- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214873
Evaluation of the Effectiveness of the PiQo4 System for Reduction of Infra-orbital Pigmentation
A Pilot Study to Evaluate the Effectiveness of the PiQo4 Picosecond Laser (PSL) System for Reduction of Infra-orbital Pigmentation
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mitchel P Goldman, MD
- Phone Number: 858.657.1002
- Email: mgoldman@CLderm.com
Study Contact Backup
- Name: Leslie Aguilar
- Phone Number: 120 858.657.1004
- Email: laguilar@clderm.com
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Cosmetic Laser Dermatology, A West Dermatology Company
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females or males
- Age 18-65
- Fitzpatrick skin types I-IV
- POH on the background of epidermal and/or dermal pigmentation
- POH severity - mild to moderate
- Able to read, understand and provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and post treatment care
- Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period)
- Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
- Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions
- Agreed to have their face photographed and 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
Women of childrearing potential (not postmenopausal [no menstrual cycle for at least 12 months], without an uterus and/or both ovaries, or has had a bilateral tubal ligation)
*(In case of women of childbearing potential) Tested negative in the pregnancy test and agreed to use birth control measures during the clinical trial period including use of contraceptives (see list below) IUD, Double-Barrier Method, Vasectomized Partner, No Heterosexual Intercourse, etc
- Agreed not to undergo any other procedure on their face during their participation in the clinical trial
Exclusion Criteria:
- Pregnant or breastfeeding
- Inability to comply with all study protocols and regulations
- Participation in a study of another device or drug
- Heavy smokers and/or drinkers (those who smoke 25 or more cigarettes a day and/or ⩾8 drinks a week for women, and ⩾15 for men)
- Application of any energy device treatment to the infraorbital region within 3 months
- Application of any dermal filler to the infraorbital region within 6 months
- Facial resurfacing, deep chemical peels, or taking oral retinoids within 6 months
- Microdermabrasion (light or medium skin peel) treatment within 30 days
- Chemical peel, systemic steroids, non-ablative laser, light, or radiofrequency treatment within 3 months
- Use of topical lightening agents or retinoids within 14 days
- Any planned surgical intervention to the face for the duration of the trial
- Use of Latisse, Revitalash, or other lash enhancement stimulators as well as Bimatoprost in the previous 1 month
- Presence of open wounds, lesions, or scarring in the area
- Very thin skin (skin that tears, bruises, or breaks easily)
- Suffering from current or history of significant skin conditions in the treated area that could interfere with the evaluation (i.e. infection, dermatitis, or rash on their face) or requires the use of interfering topical or systemic therapy.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex (HSV, HZO) in the treated area, unless treatment is conducted following a prophylactic regimen
- History of keloid scarring, hypertrophic scarring, or of abnormal wound healing.
- History of connective tissue diseases such as systemic lupus erythematosus or scleroderma
- History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
- History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis.
- Has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present
- History of skin cancer
- Change of contraceptives dosing in the past 3 months
- Medical disorders such as thyroid or kidney diseases
- Significant concurrent illness 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
Study Plan
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: POH
Treatment of POH Using PiQo4 Laser System
|
PiQo4 Laser System for treatment of POH
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in POH severity
Time Frame: 3 month follow up
|
POH improvement of at least 1 point evaluated by the investigator at the 3-month follow up compared to baseline using the POH severity in comparison to surrounding skin scale where score of between 0 and 4 will be assigned (0-Normal (Skin color comparable to other facial skin areas); 1- Trace (Faint pigmentation of infraorbital fold (bilateral)); 2- Mild (Pigmentation more pronounced); 3- Moderate (Deep dark colour, all four lids involved): ; 4 - Marked (Grade 3 + pigmentation spreading beyond infraorbital fold)
|
3 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aesthetic improvement
Time Frame: 3 month follow up
|
Aesthetic improvement evaluated by the investigator at the 3-month follow up compared to baseline using a 5-point improvement scale (GAIS) where a score of between 0 and 4 will be assigned (0-Worse (The appearance is worse than the original condition.);
1- No Change (The appearance is essentially the same as the original condition); 2- Improved (Obvious improvement in appearance from initial condition, but a touch-up or re-treatment is indicated.);
3- Much improved (Marked improvement in appearance from initial condition, but not completely optimal.
A touch-up would slightly improve the result.);
4 - Very much improved (Optimal result)
|
3 month follow up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Focus-PiQo4 POH-19-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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