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To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.
subject will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half.
For additional comfort, cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5 will be used throughout the treatment. After each treatment, subjects will be provided with CeraVe gentle facial cleanser (CeraVe; New York, NY) and CeraVe lotion (CeraVe; New York, NY) to be used twice daily for two weeks. Additionally, a mineral CeraVe sunscreen (CeraVe; New York, NY) will also be provided to subjects to be used every morning with reapplication every two (2) hours if going outside for the entirety of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A = right side face treated with 1064nm and left with 755nm | Experimental | subject will have their right half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, left half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. |
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| Group B = left side face treated with 1064nm and right with 755nm | Experimental | subject will have their left half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, right half will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1064NM pico Laser | Device | There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Scientific Assessment Scale of Skin Quality (SASSQ) to assess change | Scientific Assessment Scale of Skin Quality (SASSQ) (circle one) Elasticity 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Wrinkles 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Skin Surface Roughness 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Lentigines/ Pigmentation 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Erythema 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Pore Size 0- Fine 1- Small 2- Moderate 3- Large 4- Very Large | Screening, Baseline, Day 28, Day 56, Day 140 |
| Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change | Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description
Left Facial Half Right Facial Half Not Treated Not Treated | Day 28, Day 56, Day 140 |
| Percent improvement of skin quality by blinded investigator to assess change | Blinded Investigator Percent Improvement Evaluation - Left Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) Blinded Investigator Percent Improvement Evaluation - Right Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) | Day 28, Day 56, Day 140 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (SGAIS) | Subject Global Aesthetic Improvement Scale Assessment (SGAIS) How would you rate the change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you. Rating Description
Left Facial Half Right Facial Half Not Treated Not Treated |
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Inclusion Criteria:
Adult males and females aged 18 to 65 years
Fitzpatrick skin types I-VI
Subjects in good general health based on investigator's judgment and medical history
Must be willing to give and sign an informed consent form and photographic release form
Willingness to have facial exams and digital photographs performed of the face
Physician evaluator classifying the subject as moderate or severe in all categories of the Scientific Assessment Scale of Skin Quality (SASSQ): elasticity, wrinkles, skin surface roughness, lentigines/pigmentation, erythema, blemishes, and pore size
No change in topical skin care regimen for duration of study
Must be willing to maintain usual sun exposure
Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
Negative urine pregnancy test result at the time of study entry (if applicable)
For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
Must be willing to comply with study treatments and complete the entire course of the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 8586571004 | apacheco@clderm.com | |
| Sherif Mikhail, MD | Contact | 8586571004 | smikhail@westderm.com |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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subjects will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array.
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the blinded investigator will complete the Scientific Assessment Scale of Skin Quality (SASSQ). , the blinded investigator will complete the Physician Global Aesthetic Improvement Scale (PGAIS) and percent improvement evaluation. Percent Improvement Evaluation by Blinded investigator .
Subjects are blinded to which side receives which laser
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| 755NM pico Laser | Device | There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality. |
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| Day 28, Day 56, Day 140 |
| Subject Satisfaction Questionnaire | Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you. Rating Description 0 Not satisfied
Left Facial Half Right Facial Half | Day 140 |
| Comfort level visual analog scale post-procedure by subjects | Visual Analog Scale - Left Facial Half Visual Analog Scale (Circle One) 1 2 3 4 5 6 7 8 9 10 Visual Analog Scale - Right Facial Half Visual Analog Scale (Circle One) 1 2 3 4 5 6 7 8 9 10 | Baseline, Day 28, Day 56 |
| Evaluation of side effects and adverse effects by investigators | Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal
Edema Left Facial Half Right Facial Half Hyperpigmentation Left Facial Half Right Facial Half Hypopigmentation Left Facial Half Right Facial Half Bruising Left Facial Half Right Facial Half Ulcer Left Facial Half Right Facial Half | Baseline, Day 28, Day 56, Day 140 |