Evaluation of the safety of test products for primary skin irritation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.
研究概览
简要总结
· It is a test under dermatological control, monocentric,randomized, double blinded, controlled and comparative versus negative control.
· Therewill be 4 Products involved in the study- 2 test products, 1 negative control(0.09% isotonic saline solution) and 3% Sodium Lauryl sulphate solutionwherever applicable.
Procedureto be followed for occluded patch test.
· Procedurefor making 3% w/w solution of SLS: Weigh 0.3 g of sodium Laurylsulphate in a tarred beaker. Add sufficient quantity of water to make up theweight to 10 g.
· At V1 (0hrs) **:**0.04 ml or g (as applicable)of the test products, negative control (0.9% isotonic saline solution) and 3%solution of sodium lauryl sulphate willbe filled in different wells of Patch chambers and will be applied occlusively on upper armsof each volunteer by C.L.A.I.M.S. personnelat Hour 0. Duration of occlusion will be 24 hours.
· The Test Products will be filled in Patchchambers as per a randomization code generated by QA Department. NegativeControl and 3% Sodium Lauryl sulphate will not be randomized.
· At V2:(24 hrs): Patch will be removed and clinical examination of skin will becarried out by Investigator.
· At V3:(48hrs.): Clinical examination and scoring of test area (skin on upper arm)will be performed.
Procedureto be followed for ROAT.
· At V1,2x 2 square cm test sites will be marked on the antecubital fossa of armwithout randomization.
· Approximately 0.16 g of sample will be appliedon the marked test site. The Products will be rubbed in for 30 seconds gentlywith finger stall and kept on for 30 minutes
· After 30 minutes the volunteer will be allowedto go.
· The same procedure is repeated everyday till 5applications are completed.
· At V5, thevolunteer will wait for I hour after application of Products, the site will be washedand graded thereafter.
· Occluded Patch and ROAT reactions would begraded using Draize scale.
If a reaction is observed, the subject willbe requested to return to research centre till reactions are resolved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men and/or women.
- •2.SLS responders from database or determined by applying SLS patch on volunteers.
- •3.Between 18 and 65 years.
- •4.Photo type III and IV.
- •5.Having apparently healthy skin on test area.
- •6.Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study.
- •7.For whom the investigator considers that the compliance will be correct.
- •8.Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •9.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- •10.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
- •11.Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna…), during the course of the study.
- •12.Ready to wear loose cotton clothes.
排除标准
- •1.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, exercising etc).
- •2.Pregnant women and lactating women.
- •(as confirmed by UPT) 3.Scars, excessive terminal hair or tattoo on the studied area.
- •4.Dermatological infection/pathology on the level of studied area.
- •5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material).
- •6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •8.Subject in an exclusion period or already participating in another similar cosmetic or therapeutic trial as identified during screening on visit 1 (V1).
结局指标
主要结局
To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.
时间窗: To evaluate the cutaneous tolerance by dermatological scoring of skin reactions using Draize scale.
次要结局
未报告次要终点