Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

NCT ID: NCT03969485

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2020-10-12

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

Conditions

Skin Laxity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid Fractional Laser

Hybrid Fractional Laser Treatment

Group Type: EXPERIMENTAL

Hybrid Fractional Laser

Intervention Type: DEVICE

Hybrid Fractional Laser Device

Interventions

Hybrid Fractional Laser

Hybrid Fractional Laser Device

Intervention Type: DEVICE

Other Intervention Names

HALO

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sciton

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New Jersey Clinical Research Center

Montclair, New Jersey, United States

Countries

United States

Other Identifiers

HALOCIP002

Identifier Type: -

Identifier Source: org_study_id