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NCT Number: NCT05362929

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

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

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Key information

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic Hyperpigmentation Hypertrophy Laser-Induced Hyperpigmentation Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

555 Taxter Road

Elmsford, New York, 10523, United States

Location status: Recruiting

Location contact

Gabriela Gjini

CONTACT

[email protected]

914-457-4130

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Sciton Halo

Device

Laser treatment

Other names: Sciton hybrid fractional laser, hybrid fractional laser, Serial number: 88086862

Primary outcomes

  1. Change from baseline acne scar severity

    Time frame: month 3

    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.

  2. Change from baseline acne scar severity

    Time frame: month 5

    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.

  3. Change from baseline acne scar severity

    Time frame: month 8

    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.

  4. Baseline Patient Satisfaction

    Time frame: month 0 (patient consultation visit )

    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.

  5. Patient Satisfaction

    Time frame: throughout study completion, an average of 8 months

    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.

  6. Patient Satisfaction

    Time frame: month 3

    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.

  7. Patient Satisfaction

    Time frame: month 5

    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.

  8. Patient Satisfaction

    Time frame: month 8

    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.

  9. Dermatology Quality of Life Survey Baseline

    Time frame: month 0 (patient consultation visit)

    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."

  10. Dermatology Quality of Life Survey

    Time frame: throughout study completion, an average of 8 months

    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."

  11. Dermatology Quality of Life Survey

    Time frame: month 3

    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."

  12. Dermatology Quality of Life Survey

    Time frame: month 5

    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."

  13. Dermatology Quality of Life Survey

    Time frame: month 8

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Anika Jallorina, BS

CONTACT

[email protected]

618-704-8716

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 5, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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