring, hypertrophic scarring or of abnormal wound healing. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. History of vitiligo, eczema, or psoriasis. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. Current smoker or history of smoking within 6 months of study participation. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sciton Inc.
Phone
6504939155
Email
clinicaltrials@sciton.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sciton Inc
Phone
6504939155
Email
clinicaltrials@sciton.com
Facility Information:
Facility Name
Sanctuary Plastic Surgery
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Pozner, MD
Phone
561-367-9101

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Fractional Ablative Laser Treatment for Skin Conditions

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