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Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation

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: NCT03322475
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 7, 2019
Information provided by (Responsible Party):
Focus Medical, LLC

Brief Summary:
A total of at least 20 healthy subjects at a single site, with at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars who wish to improve their skin appearance will be enrolled into the study. subjects will receive 3 treatments and return to follow-up visits at 1, 3, and 6 months following the last treatment.

Condition or disease Intervention/treatment Phase
Skin Rejuvenation Device: PiQo4 laser system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Experimental: Facial skin rejuvenation
Facial skin rejuvenation using PiQo4 laser system
Device: PiQo4 laser system
The PiQo4 laser system

Primary Outcome Measures :
  1. Fitzpatrick Elastosis Score (FES) scale [ Time Frame: Baseline, 1 month follow up ]
    Fine lines/wrinkles and elastosis improvement will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales: Class I, Class II or Class III.

  2. Overall Global Aesthetic Improvement (GAI) Scale [ Time Frame: Baseline, 1 month follow up ]
    The global aesthetic improvement (GAI) scale will be used by the investigator to grade improvement in the following categories: 1) Fine lines/wrinkles; 2) texture 3) Pigmentation 4) Acne scars. Score 0-Worse, Score 1-No Change, Score 2- Somewhat improved, Score 3- Moderately improved, Score 4-Very Much Improved.

Secondary Outcome Measures :
  1. Fitzpatrick Elastosis Score (FES) scale [ Time Frame: Baseline, 3 month follow up ]

    Skin improvement on the FES scale will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales at the 3 month-follow-up visits as compared to baseline.

    Classification: Class I, Class II or Class III.

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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be entered into the study:

  • Healthy Female/Male.
  • Age= 18-70 (Adults).
  • Fitzpatrick skin phototype = I-V
  • Exhibiting at least two facial sub-areas with visible wrinkles with pigmentation and/or acne scars.
  • Able to read, understand and provide written Informed Consent.
  • Able and willing to comply with the treatment/follow-up schedule and post treatment care
  • Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
  • Willingness to allow Focus Medical (the study Sponsor) and Lumenis and the investigators to use de-identified photographs of the treated area for presentation and publication purposes.
  • Daily use of sunscreen for the duration of the study
  • Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.

Exclusion Criteria:

Any of the following will exclude the subject from the study:

  • Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
  • Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.
  • Known hypersensitivity or contraindications to anesthetic agents including lidocaine and its derivatives, and Toradol.
  • Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
  • History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
  • Having Melasma.
  • Having multiple dysplastic Nevi in are to be treated.
  • Having an excessive underlying vascular conditions (e.g. dense network of capillaries).
  • History of keloid scarring or of abnormal wound healing.
  • Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
  • History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  • Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion).
  • Having a neurological disorder (including Multiple Sclerosis, Parkinson's disease).
  • Having seizure disorder.
  • Having fibromyalgia.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • Participation in a study of another device or drug within three months prior to enrolment or during the study.
  • Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
  • Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area.
  • Received the following treatments in the area of the face to be treated during or within the noted timeframes prior to the study treatment:

    1. Dermabrasion or chemical peel treatment within 3 months.
    2. Any devices and/or Botox treatment within 6 months.
    3. Collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months.
    4. Resurfacing procedure, face lift or eyelid surgery within a year.
    5. Having a permanent implant in the facial skin area, such as an injected chemical substance.
    6. Any other surgery in treated area within 9 months of initial treatment or during the course of the study
    7. Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months and oral retinoids within 6 months of 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): NCT03322475

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Contact: Edward Ross, MD (858) 764-3023
Contact: Tierney Olafson (858) 764-3023

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United States, California
Scripps Clinical Research Services Recruiting
La Jolla, California, United States, 92037
Sponsors and Collaborators
Focus Medical, LLC
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Principal Investigator: Edward Ross, MD Scripps Clinic Carmel Valley
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Responsible Party: Focus Medical, LLC Identifier: NCT03322475    
Other Study ID Numbers: Focus-PiQo4 Rejuvenation-17-02
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes