NCT05105334Unknown不适用
Combined Treatment With Nonablative Fractional Laser and Radiofrequency Microneedling for the Treatment of Acne Scars: A Prospective, Randomized, Split-Face Study
Goldman, Butterwick, Fitzpatrick and Groff0 个研究点目标入组 20 人开始时间: 2021年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Change in atrophic acne scar
研究概览
简要总结
Compare the effectiveness of nonablative fractional resurfacing to radiofrequency micrnoeedling for facial acne scars in all skin types
详细描述
Quantify and compare the effectiveness of nonablative fractional laser (Fraxel re:store, Solta Medical, Bothell, WA) alone to nonablative fractional laser alternating with microneedling with radiofrequency (Intracel, Perigee Medical, Redwood City, CA) for the treatment of atrophic, facial acne scars in all skin types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical assessments and grading of severity of acne scarring will be performed by blinded-investigator assessment at each visit and at the post-treatment 3-month visit using live evaluations and photographs. At the 3-month follow up, three additional blinded dermatologists will clinically assess the severity of acne scarring.
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
- •Inclusion criteria
- •Male or female in general good health ages 18 and older
- •Fitzpatrick skin type I-VI
- •Subject has completed an appropriately administered informed consent process which includes signing the IRB approved consent form
- •Negative urine pregnancy test at baseline (if applicable)
- •Willingness to have facial exams and digital photos performed of the face
- •Moderate to severe atrophic acne scarring on the face per ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale
- •No change in estrogen releasing contraceptive method in 3 months, and no plans to change this contraceptive method during the course of the study
- •No change in topical skin care
- •Female patients will be either of non-childbearing potential defined as:
- •Having no uterus
- •No menses for at least 12 months. Or;
- •Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study, such as:
- •Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- •Intrauterine coil
- •Bilateral tubal ligation
- •Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- •Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
- •Vasectomized partner (Must agree to use barrier method described above (4) if becomes sexually active with non-vasectomized).
排除标准
- •Presence of incompletely healed wound in treatment area
- •Pregnant, planning pregnancy or breastfeeding during the course of the study
- •Energy-based device treatment in the treatment area in the last 6 months
- •Treatments with a dermal filler or biostimulatory agent in the treatment area within the past 12 months
- •Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks.
- •Individuals who have had a chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
- •Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) or the presence of suspected BCC or SCC in treatment area at investigator's discretion
- •Has skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
- •Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study (a list of the products with active and excipients will be provided below)
- •Individuals with active psoriasis, eczema, sunburn, excessive scarring, tattoos, or other skin condition on the face that would interfere with the assessments of this study
- •Subjects who participated on another study within the last 30 days
- •Subjects currently on or planning to participate in any type of research study at another facility or a doctor's office during this study
- •Subjects with a predisposition to keloid formation following surgery
- •Subjects on systemic steroids (e.g. prednisone, dexamethasone), or topical steroids on the face which should be rigorously avoided prior to and throughout the course of treatment
结局指标
主要结局
Change in atrophic acne scar
时间窗: 3 months after final treatment
The primary study endpoint will be clinical efficacy defined as change in atrophic acne scarring based on the ECCA grading scale and a 1-10 percentile scale.
次要结局
- Subject comfort level(To be done right after treatments)
- Subject satisfaction(3 months after final treatment)
- Subjective change(3 months after final treatment)
- Adverse events(3 months after final treatment)
研究者
相似试验
招募中
不适用
Effect of the Radiofrequency and Pelvic Muscle Training in the Treatment of Women with Vaginal Laxity.Sexual Dysfunction, PhysiologicalC12.294.644RBR-2zdvfpFaculdade de Ciência Médicas da Universidade Estadual de Campinas
进行中（未招募）
不适用
Study on Using Radiofrequency to Treat Moderate to Severe AcneModerate to Severe Acne VulgarisNCT06315166Pollogen30
招募中
3 期
Efficacy of Microneedle Fractional Radiofrequency combined with Topical Insulin for the treatment of facial atrophic acne scar: A split-face, double-blinded, randomized, placebo-controlled trialAcne scarAcne scar, topical insulin, microneedle fractional radiofrequencyTCTR20211203003Division of Dermatology, Ramathibodi Hospital, Mahidol University60
招募中
不适用
Efficacy of fractional Radiofrequency Microablation in the treatment of vaginal dryness, burning and itching of women with Breast Cancer: a randomized trialGenitourinary menopause syndromesexual dysfunctionN89.8F52.9breast cancermenopauseRBR-78mt53niversidade Estadual de Campinas
Unknown
不适用
Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic ScarsHypertrophic ScarsNCT04389619Cairo University30