An interventional study of Sciton Halo in Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation and Laser-Induced Hyperpigmentation, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
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.
139 studies on the registry are indexed under Hypertrophy; 22 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 112 interventional studies indexed under Hypertrophy.
Browse Hypertrophy studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Sciton Halo
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.
Device: Sciton Halo
Laser treatment
Also known as: Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Dermatology Quality of Life
Dermatology quality of life will be assessed using the Dermatology Life Quality Index (DLQI). The DLQI is a standardized 10-item dermatology scale which determines how much impact a skin condition has had on life quality. Patients are asked to consider how much their skin problem has affected their life over the prior week when responding to each question. Questions are subjectively answered by patients using the following choices: "Very much" (= 3 points), "A lot" (= 2 points), "A little" (= 1 point), and "Not at all" or "Not relevant" (= 0 points). Scores are summarized for an overall possible range of 0-30, such that higher scores are indicative of greater dermatology-related life quality impairment. Results will be summarized by study arm using descriptive statistics.
Time frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Jul 2029, 69 months after the start.
Of 65 non-industry interventional studies with no phase under Hypertrophy, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 22. This study's planned 69 months is above that.
Counting every sponsor, half of 78 studies reached it within 13 months; a quarter within 6 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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