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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial skin rejuvenation | Experimental | Facial skin rejuvenation using PiQo4 laser system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PiQo4 laser system | Device | The PiQo4 laser system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fitzpatrick Elastosis Score (FES) scale | 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. | Baseline, 3 month follow up |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be entered into 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward Ross, MD | Contact | (858) 764-3023 | Olafson.Tierney@scrippshealth.org | |
| Tierney Olafson | Contact | (858) 764-3023 | Olafson.Tierney@scrippshealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Edward Ross, MD | Scripps Clinic Carmel Valley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinical Research Services | Recruiting | La Jolla | California | 92037 | United States |
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