CTRI/2021/03/032229已完成未知
Evaluation of dermatological safety of twenty investigational products by a 24-hour patch test to assessthe irritation potential on healthy volunteers
Vasu Research Centre A division of Vasu Healthcare Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Healthy male and female volunteers aged 18 to 65 with no active
- •dermatological conditions
- •2. Good general and mental health with, in the opinion of the
- •investigator or medically qualified designee with no clinically
- •significant and relevant abnormalities in medical history or upon
- •physical examination
- •3. Subjects who have intact skin on the proposed application site;
- •dorsum (scapular region)
- •4. Fitzpatrick phototype I to IV skin type
- •5. Willingness to participate as evidenced by voluntary written
- •informed consent
排除标准
- •1. Women who are known to be pregnant or who are intending to
- •become pregnant over the duration of the study
- •2. Women who are breast-feeding
- •3. Any history of significant dermatological diseases or conditions or
- •medical conditions known to alter skin appearance or physiologic
- •response (e.g. diabetes,) which could, in the opinion of the
- •Investigator, preclude topical application of the investigational
- •products and/or interfere with the evaluation of the test site reaction.
- •4. Presence of open sores, pimples, or cysts at the application site.
- •5. Active dermatosis (local or disseminated) that might interfere with
- •the results of the study.
- •6. Considered immune compromised.
- •7. History of diseases aggravated or triggered by ultraviolet radiation.
- •8. Participants with dermatographism.
- •9. Currently using any medication which in the opinion of the
- •investigator, may affect the evaluation of the study product, or place
- •the subject at undue risk.
- •10. Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal
- •anti-inflammatory drugs, and corticosteroids up to 2 weeks before
- •screening visit.
- •11. Oral or topical treatment with vitamin A acid and/or its derivatives
- •up to 1 month before the screening visit
- •12. Intention of being vaccinated during the study period or
- •vaccination within 3 weeks of the screening visit.
- •13. Currently receiving allergy injections, or due to receive an
- •injection within 7 days prior to Visit1, or expects to begin injections
- •during study participation
- •14. Previous history of atop, allergic reactions, irritation or intense
- •discomfort feelings to topical use products, cosmetics, or medication
- •15. Known or suspected intolerance or hypersensitivity to any of the
- •materials (or closely related compounds) or any of their stated
- •ingredient including any component of the patches
- •16. History of sensitization in a previous patch study
- •17. Participation in another clinical study (including cosmetic studies)
- •or receipt of an investigational drug within 30days of the screening
- •18. Recent history (within the last years) of alcohol or other
- •substance abuse
研究者
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