Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
Primary Purpose
Skin Laxity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid Fractional Laser
Sponsored by
About this trial
This is an interventional treatment trial for Skin Laxity
Eligibility Criteria
Inclusion Criteria:
- Healthy male/female subjects between 40 to 65 years of age inclusive
- Fitzpatrick skin type I-III
- Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
- Has poor skin texture
- Has mild thin skin
- Has some level of dyschromia on the treatment area as assessed by the Investigator
- Can read, understand and sign informed consent form (English only)
- Has indicated willingness to participate in the study by signing an informed consent form
- Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Exclusion Criteria:
- Fitzpatrick skin type IV-VI
- Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
- Has tattoos, dysplastic nevi on the treatment area
- Is pregnant and/or lactating
- History or current photosensitivity
- History or current use of medication with photosensitizing properties within past 6 months
- History or current of chronic reoccurring skin disease or disorder affecting treatment area
- History or current cancer of any type
- Has signs of actinic bronzing
- Has open lacerations, and abrasions on the treatment area
- History of keloid formation, or hypertrophic scar formation, or poor wound healing
- History of bleeding disorder, or is currently taking anticoagulation medications
- Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
- Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
- The investigator feels that for any reason the subject is not eligible to participate in the study
Sites / Locations
- New Jersey Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hybrid Fractional Laser
Arm Description
Hybrid Fractional Laser Treatment
Outcomes
Primary Outcome Measures
Photography
Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03969485
Brief Title
Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
Official Title
Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 12, 2020 (Actual)
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
5. Study Description
Brief Summary
To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs
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
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid Fractional Laser
Arm Type
Experimental
Arm Description
Hybrid Fractional Laser Treatment
Intervention Type
Device
Intervention Name(s)
Hybrid Fractional Laser
Other Intervention Name(s)
HALO
Intervention Description
Hybrid Fractional Laser Device
Primary Outcome Measure Information:
Title
Photography
Description
Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male/female subjects between 40 to 65 years of age inclusive
Fitzpatrick skin type I-III
Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
Has poor skin texture
Has mild thin skin
Has some level of dyschromia on the treatment area as assessed by the Investigator
Can read, understand and sign informed consent form (English only)
Has indicated willingness to participate in the study by signing an informed consent form
Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Exclusion Criteria:
Fitzpatrick skin type IV-VI
Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
Has tattoos, dysplastic nevi on the treatment area
Is pregnant and/or lactating
History or current photosensitivity
History or current use of medication with photosensitizing properties within past 6 months
History or current of chronic reoccurring skin disease or disorder affecting treatment area
History or current cancer of any type
Has signs of actinic bronzing
Has open lacerations, and abrasions on the treatment area
History of keloid formation, or hypertrophic scar formation, or poor wound healing
History of bleeding disorder, or is currently taking anticoagulation medications
Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
The investigator feels that for any reason the subject is not eligible to participate in the study
Facility Information:
Facility Name
New Jersey Clinical Research Center
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
12. IPD Sharing Statement
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Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
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