Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

NCT03969485 | Completed FDA Device

• 1 other identifier: HALOCIP002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hybrid Fractional Laser

EXPERIMENTAL

Hybrid Fractional Laser Treatment

Device: Hybrid Fractional Laser

Interventions

Hybrid Fractional Laser DEVICE

Hybrid Fractional Laser Device

Also known as: HALO

Hybrid Fractional Laser

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sciton: lead

Study Sites (1)

New Jersey Clinical Research Center

Montclair, New Jersey, 07042, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: April 29, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 12, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

US (1)