Acne Scars - Mixed Atrophic and HypertrophicNCT05362929
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
A study testing Sciton Halo in people with Acne Scars - Mixed Atrophic and Hypertrophic and Hyperpigmentation, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color. 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 - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
- What is being tested?
- Sciton Halo
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of acne scarring recorded over the past 6 months
- Able to read, understand and voluntarily provide written informed consent.
- Subject is determined to be healthy, non-smoker
- Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Who cannot join
- Subjects does not have the capacity to consent to the study
- Subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study
- Subject has active papulopustular or cystic acne within the past 6 months
- Any history of keloidal scarring
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months
- History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy for prior 12 months
Show all 15Show fewer
- Subject has no health contraindications to receiving local lidocaine and epinephrine injections, including but not limited to any form of heart disease or arrhythmia, untreated or uncontrolled severe hypertension, uncontrolled hyperthyroidism, uncontrolled diabetes, pheochromocytoma, cocaine use
- History or current use of the following prescription medications:
- Immunosuppressive medications/biologics, 6 months prior to and during the study.
- Accutane or other systemic retinoids within the past twelve months TCA, MAO, or beta-blockers
- Smoking or vaping in the past 12 months
- History of photosensitivity and/or connective tissue disease
- History of hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders
- History of major depressive disorders or endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism
- History of ongoing pregnancy, active breastfeeding, cancer, and epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
555 Taxter Road
Elmsford, New York, 10523
Gabriela Gjini, 914-457-4130, ggjini@montefiore.org
About this study
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Read the detailed description
Acne is chronic inflammatory condition involving the pilosebaceous unit. One of the most common complications of acne is scarring, which occurs as a result of dermal damage during the healing process of active acne. Studies have shown that acne scarring can have a negative impact on an individual's quality of life and has been described as a risk factor for multiple psychiatric conditions including depression, anxiety, suicide, and poor self-esteem. Unfortunately, treatment of acne scarring, particularly those of the atrophic subtype, prove difficult to treat. A 2016 Cochrane review failed to provide sufficient evidence to support the first-line use of any intervention. Laser technology has been emerging as an effective, non-invasive treatment of acne scarring. Ablative lasers work by delivering energy to the dermal layer of the skin, resulting in thermal injury and stimulation of dermal cells to produce collagen, thus resolving the scar. More recently, fractional lasers, which create multiple tiny columns of thermal injury, have been introduced with the benefit of reduced downtime and adverse effects compared to ablative lasers. The fractional CO2 laser is widely used for the treatment of acne scarring, however its use is limited in patients of Fitzpatrick IV and V skin due to risk of hyperpigmentation among other adverse events. The erbium-YAG fractional laser serves as an alternative, and has shown to produce less thermal injury and thus be more well-tolerated with lower risk of adverse effects in patients. The hybrid fractional laser combines a 2940 nm wavelength with a 1470 wavelength and has an ablative component targeting the epidermis and a nonablative component targeting the dermis at the same spot. The investigators seek to investigate the Sciton Halo, hybrid fractional laser for its efficacy in treating acne scarring and tolerability in patients with a specific emphasis on those with Fitzpatrick IV and V skin.
