Lasers to Aid in Treatment of Acne Scars

NCT05579171 | Unknown FDA Device

• 1 other identifier: Potenza-Picosure-Acne Scars
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acne Scars

Keywords

Acne; Scars; Acne Scars; Lasers; Cosmetic

Outcome Measures

Primary Outcomes (4)

• 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 1. a few scars 2. limited number of scars 3. many scars U-shaped atropic scars, diameter of 2-4 mm, with sheer edges 0= no scar 1. a few scars 2. limited number of scars 3. many scars M-shaped atrophic scars, diameter of more than 4mm, superficial and with irregular surface 0= no scar 1. a few scars 2. limited number of scars 3. many scars Superficial elastolysis 0= absent 1. mild 2. moderate 3. intense Hypertrophic inflammatory scars, scars of less than 2 years of age 0= no scar 1. a few scars 2. limited number of scars 3. many scars Keloid scars, hypertrophic scars, of more than 2 years of age 0= no scar 1. a few scars 2. limited number of scars 3. many scars

  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 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Left Facial Half Right Facial Half Not Treated Not Treated

  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: 1. Do you see an improvement in photoaging between the two sets of photos? (Yes / No) 2. If yes to question #1: 1. Which is the post-treatment photograph? (A / B) 2. Which is the treatment side? (Right / Left)

  Day 271

Secondary Outcomes (3)

• Subject Global Aesthetic Improvement Scale (SGAIS)

  Day 35, Day 63, Day 91, Day 121, Day 181, Day 271

• Evaluation of side effects by investigators

  Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271

• Ultrasound imaging measurements of dermal edema

  Day 7, Day 35, Day 63, Day 91

Study Arms (2)

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.

Device: Picosecond 755nm Alexandrite Laser

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.

Device: Picosecond 755nm Alexandrite Laser

Interventions

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

Also known as: Alex Laser

Left Side Treatment with picosecond 755nm Alexandrite laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
• Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

You may not qualify if:

• Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
• The subject is hypersensitive to light in the near infrared wavelength region
• The subject is taking medication which is known to increase sensitivity to sunlight
• The subject has a seizure disorders triggered by light
• The subject is receiving or have received gold therapy
• The subject has a pacemaker
• The subject has a metal implant that interferes with the transmission of energy to the electrical field
• The subject has any embedded electronic devices that give or receive a signal such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant
• Gold allergy
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder
• The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated
• Dermal fillers, neuromodulator, biostimulatory injectables, fat grafting, radiofrequency device treatments, microfocused ultrasound device treatments, laser and light-based device treatments, microneedling to the face during the 6-month period before study treatment m) Subjects with tattoos in the treatment areas n) Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
• History of keloid or hypertrophic scarring
• Subjects with an active bacterial, viral, or fungal infection of the treatment areas

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Cynosure, LLC: collaborator

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Andrea Pacheco

CONTACT

8586571004; apacheco@clderm.com

Sherif Mikhail, MD

CONTACT

8586571004; smikhail@westderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded Investigator will be unaware of which side received both treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10