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

NCT03322475 | Unknown FDA Device

• 1 other identifier: Focus-PiQo4 Rejuvenation-17-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Rejuvenation

Outcome Measures

Primary Outcomes (2)

• Fitzpatrick Elastosis Score (FES) scale

  Fine lines/wrinkles and elastosis improvement will be classified by the Fitzpatrick-Goldman Elastosis and Wrinkles scales: Class I, Class II or Class III.

  Baseline, 1 month follow up

• Overall Global Aesthetic Improvement (GAI) Scale

  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.

  Baseline, 1 month follow up

Secondary Outcomes (1)

• Fitzpatrick Elastosis Score (FES) scale

  Baseline, 3 month follow up

Study Arms (1)

Facial skin rejuvenation

EXPERIMENTAL

Facial skin rejuvenation using PiQo4 laser system

Device: PiQo4 laser system

Interventions

PiQo4 laser system DEVICE

The PiQo4 laser system

Facial skin rejuvenation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 neurological disorder (including Multiple Sclerosis, Parkinson's disease).
• Having seizure disorder.
• Having fibromyalgia.

Sponsors & Collaborators

• Focus Medical, LLC: lead

Study Sites (1)

Scripps Clinical Research Services

La Jolla, California, 92037, United States

RECRUITING

Study Officials

• Edward Ross, MD

  Scripps Clinic Carmel Valley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Ross, MD

CONTACT

(858) 764-3023; Olafson.Tierney@scrippshealth.org

Tierney Olafson

CONTACT

(858) 764-3023; Olafson.Tierney@scrippshealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: March 12, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

US (1)