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Acne ScarsNCT05579171

Lasers to Aid in Treatment of Acne Scars

A study testing Picosecond 755nm Alexandrite Laser in people with Acne Scars, run by Goldman, Butterwick, Fitzpatrick and Groff.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acne Scars
What is being tested?
Picosecond 755nm Alexandrite Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Nov 2022to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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
  • The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated
  • History of lidocaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
  • Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
  • Presence of incompletely healed wound(s) in the treatment area
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Trial locations and contacts

No sites are listed yet.

Andrea Pacheco contact

8586571004

apacheco@clderm.com

Sherif Mikhail, MD contact

8586571004

smikhail@westderm.com

About this study

Official title: A Single Center, Evaluator-Blinded, Split-Face, Randomized Clinical Trial of Combination Treatment With Fractional Picosecond 755nm Alexandrite Laser and Radiofrequency Microneedling for Atrophic Acne Scars

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.

Read the detailed description

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.

Conditions
Acne Scars
Being tested
Picosecond 755nm Alexandrite Laser
Keywords
Acne, Scars, Acne Scars, Lasers, Cosmetic
Medical subject headings
Acne Vulgaris, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Picosecond 755nm Alexandrite LaserDevice

    Also called Alex Laser

    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

  • Picosecond 755nm Alexandrite LaserDevice

    Also called Alex Laser

    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

Study groups in NCT05579171
Study groupRoleWhat they receive
Left Side Treatment with picosecond 755nm Alexandrite laserExperimentalSubjects will have their left side of face treated with picosecond 755nm Alexandrite laser then will undergo full face radiofrequency microneedling.
Receives: Device: Picosecond 755nm Alexandrite Laser
Right Side Treatment with Picosecond 755NM Alexandrite laserExperimentalSubjects will have their right side of face treated with picosecond 755nm Alexandrite laser then will undergo full face radiofrequency microneedling.
Receives: Device: Picosecond 755nm Alexandrite Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271

  2. 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

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

  3. 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

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

  4. 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:
    3. Which is the post-treatment photograph? (A / B)
    4. Which is the treatment side? (Right / Left)

    Measured: Day 271

Secondary outcomes (3)

  1. 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

    1. Very Much Improved: Optimal cosmetic result
    2. Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal
    3. Improved: Obvious improvement in appearance from initial condition
    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 to rate each treated area) Left Facial Half Right Facial Half

    Not Treated Not Treated

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

  2. Evaluation of side effects by investigators

    Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal

    1. TRACE: Barely visible and localized
    2. MILD: Somewhat visible and diffuse
    3. MODERATE: Visible and diffuse
    4. SEVERE: Extremely visible and dense SCORES (write number under each treated area or check "Not Treated")

    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

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

  3. 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

    Measured: Day 7, Day 35, Day 63, Day 91

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion30 Oct 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579171
Sponsor's protocol ID
Potenza-Picosure-Acne Scars
Status last verified
Oct 2022
First submitted
10 Oct 2022
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Picosecond 755nm Alexandrite Laser in people with Acne Scars, run by Goldman, Butterwick, Fitzpatrick and Groff.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Pacheco (8586571004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetric analysis of change in treatment zone for acne scars using 3D imaging (time frame: Baseline, Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05579171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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