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| Name | Class |
|---|---|
| Cynosure, LLC | UNKNOWN |
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To assess efficacy and safety of paired picosecond 755nm Alexandrite laser with focused lens array (PSAL; Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (RFM; Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scars.
The primary objective of this clinical trial is to assess efficacy and safety of combination treatment with fractional picosecond 755nm Alexandrite laser with focused lens array (Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scarring.
Enrolled subjects will be randomized to receive picosecond 755 nm Alexandrite laser treatment to either the left or right facial half. The subjects will then undergo full face radiofrequency microneedling (RFM).
Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photographs will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left Side Treatment with picosecond 755nm Alexandrite laser | Experimental | Subjects will have their left side of face treated with picosecond 755nm Alexandrite laser then will undergo full face radiofrequency microneedling. |
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| Right Side Treatment with Picosecond 755NM Alexandrite laser | Experimental | Subjects will have their right side of face treated with picosecond 755nm Alexandrite laser then will undergo full face radiofrequency microneedling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picosecond 755nm Alexandrite Laser | Device | Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric analysis of change in treatment zone for acne scars using 3D imaging | 3D photography will be taken Standardized 3D Vectra Photography with standard lighting and camera positioning to ensure comparable before and after treatment photographs of the face. Photographs will be taken, capturing three (3) views of the hip area: anterior, right oblique (45°), and left oblique (45°). 3D photography is taken at every time frame to compare the appearance of acne scars to the previous photo. | Baseline, Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271 |
| ECCA acne grading scale by blinded investigator to assess change | Blinded Investigator ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale V-Shaped atrophic scars, diameter of less than 2mm, and punctiform 0= no scar
U-shaped atropic scars, diameter of 2-4 mm, with sheer edges 0= no scar
M-shaped atrophic scars, diameter of more than 4mm, superficial and with irregular surface 0= no scar
Superficial elastolysis 0= absent
Hypertrophic inflammatory scars, scars of less than 2 years of age 0= no scar
Keloid scars, hypertrophic scars, of more than 2 years of age 0= no scar
| Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271 |
| Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator | Blinded Investigator Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description
Scores (write a number under each treated area or check "Not Treated") Left Facial Half Right Facial Half Not Treated Not Treated |
| 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
Not Treated Not Treated |
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Inclusion Criteria:
Adult males and females aged 18 or older
Subjects in good general health based on investigator's judgment and medical history
Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study
Understands and accepts the obligation and is logistically able to be present for all visits
Is willing to comply with all requirements of the study and sign the informed consent documents
Must be willing to maintain usual sun exposure for the duration of the study
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.
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 |
|---|---|
| D000152 | Acne Vulgaris |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Enrolled subjects will be randomized to receive picosecond 755 nm Alexandrite laser treatment to either the left or right facial half. The subjects will then undergo full face radiofrequency microneedling (RFM).
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Blinded Investigator will be unaware of which side received both treatments.
|
| Picosecond 755nm Alexandrite Laser | Device | Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime |
|
|
| Day 35, Day 63, Day 91, Day 121, Day 181, Day 271 |
| Blinded Identification of correct treatment area by blinded investigator | The baseline (Day 0) and 6 month (Day 259) photographs will be randomly put side-by-side and labeled either (A) or (B). The blinded investigator will then fill out the following:
| Day 271 |
| Day 35, Day 63, Day 91, Day 121, Day 181, Day 271 |
| Evaluation of side effects by investigators | Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal
Erythema Left Facial Half Right Facial Half Not Treated Not Treated Edema Left Facial Half Left Facial Half Not Treated Not Treated Bruising/Petechiae Left Facial Half Left Facial Half Not Treated Not Treated Ulcers Left Facial Half Left Facial Half Not Treated Not Treated Hyperpigmentation/Hypopigmentation Left Facial Half Left Facial Half Not Treated Not Treated | Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271 |
| Ultrasound imaging measurements of dermal edema | Treating investigator measurement of Sub-Dermal Edema by ultrasonography Treating Investigator Measurement of Sub-Dermal Edema by Ultrasonography Depth of dermis (mm) Ultrasound images will be obtained at the point of intersection when a horizontal line is drawn from the ala to the tragus and a vertical line is drawn from the lateral canthus to the lateral oral commissure. Left Facial Half Right Facial Half | Day 7, Day 35, Day 63, Day 91 |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |