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Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03969485
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):

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
Skin Laxity Device: Hybrid Fractional Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
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 : April 29, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hybrid Fractional Laser
Hybrid Fractional Laser Treatment
Device: Hybrid Fractional Laser
Hybrid Fractional Laser Device
Other Name: HALO

Primary Outcome Measures :
  1. Photography [ Time Frame: 3 months ]
    Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03969485

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Contact: Sciton Inc 650-493-9155
Contact: Jay Patel 650-493-9155

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United States, New Jersey
New Jersey Clinical Research Center Recruiting
Montclair, New Jersey, United States, 07042
Contact    973-250-2996      
Sponsors and Collaborators

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Responsible Party: Sciton Identifier: NCT03969485     History of Changes
Other Study ID Numbers: HALOCIP002
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Cutis Laxa
Skin Diseases, Genetic
Genetic Diseases, Inborn
Connective Tissue Diseases
Skin Diseases