Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color

NCT05362929 | Recruiting DMC FDA Device

• 1 other identifier: 2022-14024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (13)

• Change from baseline acne scar severity

  2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

  month 3

• Change from baseline acne scar severity

  2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

  month 5

• Change from baseline acne scar severity

  2 Independent unbiased blinded dermatologists will rate before and after treatment images using Global Scale for Acne Scarring. This scale is rated on a scale of 0 to 5. 0 is the least severe, and 5 is the most severe.

  month 8

• Baseline Patient Satisfaction

  Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

  month 0 (patient consultation visit )

• Patient Satisfaction

  Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

  throughout study completion, an average of 8 months

• Patient Satisfaction

  Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

  month 3

• Patient Satisfaction

  Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

  month 5

• Patient Satisfaction

  Patient Satisfaction Questionnaire. Questions are on a scale of -3 to 3, with -3 meaning the condition greatly decreased, and 3 meaning the condition greatly increased.

  month 8

• Dermatology Quality of Life Survey Baseline

  Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."

  month 0 (patient consultation visit)

• Dermatology Quality of Life Survey

  Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."

  throughout study completion, an average of 8 months

• Dermatology Quality of Life Survey

  Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."

  month 3

• Dermatology Quality of Life Survey

  Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."

  month 5

• Dermatology Quality of Life Survey

  Dermatology Life Quality Index. This is a standardized dermatology scale. Questions are subjectively answered by participants with answer choices ranging from "very much, a lot, a little, and not at all."

  month 8

Study Arms (2)

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.

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.

Device: Sciton Halo

Interventions

Sciton Halo DEVICE

Laser treatment

Also known as: Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862

Hybrid Fractional laser - SOC; Hybrid Fractional laser- Non- SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

555 Taxter Road

Elmsford, New York, 10523, United States

RECRUITING

MeSH Terms

Conditions

Hypertrophy; Hyperpigmentation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kseniya Kobets, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anika Jallorina, BS

CONTACT

618-704-8716; ajallorina@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Images of deidentified participants before and after treatment will be presented by two independent, non biased, blinded, board certified dermatologists for rating of improvement and outcome scores.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-institution, baseline-controlled, prospective comparative study

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: May 5, 2022
• Study Start: October 11, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)