- Conditions
- Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
- Being tested
- Sciton Halo
- Keywords
- skin of color, fitzpatrick skin type III, fitzpatrick skin type IV, fitzpatrick skin type V, acne scarring, sciton
- Medical subject headings
- Hypertrophy, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciton HaloDevice
Also called Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862
Laser treatment
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Fractional laser - SOC | Experimental | 23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey. Receives: Device: Sciton Halo |
| Hybrid Fractional laser- Non- SOC | Experimental | 23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey. Receives: Device: Sciton Halo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acne Scar Severity
Change in acne scarring severity from baseline to nine months will be assessed using the Global Scale for Acne Scar Severity (SCAR-S) scale. The SCAR-S is a validated scale used to assess the severity of acne scarring using a 6-point scale ranging from 0 ("Clear, no visible scars from acne") to 5 ("Very Severe; entire area with prominent atrophic or hypertrophic scars") such that higher scores are indicative of more severe scarring. Two independent blinded dermatologists will rate before and after treatment images using the SCAR-S scale. Results will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 9
Change in Clinician Graded Global Assessment of Improvement Scale (GAIS) score
Change in aesthetic success from baseline will be evaluated using the Clinician's Global Assessment of Improvement Scale (CGAIS). The CGAIS evaluates overall efficacy and cosmetic outcomes of the treatment. The CGAIS is based upon a 7-point scale ranging from -3 ("Greatly worsened") to +3 ("Greatly improved"), with 0 ("No change") as the midpoint. Two independent unbiased blinded dermatologists will conduct live/photographic assessments to evaluate patients at baseline, Month 2, Month 3, Month 4, Month 6, and Month 9. Results will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Overall Patient Satisfaction
Overall patient satisfaction will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in how their skin looks using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Assessment of Acne Scarring
Patient assessment of acne scarring will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in acne scarring in the area treated using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Assessment of Skin Texture
Patient assessment of skin texture will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin texture using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Assessment of Skin Pigmentation
Patient assessment of skin pigmentation will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin pigmentation using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Assessment of General Skin Changes - Binary
Patient assessment of general skin changes will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients "beyond texture, pigmentation, and overall acne scarring, did you notice any other changes in the area that was treated." Patients will select either "Yes" or "No." Binary responses will be summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Assessment of General Skin Changes - Categorical
Patients who confirmed that they did notice changes in the "Patient Assessment of General Skin Changes - Binary" query on the PSQ will be asked to specify what those changes were from a menu of options. These options are "Pores are smaller," "Skin is less oily," "Skin is smoother," "Skin feels better," "Skin looks more radiant," "Face feels more youthful," and "Other." Patients will have the option of selecting more than one response. Responses will be categorically summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient Satisfaction with Treatment
Patient satisfaction with treatment will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients how they would characterize their satisfaction with the treatment using the following suite of options: "Very dissatisfied," "Dissatisfied," "Slightly dissatisfied," "Neither Satisfied or Dissatisfied," "Slightly satisfied," "Satisfied," or "Very Satisfied." Ordinal responses will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Recommend Treatment to Family and Friends
Patients will be asked whether they would recommend the treatment to friends and family members using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of recommendations to family/friends will be summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient adherence to skin care accommodations for laser treatment
Patients will be asked whether they are following skin care accommodations for laser treatment using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of adherence to skin care accommodations for laser treatment will be summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Daily mineral sunscreen use
Patients will be asked whether they are using daily mineral sunscreen of SPF30 or greater on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of usage will be summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Sun avoidance
Patients will be asked whether they are avoiding the sun on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of sun avoidance will be summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Treatment-related Side Effects
One of the safety variables will be treatment-related side effects. Patients will be asked whether they are experienced any of the following side effects following laser treatment: "Erythema," "Prolonged erythema," "Acne flare up," "Hypopigmentation," and "Hyperpigmentation." on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients can select any/all treatment-related side effects which they experienced. Responses will be categorically summarized by study arm.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Pain Discomfort
One of the safety variables will be pain discomfort. Patients will be asked to quantify the degree of pain discomfort experienced following treatment using a pain scale item provided on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients will rate their pain discomfort on an 11-point Likert scale ranging from 0 ("No Pain") to 10 ("Worst Possible Pain"), such that higher scores are indicative of increased pain discomfort. Results will be summarized by study arm using descriptive statistics.
