A Randomized, Single-Center, Double-Blinded, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Radiofrequency Microneedling for Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging. Furthermore, this clinical trial will compare the active post-procedure cream to a comparator anhydrous cream product often paired with skin rejuvenation procedures.
A total of 11 healthy female subjects completed the study. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
详细描述
This randomized, single-center, double-blinded, controlled, clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after radiofrequency microneedling and for seven days post-procedure with twice daily application in healthy female subjects ages 35-65 with moderate facial photodamage (Grade II or III) using the Glogau Scale of Photoaging in improving patient downtime specifically in minimizing tolerability parameters (erythema, edema, dryness, burning, stinging, and itch) to assist in soothing skin after radiofrequency microneedling procedure.
A 7-day washout period is required for all subjects prior to radiofrequency microneedling procedure. Tolerability (investigator and subject) and safety will be assessed through grading at baseline, post-procedure, post-procedure/post-product application, twenty-four (24) hours post-procedure, three days post-procedure, and seven days post-procedure.
Tolerability parameters included erythema, edema, dryness, burning, stinging, and itch. Efficacy evaluation using the Glogau photoaging scale was performed at screening, baseline, and day 7 post-procedure. The Global Aesthetic Improvement Scale (GAIS) was performed at day 7-post procedure. Self-assessment questionnaire and clinical photography will be completed at all timepoints.
A total of 11 subjects completed study participation. Six (6) subjects in the active arm and five (5) subjects in the comparator arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects will be randomly assigned to one of the following treatment arms: active post-procedure cream versus comparator anhydrous cream. The products will be packaged in the same container and labelled post-procedure cream. Double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety are blinded to treatment during the 14-day randomization study.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects must be between 35-65 years of age.
- •Female subjects of childbearing potential must be willing to use a form of birth control during the study.
- •Subjects with Fitzpatrick I-VI photo skin type.
- •Subjects must have moderate photodamage (Grade II or III) using the Glogau Scale of Photoaging.
- •6. Subjects interested in Radiofrequency Microneedling treatments.
- •Subjects must have no skin disease in the facial area being evaluated.
- •Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects must be wiling to discontinue all active topical facial products and must only use the assigned study products to the face and neck for the duration of the study.
排除标准
- •Subjects being or planning to become pregnant or breastfeeding during the study
- •Having received a chemical peel, dermabrasion or microneedling treatment in the previous six months; laser resurfacing (ablative, non-ablative) in the previous twelve months
- •Unwilling to refrain from pain medications post-procedure
- •Unwilling to discontinue topical anti-aging facial products for one week prior to study commencement or on prescription strength retinoids or skin lightening produces within two months of the study.
- •Subjects who have a Glogau Score of I or IV.
结局指标
主要结局
Incidence of Adverse Events
时间窗: 14-days
The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediate post-procedure and through-out the length of the study.
Investigator Tolerability Scores
时间窗: 14 days
The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe
Subject Tolerability Scores
时间窗: 14 days
Subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in scores or lack of significant change after procedure, immediately post-procedure, post product application, Day 1 (24 hours), Day 3, and Day 7 in comparison to baseline (post-procedure) indicates tolerability / safety of the test material. Four-point scale with a lower score indicating a better outcome. 0 = None 1. = Mild 2. = Moderate 3. = Severe
次要结局
- Self-Assessment Questionnaire(14 days)
- Clinical Efficacy Grading(14 days)