A Comparative Clinical Study to evaluate the Skin Dryness and Soothing Effects of Benzoyl Peroxide Versus Polymer-Based Benzoyl Peroxide Formulations in Acne Treatment
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
This study will be conducted as a comparative, split-face clinical study.
Each participant entering the trial will be assigned to a regimen of the investigational product in a split-face manner, wherein one side of the face (left or right) will receive the test product and the contralateral side will receive the comparator.
Assessments
All assessments listed in the study design will be performed separately on each side of the face at the defined time points.
Instrumental Assessments:
•Skin Hydration (Corneometer): (0, 30min, 4hr, 8hr, 24hr and 14 day)
•TEWL (Tewameter): (0, 30min, 24hr, 14 day)
•Skin Sebum (Sebumeter): (0, 14 day)
•Acne Count by Visio scan: (0, 14 day)
Dermatological Evaluations (5-Point Ordinal Scale):
•Smooth Skin
•Calm Skin
•Skin Roughness
Imaging Assessment:
•High-Definition Facial Imaging using DSLR camera
30-Minute Post-Application Assessment- At 30 minutes post first application, immediate effects of the product will be assessed on each facial side for:
•Skin Hydration (Corneometer)
•TEWL (Tewameter)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
入选标准
- •1.Gender: Male and Female(50:50) aged Between 18-
- •2.Non-pregnant, non-lactating female 3.Subject with acne and normal to oily skin.
- •4.Subject willing to give written informed consent 5.Women of child bearing potential must have a negative urine pregnancy test.
- •6.Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •7.Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study 2.Subjects having Moderate to severe pigmentation, sunburn, scar or any type of skin concern.
- •3.Volunteers with skin conditions such as eczema, psoriasis, etc 4.Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •5.Have open sore or open lesions in the treatment area
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •7.Have participated in any interventional clinical trial in the previous 30 days.
- •8.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •9.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
- •10.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
研究者
Dr Robin Chugh
CCFT Laboratories