Clincosm LogoSign in Get a demo

Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

Sponsor
Sciton (Industry)
Overall Status
Completed
CT.gov ID
NCT03969485
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
17.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Hybrid Fractional Laser
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
Actual Study Start Date :
Apr 29, 2019
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Oct 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hybrid Fractional Laser

Hybrid Fractional Laser Treatment

Device: Hybrid Fractional Laser
Hybrid Fractional Laser Device
Other Names:
  • HALO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Jersey Clinical Research Center Montclair New Jersey United States 07042

    Sponsors and Collaborators

    • Sciton

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sciton
    ClinicalTrials.gov Identifier:
    NCT03969485
    Other Study ID Numbers:
    • HALOCIP002
    First Posted:
    May 31, 2019
    Last Update Posted:
    Oct 20, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Cutis Laxa

    Study Results

    No Results Posted as of Oct 20, 2020