Recruiting

Hybrid Fractional Laser

Sponsor:

Montefiore Medical Center

Code:

NCT05362929

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Hyperpigmentation

Laser-Induced Hyperpigmentation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sciton Halo

Study Details

Brief summary:

The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Hyperpigmentation

Laser-Induced Hyperpigmentation

Study ID

NCT05362929

Start date

Oct 11, 2023

Status verified date

Aug, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hybrid Fractional laser - SOC

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.

experimental: Hybrid Fractional laser- Non- SOC

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.

Interventions

Sciton Halo

Laser treatment

Primary outcome measure

  • Change in Acne Scar Severity [ Time Frame: Baseline to Month 9 ]
  • 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 ]
  • Overall Patient Satisfaction [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Patient Assessment of Acne Scarring [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Patient Assessment of Skin Texture [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Patient Assessment of Skin Pigmentation [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • 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 - Categorical [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Patient Satisfaction with Treatment [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Recommend Treatment to Family and Friends [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Patient adherence to skin care accommodations for laser treatment [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Daily mineral sunscreen use [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Sun avoidance [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Treatment-related Side Effects [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]
  • Pain Discomfort [ Time Frame: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9 ]

Central Contacts and Locations

Central contacts

Anika Jallorina, BS

618-704-8716ajallorina@montefiore.org

Locations

555 Taxter Road

Recruiting

Elmsford, New York, United States, 10523

Contacts

Gabriela Gjini

914-457-4130ggjini@montefiore.org

More Information

Sponsor

Montefiore Medical Center

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • skin of color
  • fitzpatrick skin type III
  • fitzpatrick skin type IV
  • fitzpatrick skin type V
  • acne scarring
  • sciton

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-08-11.