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

Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362929
• Other study ID #: 2022-14024
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Albert Einstein College of Medicine
• Contact: Janet Choi, BS
• Phone: (917)680-9907
• Email: janet.choi[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Hyperpigmentation
• Laser-Induced Hyperpigmentation

Intervention

Device:
• Sciton Halo
Laser treatment

Locations

Country	Name	City	State
United States	555 Taxter Road	Elmsford	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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 )
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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