Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

Skin Laxity Clinical Trial

Official title:

Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969485
• Other study ID #: HALOCIP002
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: October 12, 2020

Study information

• Verified date: October 2020
• Source: Sciton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 12, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

Device:
• Hybrid Fractional Laser
Hybrid Fractional Laser Device

Locations

Country	Name	City	State
United States	New Jersey Clinical Research Center	Montclair	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sciton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photography	Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.	3 months