CTRI/2023/04/052018已完成Unknown
Evaluation of comedogenicity potential of the investigational products by follicular biopsy test
Sami Sabinsa Group Ltd0 个研究点目标入组 13 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects 18 to 65 years of age.
- •2.Subjects must be generally in good health as determined by a recent medical history which is on file with the investigator.
- •3.The ability of the subject to understand and sign a written informed consent form which must be obtained before treatment.
- •4.Willingness to avoid the use of topical products at the test sites during the study.
- •5.Subjects known to have comedogenic skin. Subjects who are prone to acne and skin break-outs.
- •6.Presence of micro-comedomes at the screening visit.
排除标准
- •Subjects presenting and/or satisfying any of the following criteria will not be included in this study:
- •1.Individuals with an active or history of psoriasis, active allergic skin responses, or active eczema as determined by the initial paperwork. Individuals with a history of eczema will be allowed to the study, as long as they complete a supplemental consent form.
- •2.Individuals with sunburn, abrasions, scar tissue, or tattoos on the test sites, or diseases of the skin that might interfere with the evaluation made in this study or that expose study participants to unacceptable risks.
- •3.Women known to be pregnant, nursing, or planning to become pregnant during the study as determined by the initial paperwork.
- •4.Use of topical steroids and/or drugs at test sites as determined by the initial paperwork.
- •5.Current routine or frequent use of high doses of anti-inflammatory drugs for a defined medical condition as determined by medical history.
- •6.Individuals who had less than a two-week rest period since completion of any previous patch testing.
- •7.Individuals with uncontrolled metabolic diseases such as hypertension, hyperthyroidism, hypothyroidism, diabetes, etc.
- •8.Individuals who had a mastectomy in which axillary nodes were removed as determined by the initial paperwork.
- •9.Active or untreated skin cancer as determined by the initial paperwork.
- •10.Previous clinically determined allergic reaction or known sensitivities or allergies to personal care products of any type.
- •11.Individuals will be admitted to the study at the discretion of the Investigator based on medical history and findings of the pre-study interview and examination.
- •12.Subjects who are employed at CRO or with the sponsor
研究者
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