Measured: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start11 Oct 2023
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a single-institution, baseline-controlled, prospective comparative study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sciton
- Responsible party
- Sponsor
- Investigators
- Kseniya Kobets, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362929
- Sponsor's protocol ID
- 2022-14024
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will not be available to researchers not part of the original research team. All patient data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
- ClinicalTrials.gov ID
- NCT05362929
- Acronym / sponsor ID
- 2022-14024
- Conditions
- Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation, Laser-Induced Hyperpigmentation
- Keywords
- skin of color, fitzpatrick skin type III, fitzpatrick skin type IV, fitzpatrick skin type V, acne scarring, sciton
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Sciton
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 5 May 2022 (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 investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
Detailed description
Acne is chronic inflammatory condition involving the pilosebaceous unit. One of the most common complications of acne is scarring, which occurs as a result of dermal damage during the healing process of active acne. Studies have shown that acne scarring can have a negative impact on an individual's quality of life and has been described as a risk factor for multiple psychiatric conditions including depression, anxiety, suicide, and poor self-esteem. Unfortunately, treatment of acne scarring, particularly those of the atrophic subtype, prove difficult to treat. A 2016 Cochrane review failed to provide sufficient evidence to support the first-line use of any intervention. Laser technology has been emerging as an effective, non-invasive treatment of acne scarring. Ablative lasers work by delivering energy to the dermal layer of the skin, resulting in thermal injury and stimulation of dermal cells to produce collagen, thus resolving the scar. More recently, fractional lasers, which create multiple tiny columns of thermal injury, have been introduced with the benefit of reduced downtime and adverse effects compared to ablative lasers. The fractional CO2 laser is widely used for the treatment of acne scarring, however its use is limited in patients of Fitzpatrick IV and V skin due to risk of hyperpigmentation among other adverse events. The erbium-YAG fractional laser serves as an alternative, and has shown to produce less thermal injury and thus be more well-tolerated with lower risk of adverse effects in patients. The hybrid fractional laser combines a 2940 nm wavelength with a 1470 wavelength and has an ablative component targeting the epidermis and a nonablative component targeting the dermis at the same spot. The investigators seek to investigate the Sciton Halo, hybrid fractional laser for its efficacy in treating acne scarring and tolerability in patients with a specific emphasis on those with Fitzpatrick IV and V skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-institution, baseline-controlled, prospective comparative study
| Arm | Type | Receives |
|---|---|---|
| Hybrid Fractional laser - SOC | Experimental | Device: Sciton Halo23 participants with fitzpatrick skin type IV-V will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey. |
| Hybrid Fractional laser- Non- SOC | Experimental | Device: Sciton Halo23 participants with Fitzpatrick skin type I-III will be in this arm. At the first visit, participants will undergo informed consent, education about the procedure, education about proper sun-care, and will be provided sunscreen. Participants will be prescribed a prescription of hydroquinone or a retinol to prevent hyperpigmentation, per standard of care. If participants choose to take this they will wait one month of taking the prescription and then begin treatment sessions. If not, participants can begin treatment sessions right away. Treatment consists of 3 laser sessions with the Sciton Halo hybrid fractional laser. Session amount depends on the degree of improvement. At each session before and after images will be collected. At each session participants will fill out the dermatology quality of life survey as well as a patient satisfaction survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for acne scarring
- Subject must voluntarily sign and date an IRB approved informed consent form
- Subjects with diagnosis of acne scarring recorded over the past 6 months
- Able to read, understand and voluntarily provide written informed consent.
- Subject is determined to be healthy, non-smoker
Key exclusion criteria (15 listed)
- Subjects does not have the capacity to consent to the study
- Subject underwent any acne scar treatments in the past 6 months prior to enrollment in the study
- Subject has active papulopustular or cystic acne within the past 6 months
- Any history of keloidal scarring
- Any previous surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 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 |
|---|---|---|
| Sciton HaloAlso: Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862Laser treatment | Device | Hybrid Fractional laser - SOC, Hybrid Fractional laser- Non- SOC |
Primary outcome
Change in Acne Scar Severity
Time frame: Baseline to Month 9
Change in acne scarring severity from baseline to nine months will be assessed using the Global Scale for Acne Scar Severity (SCAR-S) scale. The SCAR-S is a validated scale used to assess the severity of acne scarring using a 6-point scale ranging from 0 ("Clear, no visible scars from acne") to 5 ("Very Severe; entire area with prominent atrophic or hypertrophic scars") such that higher scores are indicative of more severe scarring. Two independent blinded dermatologists will rate before and after treatment images using the SCAR-S scale. Results will be summarized by study arm using descriptive statistics.
