Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Baseline Patient Satisfaction
研究概览
简要总结
The investigators aim to investigate the efficacy and tolerability of a hybrid non-ablative/ablative laser for acne scarring in skin of color.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sciton Halo (Device)
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.
干预措施: Sciton Halo (Device)
结局指标
主要结局
Baseline Patient Satisfaction
时间窗: 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.
Change from baseline acne scar severity
时间窗: 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.
Dermatology Quality of Life Survey Baseline
时间窗: 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."
Patient Satisfaction
时间窗: 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.
Dermatology Quality of Life Survey
时间窗: 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."
Change in Acne Scar Severity
时间窗: Baseline to Month 9
Change in acne scarring severity from baseline to nine months will be assessed using the Global Scale for Acne Scar Severity (SCAR-S) scale. The SCAR-S is a validated scale used to assess the severity of acne scarring using a 6-point scale ranging from 0 ("Clear, no visible scars from acne") to 5 ("Very Severe; entire area with prominent atrophic or hypertrophic scars") such that higher scores are indicative of more severe scarring. Two independent blinded dermatologists will rate before and after treatment images using the SCAR-S scale. Results will be summarized by study arm using descriptive statistics.
Change in Clinician Graded Global Assessment of Improvement Scale (GAIS) score
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Change in aesthetic success from baseline will be evaluated using the Clinician's Global Assessment of Improvement Scale (CGAIS). The CGAIS evaluates overall efficacy and cosmetic outcomes of the treatment. The CGAIS is based upon a 7-point scale ranging from -3 ("Greatly worsened") to +3 ("Greatly improved"), with 0 ("No change") as the midpoint. Two independent unbiased blinded dermatologists will conduct live/photographic assessments to evaluate patients at baseline, Month 2, Month 3, Month 4, Month 6, and Month 9. Results will be summarized by study arm using descriptive statistics.
Overall Patient Satisfaction
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Overall patient satisfaction will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in how their skin looks using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Acne Scarring
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of acne scarring will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in acne scarring in the area treated using a 7-point scale ranging from -3 ("Greatly decreased") to +3 ("Greatly increased"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Skin Texture
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of skin texture will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin texture using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of Skin Pigmentation
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of skin pigmentation will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients to select the option that better represents the change in their skin pigmentation using a 7-point scale ranging from -3 ("Greatly improved") to +3 ("Greatly worsened"), with 0 ("No change") as the midpoint. Scores will be summarized by study arm using descriptive statistics.
Patient Assessment of General Skin Changes - Binary
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient assessment of general skin changes will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients "beyond texture, pigmentation, and overall acne scarring, did you notice any other changes in the area that was treated." Patients will select either "Yes" or "No." Binary responses will be summarized by study arm.
Patient Assessment of General Skin Changes - Categorical
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients who confirmed that they did notice changes in the "Patient Assessment of General Skin Changes - Binary" query on the PSQ will be asked to specify what those changes were from a menu of options. These options are "Pores are smaller," "Skin is less oily," "Skin is smoother," "Skin feels better," "Skin looks more radiant," "Face feels more youthful," and "Other." Patients will have the option of selecting more than one response. Responses will be categorically summarized by study arm.
Patient Satisfaction with Treatment
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patient satisfaction with treatment will be assessed throughout the study using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. This question asks patients how they would characterize their satisfaction with the treatment using the following suite of options: "Very dissatisfied," "Dissatisfied," "Slightly dissatisfied," "Neither Satisfied or Dissatisfied," "Slightly satisfied," "Satisfied," or "Very Satisfied." Ordinal responses will be summarized by study arm using descriptive statistics.
Recommend Treatment to Family and Friends
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they would recommend the treatment to friends and family members using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of recommendations to family/friends will be summarized by study arm.
Patient adherence to skin care accommodations for laser treatment
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are following skin care accommodations for laser treatment using an item from the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of adherence to skin care accommodations for laser treatment will be summarized by study arm.
Daily mineral sunscreen use
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are using daily mineral sunscreen of SPF30 or greater on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of usage will be summarized by study arm.
Sun avoidance
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
Patients will be asked whether they are avoiding the sun on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Binary ("Yes" or "No") responses of sun avoidance will be summarized by study arm.
Treatment-related Side Effects
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
One of the safety variables will be treatment-related side effects. Patients will be asked whether they are experienced any of the following side effects following laser treatment: "Erythema," "Prolonged erythema," "Acne flare up," "Hypopigmentation," and "Hyperpigmentation." on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients can select any/all treatment-related side effects which they experienced. Responses will be categorically summarized by study arm.
Pain Discomfort
时间窗: Baseline to Month 2, Month 3, Month 4, Month 6, and Month 9
One of the safety variables will be pain discomfort. Patients will be asked to quantify the degree of pain discomfort experienced following treatment using a pain scale item provided on the Patient Satisfaction Questionnaire (PSQ) completed during each visit. Patients will rate their pain discomfort on an 11-point Likert scale ranging from 0 ("No Pain") to 10 ("Worst Possible Pain"), such that higher scores are indicative of increased pain discomfort. Results will be summarized by study arm using descriptive statistics.
次要结局
未报告次要终点