Acne ScarsNCT04807179
Clinical Study to Evaluate Alexandrite Laser for the Treatment of Acne Scars
A study testing Experimental: RF Device Arm in people with Acne Scars, run by Cynosure, Inc. at 2 sites in United States.
Trial summary
The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Scars
- What is being tested?
- Experimental: RF Device Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2021to 2 Aug 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A healthy male or female 18 - 65 years of age.
- Has acne scars on the face (left, right, or front) and willing to undergo treatments with the study device.
- Is a skin type V or VI.
- 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 document.
Who cannot join
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- The subject is hypersensitive to light in the near infrared wavelength region.
- The subject takes medication which is known to increase sensitivity to sunlight.
- The subject has seizure disorders triggered by light.
- The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
- The subject has an active localized or systemic infection, or an open wound in area being treated.
Show all 19Show fewer
- The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
- The subject has common acquired nevi that are predisposed to the development of malignant melanoma.
- The subject has herpes simplex in the area being treated.
- The subject is receiving or has received gold therapy.
- The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
- Cautionary Criteria:
- The subject has had unprotected sun exposure within four weeks of treatment, including the use of tanning beds or tanning products, such as creams, lotions and sprays.
- The subject has a history of immunosuppression/immune deficiency or an auto-immune disorder.
- The subject has a coagulation disorder or currently using anticoagulation medication, including heavy use of aspirin.
- The subject is taking medications that alter the wound-healing response or evidence of compromised wound healing.
- The subject is known to have a history of keloid formation.
- The subject has a history of skin cancer or suspicious lesions in the treatment area.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wallace Skin and Body Institute
Los Angeles, California, 90056
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars
The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.
Read the detailed description
Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.
- Conditions
- Acne Scars
- Being tested
- Experimental: RF Device Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: RF Device ArmDevice
Non-invasive radiofrequency Alexandrite laser
| Study group | Role | What they receive |
|---|---|---|
| Alexandrite Laser | Experimental | Single arm, self-controlled Receives: Device: Experimental: RF Device Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic Evaluation of Changes in Treatment Areas
Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 90 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.
Measured: Baseline and 90 day follow up
Secondary outcomes (9)
Photographic Evaluation of Treatment Areas
Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 30 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.
Measured: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers.
Measured: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers.
Measured: Baseline and 90 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 30 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Measured: Baseline and 30 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 90 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Measured: Baseline and 90 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 30 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Measured: Baseline and 30 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 90 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Measured: Baseline and 90 day follow up
Subject satisfaction
Subject satisfaction rates at the 30 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.
Measured: 30 day follow up
Subject satisfaction
Subject satisfaction rates at the 90 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.
Measured: 90 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start8 Mar 2021
- Primary completion2 Aug 2024 (estimated)
- Study completion2 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807179
- Sponsor's protocol ID
- 7012-RGPL-2021
- Status last verified
- May 2024
- First submitted
- 11 Mar 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study To Evaluate The Efficacy And Safety Of An Alexandrite Laser Device For The Treatment Of Acne Scars
- ClinicalTrials.gov ID
- NCT04807179
- Acronym / sponsor ID
- 7012-RGPL-2021
- Conditions
- Acne Scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 2 Aug 2024 (estimated)
- Study completion
- 2 Aug 2024 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.
Detailed description
Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alexandrite Laser | Experimental | Device: Experimental: RF Device ArmSingle arm, self-controlled |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A healthy male or female 18 - 65 years of age.
- Has acne scars on the face (left, right, or front) and willing to undergo treatments with the study device.
- Is a skin type V or VI.
- 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.
Key exclusion criteria (19 listed)
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- The subject is hypersensitive to light in the near infrared wavelength region.
- The subject takes medication which is known to increase sensitivity to sunlight.
- The subject has seizure disorders triggered by light.
- The subject takes or has taken oral isotretinoin, such as Accutane®, within the last six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: RF Device ArmNon-invasive radiofrequency Alexandrite laser | Device | Alexandrite Laser |
Primary outcome
Photographic Evaluation of Changes in Treatment Areas
Time frame: Baseline and 90 day follow up
Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 90 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.
9 secondary outcomes
Photographic Evaluation of Treatment Areas
Time frame: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Time frame: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Time frame: Baseline and 90 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Time frame: Baseline and 30 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Time frame: Baseline and 90 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Time frame: Baseline and 30 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Time frame: Baseline and 90 day follow up
Subject satisfaction
Time frame: 30 day follow up
Subject satisfaction
Time frame: 90 day follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Civiok study director
Cynosure, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: RF Device Arm in people with Acne Scars, run by Cynosure, Inc. at 2 sites in United States.
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 6 inclusion and 19 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photographic Evaluation of Changes in Treatment Areas (time frame: Baseline and 90 day follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.