Change in Clinician Graded Global Assessment of Improvement Scale (GAIS) score
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Change in aesthetic success from baseline will be evaluated using the Clinician's Global Assessment of Improvement Scale (CGAIS). The CGAIS evaluates overall efficacy and cosmetic outcomes of the treatment. The CGAIS is based upon a 7-point scale ranging from -3 ("Greatly worsened") to +3 ("Greatly improved"), with 0 ("No change") as the midpoint. Two independent unbiased blinded dermatologists will conduct live/photographic assessments to evaluate patients at baseline, Month 2, Month 3, Month 4, Month 6, and Month 9. Results will be summarized by study arm using descriptive statistics.
Overall Patient Satisfaction
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Overall patient satisfaction will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in how their skin looks using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Acne Scarring
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of acne scarring will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in acne scarring in the area treated using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Skin Texture
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of skin texture will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin texture using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Skin Pigmentation
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of skin pigmentation will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin pigmentation using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of General Skin Changes - Binary
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of general skin changes will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients "beyond texture, pigmentation, and overall acne scarring, did you notice any other changes in the area that was treated." Patients will select either "Yes" or "No." Binary responses will be summarized by study arm.
Patient Assessment of General Skin Changes - Categorical
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients who confirmed that they did notice changes in the "Patient Assessment of General Skin Changes - Binary" query on the PSQ will be asked to specify what those changes were from a menu of options. These options are "Pores are smaller," "Skin is less oily," "Skin is smoother," "Skin feels better," "Skin looks more radiant," "Face feels more youthful," and "Other." Patients will have the option of selecting more than one response. Responses will be categorically summarized by study arm.
Patient Satisfaction with Treatment
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient satisfaction with treatment will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients how they would characterize their satisfaction with the treatment using the following suite of options: "Very dissatisfied," "Dissatisfied," "Slightly dissatisfied," "Neither Satisfied or Dissatisfied," "Slightly satisfied," "Satisfied," or "Very Satisfied." Ordinal responses will be summarized by study arm using descriptive statistics.
Recommend Treatment to Family and Friends
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they would recommend the treatment to friends and family members using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of recommendations to family/friends will be summarized by study arm.
Patient adherence to skin care accommodations for laser treatment
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are following skin care accommodations for laser treatment using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of adherence to skin care accommodations for laser treatment will be summarized by study arm.
Daily mineral sunscreen use
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are using daily mineral sunscreen of SPF30 or greater on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of usage will be summarized by study arm.
Sun avoidance
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are avoiding the sun on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of sun avoidance will be summarized by study arm.
Treatment-related Side Effects
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
One of the safety variables will be treatment-related side effects. Patients will be asked whether they are experienced any of the following side effects following laser treatment: "Erythema," "Prolonged erythema," "Acne flare up," "Hypopigmentation," and "Hyperpigmentation." on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients can select any/all treatment-related side effects which they experienced. Responses will be categorically summarized by study arm.
Pain Discomfort
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
One of the safety variables will be pain discomfort. Patients will be asked to quantify the degree of pain discomfort experienced following treatment using a pain scale item provided on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients will rate their pain discomfort on an 11-point Likert scale ranging from 0 ("No Pain") to 10 ("Worst Possible Pain"), such that higher scores are indicative of increased pain discomfort. Results will be summarized by study arm using descriptive statistics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data will not be available to researchers not part of the original research team. All patient data will be de-identified.
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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.
Kseniya Kobets, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciton Halo in people with Acne Scars - Mixed Atrophic and Hypertrophic and Hyperpigmentation, run by Montefiore Medical Center at 1 site 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Chan, BA (631-553-2203, ryachan@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acne Scar Severity (time frame: Baseline to Month 9). The study lists 15 primary outcomes in all. 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 1 Oct 2026.