Combining Broad Based Light, Fractionated 1927 and Dual Wavelength 2940/1470 for Diffuse Pigmentation, Texture and Actinic Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
研究概览
简要总结
This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The study is designed to follow up to 15 consenting subjects who may receive up to 2 BBL/MOXI/HALO treatments under an IRB approved protocol.
详细描述
Subjects will receive 1-2 BBL/MOXI/HALO treatments. All 2nd treatments will be scheduled 4-8 weeks after the initial treatment to ensure the skin has enough time to recover. Overall assessments will be collected before the first treatment and at subsequent follow-up visits at 1 Month and 3 Months post final treatment. Identifiable full-face standard and close-up photography will be obtained and used to evaluate any changes. Subjects will also have photos obtained with the VISIA-CR Imaging System (Canfield Scientific, Parsippany, NJ). Quantitative analysis will be completed on the VISIA imaging system and be used to compare the effects of the treatments. Any improvements will be evaluated to pre-treatment assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
PI will assess subject after a single treatment and decide if a second treatment is necessary.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between 20-75 years of age
- •Fitzpatrick skin type 1-4
- •Individual deemed by the Investigator to benefit from skin resurfacing treatment(s)
- •Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study
- •Women of childbearing potential:
- •will be asked to agree to a pregnancy test before their screening visit in clinic 5.
- •must use an acceptable method of birth control
- •Hormonal contraception (oral, injected, implanted, patch or vaginal ring)
- •Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository
- •Intrauterine device (IUD)
- •Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
- •Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodical abstinence and withdrawal methods are not acceptable forms of contraception.
- •Individuals who can read, speak, write and understand English and who are willing to provide written informed consent.
- •Individuals willing to sign a photography release with the understanding that their photos may be used during presentations at national conferences and/or published in journals
- •Individuals willing and able to cooperate with all study requirements for the duration of the study.
排除标准
- •Fitzpatrick skin type V-VI
- •Known allergies to general skin care products
- •Sensitivity to topical local anesthetic
- •Current or recent history of skin diseases:
- •Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.)
- •Significant scars in the treatment area:
- •Severe or cystic and clinically significant acne or acne scars on the areas to be treated
- •Current or history of hypertrophic scarring or keloid scars
- •Tattoos in the area to be treated
- •Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator
- •Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated
- •Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, etc.
- •History of chronic drug or alcohol use
- •Recent aesthetic treatments:
- •<4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this treatment during the study
- •<2 weeks of any type of injectable filler
- •<1 week of neurotoxin's
- •<6 months of ablative resurfacing laser treatments
- •<6 months of non-ablative, rejuvenative laser or light treatment
- •<3 months of chemical peels or dermabrasion
- •Use of the following prescription medications:
- •<6 weeks of Accutane or other systemic retinoids on the treatment area
- •<4 weeks of topical retinoids
- •<4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin)
- •<2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract
- •Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use)
- •Psychiatric drugs that would impair the subject from understanding protocol requirements or understanding and signing the ICF.
- •Individuals who are pregnant or planning to become pregnant during the course of the study
- •Immunocompromised individuals or those currently using immunosuppressive medications and/or radiation
- •Individuals with uncontrolled disease such as asthma, diabetes, hyperthyroidism, medically significant hypertension, or hypothyroidism.
- •Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures planned during the course of the study.
- •Individuals who, in the Investigator's opinion, have a history of poor cooperation, unreliability or noncompliance with medical treatment.
- •Individuals who are unable to understand instructions or give informed consent
- •Individuals who have physical or psychological conditions which, in the opinion of the Investigator, makes them unable to complete the study per protocol.
研究组 & 干预措施
Single Treatment Arm
Subjects will receive a single treatment of BBL/MOXI/HALO
干预措施: Sciton Joule System (Device)
Double Treatment Arm
Subjects will receive double treatment of BBL/MOXI/HALO 4-6 weeks apart.
干预措施: Sciton Joule System (Device)
结局指标
主要结局
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Pores at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Pores at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Pores at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Pores at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Red Features at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Red Features at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Red Features at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Red Features at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall red features using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Texture at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Change in Texture at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Change in Texture at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Change in Texture at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall texture using measurements provided VISIA 3D analysis on different sides of the face for all subjects. Skin analysis is performed by the system to generate a numerical roughness count by providing a tally of the feature. A lower value signifies improvement. Minimum and Maximum value does not exist. The value is an Absolute Score derived from the integration of multiple topographical variables; because it measures the intensity of texture rather than a specific length or depth, it has no standard metric unit
Change in UV Spots at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in UV Spots at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in UV Spots at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in UV Spots at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall visible spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement
Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)
时间窗: Baseline, 1 Month
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)
时间窗: Baseline, 3 Months
Quantitively assessment of change in overall wrinkle are using measurements provided VISIA 3D analysis on different sides of the face for all subjects A lower value signifies improvement.
次要结局
未报告次要终点
研究者
Jeffrey M. Kenkel
Principle Investigator
University of Texas Southwestern Medical Center