Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality

October 19, 2020 updated by: Sciton

Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Montclair, New Jersey, United States, 07042
        • New Jersey Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hybrid Fractional Laser
Hybrid Fractional Laser Treatment
Device: Hybrid Fractional Laser
Hybrid Fractional Laser Device
Other Names:
  • HALO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sciton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 12, 2020

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HALOCIP002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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