Evaluation of the Efficacy and Safety of PiQo4 for Facial Skin Rejuvenation
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|ClinicalTrials.gov Identifier: NCT03322475|
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Skin Rejuvenation||Device: PiQo4 laser system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Facial skin rejuvenation
Facial skin rejuvenation using PiQo4 laser system
Device: PiQo4 laser system
The PiQo4 laser system
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03322475
|Contact: Edward Ross, MD||(858) 764-3023||Olafson.Tierney@scrippshealth.org|
|Contact: Tierney Olafson||(858) 764-3023||Olafson.Tierney@scrippshealth.org|
|United States, California|
|Scripps Clinical Research Services||Recruiting|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Edward Ross, MD||Scripps Clinic Carmel Valley|