Evaluation of Dermatological Safety of Test Products, Positive and Negative Controls by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) studies at by NovoBliss Research by 24 Hours Patch Test Under Complete Occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination).
研究概览
简要总结
Standardization is the process of implementing and developing technical standards based on the consensus of different users, evaluators, performers. Standardization can help to maximize compatibility, interoperability/interevaluator, safety, repeatability, and quality.
It can also facilitate the commoditization of formerly custom processes. The process of standardization can itself be standardized. This validation study report describes the standardization process for Patch Testing Studies. By the implementation of this standardization and validation, we have maximized our quality of performing patch testing studies for all types of dermal products inclusive of Cosmetics, Personal Care Products, Pharmaceuticals Drugs, topical products, baby care products, mother care products, etc.
The objective of this validation study was to standardize the methods, procedural steps and validate the positive and negative controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) by 24 Hours Patch Test Under Complete Occlusion or any patch testing studies {i.e., Cumulative Irritation Patch Testing (CIPT), Human Repeat Insult Patch Testing (HRIPT), Phototoxicity and Photo allergy Studies} conducted at/by NovoBliss Research as per study design on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination). This standardization and validation study was also for establishing documentary evidence demonstrating that procedural steps, processes, and clinical activities carried out in patch testing for Dermal Safety Studies to maintains the desired level of compliance and consistency.
Overall Conclusion:
No complaints of adverse effects or worsening of skin conditions were reported on a single application of the product during and till the completion of the study.
At the end of the study, we can conclude that both the concentration of the positive control i.e. 1% w/v and 3% w/v SLS solution showed a high irritancy level at Visit 3 (Day 3) as compared to another test article, negative control. As per PCD 19: Cosmetics [third revision and IS 4011:2018 Methods of Test for Safety Evaluation of Cosmetics] and CHD 25: Soaps and Other Surface-Active Agents Sectional Committee [first revision and IS 13424:2001 Safety evaluation of bathing bars and toilet soaps] the results of negative and positive controls were meet the criteria. From this standardization and validation study. We conclude to have set a benchmark for patch testing studies that produce consistent, compatible, accurate, qualitative, and reproducible results, controlled testing methods of patch testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Outcome Assessor 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
- •Age: 18-65 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Subject with normal Fitzpatrick skin type III to V (human skin colour determination scale).
- •Females of childbearing potential must have a self-reported negative urine pregnancy test before patch application.
- •Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •The subject is in good general health as determined by the Investigator on the basis of medical history.
- •Subjects is willing to maintain the test patches in designated positions for 24 Hours.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
- •10.The subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given.
排除标准
- •A subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- •Medication that may affect skin response and/or past medical history.
- •A subject having a history of diabetes
- •The subject has a history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •A subject suffering from any active clinically significant skin diseases which may contraindicate.
- •A subject has a history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •Participation in any patch test for irritation or sensitization within the last four weeks.
- •A subject has a history of asthma or COPD (Chronic obstructive pulmonary disease).
- •Use of any: i.
- •Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •Systemic or topical corticosteroids at patch site within four weeks of test product application (steroidal nose drops and/or eye drops are permitted)
- •Topical drugs used at the application site.
- •Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematosus.
- •An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
- •Subject with known allergy or sensitization to medical adhesives, bandages.
- •Participation in other patch studies simultaneously.
结局指标
主要结局
The objective of this validation study is to evaluate the standardize the methods, procedural steps, validate the controls and evaluations techniques that are used during the conduct of Primary Irritation Patch Test (PIPT) studies at by NovoBliss Research by 24 Hours Patch Test Under Complete Occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal and Combination).
时间窗: At 30 mins, 24 hours and 168 hours post-patch removal
次要结局
- Safety of the Subjects(Irritation Scoring at 30 mins, 24 hours and 168 hours post-patch removal)