Skin Laxity
Conditions
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
Interventions
DEVICEHybrid Fractional Laser
Hybrid Fractional Laser Device
Sponsors
Sciton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male/female subjects between 40 to 65 years of age inclusive 2. Fitzpatrick skin type I-III 3. Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit 4. Has poor skin texture 5. Has mild thin skin 6. Has some level of dyschromia on the treatment area as assessed by the Investigator 7. Can read, understand and sign informed consent form (English only) 8. Has indicated willingness to participate in the study by signing an informed consent form 9. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Exclusion criteria
1. Fitzpatrick skin type IV-VI 2. 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 3. Has tattoos, dysplastic nevi on the treatment area 4. Is pregnant and/or lactating 5. History or current photosensitivity 6. History or current use of medication with photosensitizing properties within past 6 months 7. History or current of chronic reoccurring skin disease or disorder affecting treatment area 8. History or current cancer of any type 9. Has signs of actinic bronzing 10. Has open lacerations, and abrasions on the treatment area 11. History of keloid formation, or hypertrophic scar formation, or poor wound healing 12. History of bleeding disorder, or is currently taking anticoagulation medications 13. Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment 14. Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days 15. The investigator feels that for any reason the subject is not eligible to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photography | 3 months | Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement. |
Countries
United States
Outcome results
None listed