CTRI/2022/03/041220已完成未知
Evaluation of dermatological safety by 24 hrs patch test under complete occlusion on healthy human subjects
Glance Collective Private Limited0 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.Subjects with Fitzpatrick skin type III (medium brown European) to V (middle-east type, Indian,Amerindian) (Refer Annexure â??IV).
- •2.Healthy adult human volunteers aged 18 â?? 55 years (both ages inclusive). Subjects willing to submit proof of identity [a copy of the valid photo identity (ID) cards provided by the government body or employers] and date of birth (DOB) for age confirmation/eligibility to participate in the trial.
- •3.Healthy adult male and female subjects.
- •4.Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study
- •5.Subjects with normal outcome of the medical history within last 04 weeks prior to start of the study.
- •6.Non pregnant women and non lactating mothers.
- •7.Urine pregnancy test to the performed for confirmation in females.
- •8.Subjects able to communicate effectively.
- •9.Willingness to avoid intense UV exposure on test site ( sun or artificial UV), during the course of the study.
- •10.Willingness to avoid water contact (i.e. swimming)or activity which cause sweating (i.e. exercise, sauna,etc.) during the course of the study.
- •11.Ready to wear loose cotton clothes.
- •12.Subjects who ate capable of understanding and having signed the informed consent form after detailed description of the treatment procedures, benefits and potential risks, if any.
- •13.In the judgment of the principal investigator (PI), able to comply with protocol requirements.
排除标准
- •1.Subjects having known hypersensitivity to the study product or its constituents
- •2.Subjects having clinically significant active dermatitis or skin disease(s) anywhere in the body.
- •3.People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out activities like excessive/brisk walking and exercising, etc.)
- •4.Current use of immunosuppressive drugs and/or organ transplant.
- •5.Current use of any topical or systemic drug that could interfere with the study treatments/assessments,(corticosteroids,anti-inflammatory drugs, antihistamines, retinoids) within the last 4 weeks prior to participation in the study.
- •6.Any significant medical condition which, in the investigatorsâ??sjudgements, could interfere with subjetsâ??s participation in the study (asthma, insulin-dependent diabetes, malignancy, autoimmune diseases,etc.)
- •7.Any concomitant medications that in the investigatorâ??s judgment can confound or alter test results or evaluation of adverse events.
- •8. Pregnant and lactating females
- •9.Vaccination during three weeks preceding the study or intended during the course of the study.
- •10.Subjects who would not fit into inclusion criteria.
- •11.Subjects with past history of contact dermatitis.
- •12.Subjects who would not give consent for study participation
- •13.Subjects not willing to submit proof of identity and Date of birth in the form of a copy of valid photo ID proof/card(s)
- •Specific criteria:
- •1.Having eczema, psoriasis, lichen plan, vitiligowhatever the considered area be.
- •2.Having disorder of the healing (whatever the considered area)
- •3.Having rhinitis, allergic conjunctivitis or rhino sinusitis.
- •4.Having allergy to perfumes and/or preservatives in cosmetic products.
- •5.Having allergy to plaster/cotton bandage.
- •6.Having food allergy.
- •7.Having cardiovascular pathology (taking beta blockers).
- •8.Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc.
- •9.Taking a retinoid based treatment by general or oral route.
- •10.Taking specific treatment- Inter scapular (between the shoulder blades) or on the inner left or right arm.
- •11.Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study.
- •12.Having miliaria (prickly heat) on the site of application.
- •13.Presenting too many naevus on the site of application.
- •14.Having high pilosity on the site of application.
- •15.Refusing to follow the restrictions below during the study:
- •Instructions to the subjects (to be followed strictly)
- •1.During the first 24 hours (after patch application), neither cosmetic products nor water must be applied anywhere near nor on the site of LP application.
- •2.Till the follow up period of until T8 days, only water is accepted for cleaning from the first reading i.e. T2 days (24 hours after the patch removal).
- •3.Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches).
- •Do not expose the application site to the sun.
研究者
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