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OpenTrials
Completed

NCT Number: NCT03969485

Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Jersey Clinical Research Center

Montclair, New Jersey, 07042, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hybrid fractional laser

Device

Hybrid Fractional Laser Device

Other names: HALO

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sciton

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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