Clinical trial NCT05362929: Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Official title: Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-institution, baseline-controlled, prospective comparative study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline acne scar severity
timeFrame: month 3
measure: Change from baseline acne scar severity
timeFrame: month 5
measure: Change from baseline acne scar severity
timeFrame: month 8
measure: Baseline Patient Satisfaction
timeFrame: month 0 (patient consultation visit )
measure: Patient Satisfaction
timeFrame: throughout study completion, an average of 8 months
measure: Patient Satisfaction
timeFrame: month 3
measure: Patient Satisfaction
timeFrame: month 5
measure: Patient Satisfaction
timeFrame: month 8
measure: Dermatology Quality of Life Survey Baseline
timeFrame: month 0 (patient consultation visit)
measure: Dermatology Quality of Life Survey
timeFrame: throughout study completion, an average of 8 months
measure: Dermatology Quality of Life Survey
timeFrame: month 3
measure: Dermatology Quality of Life Survey
timeFrame: month 5
measure: Dermatology Quality of Life Survey
timeFrame: month 8
Secondary outcomes:
Other outcomes:
Locations:
city: Elmsford
country: United States
facility: 555 Taxter Road
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Kseniya Kobets, MD
role: PRINCIPAL_INVESTIGATOR
References: