A Novel Regimen for Treatment and Prevention of Post-Inflammatory Hyperpigmentation in Skin of Color
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from baseline to week 12 of patient satisfaction in improvement of post-inflammatory hyperpigmentation
研究概览
简要总结
This is a single-center, prospective, non-blinded, non-randomized 12 week clinical study to evaluate the efficacy of a SkinCeuticals comprehensive skin care regimen in the reduction of post inflammatory hyperpigmentation (PIH) in skin of color patients. The comprehensive regimen features the Pigment Balancing Peel which combines glycolic acid, lactic acid, kojic acid, vitamin C, and emblica into a treatment that may improve skin discoloration. Participants will supplement the Pigment Balancing Peel with a 11 week regimen that includes the Hydrating B5 Gel, Discoloration Defense, LHA Cleansing Gel, and Brightening UV Defense sunscreen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18+.
- •Clinical diagnosis of Post Inflammatory Hyperpigmentation
- •Non-Caucasian
- •Fitzpatrick skin types IV-VI
- •Available and willing to comply with study instructions and attend all study visits.
- •Able and willing to provide written and verbal informed consent.
排除标准
- •Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- •Caucasian/ Non-Hispanic
- •Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •Pregnant, lactating, or is planning to become pregnant during the study.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- •Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.
- •Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- •Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- •Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
结局指标
主要结局
Change from baseline to week 12 of patient satisfaction in improvement of post-inflammatory hyperpigmentation
时间窗: From enrollment to end of treatment at 12 weeks
Change in the patient satisfaction with their physical appearance following use of SkinCeuticals regimen to improve post inflammatory hyperpigmentation, using the FACE-Q Satisfaction (scores range from 0 (lowest) to 100 (highest)), at week 12 compared to baseline.
次要结局
- Change in DLQI at baseline vs week 12(From enrollment to end of treatment at 12 weeks)
- Change in the melanin and erythema index at baseline, week 6, and week 12(From enrollment to end of treatment at 12 weeks)
- Change in psychosocial factors utilizing the FACE-Q Social Function Scale following treatment at baseline vs week 12(From enrollment to end of treatment at 12 weeks)
- Patient expectations utilizing FACE-Q Expectations Scale(From enrollment to end of treatment at 12 weeks)
- Change in psychosocial factors utilizing the FACE-Q Psychological Function Scale following treatment at baseline vs week 12(From enrollment to end of treatment at 12 weeks)
- Patient satisfaction with treatment using FACE-Q outcome scale at week 12(From enrollment to end of treatment at 12 weeks)