CTRI/2024/12/078726已完成不适用
A Randomised, Evaluator-Blinded, Comedogenicity Study to Evaluate the Comedogenic Potential of Test Products in Healthy, Adult, Male and Female Subjects using Cyanoacrylate Follicular Biopsy Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To determine comedogenicity of the test product - if score is 1-3 in one or more subjects.
研究概览
简要总结
A randomized, evaluator-blinded, comedogenicity study to evaluate the comedogenic potential of the test products in human healthy, adult, male and female subjects by patch test.
The potential subjects with prominent follicular orifices with ability to form comedones will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
The subject will be instructed to visit the facility as per the below visits:
• Visit 01 (Within 15 days): Screening
• Visit 02 (Day 01): Enrolment, Randomization, 1st Application
• Visit 03 to Visit 13 (Day 03 ±1 Day to Day 26 ±1 Day): Patch application, patch removal, and irritation scoring
• Visit 14 (Day 29 ± 1 Day): End of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-50 years (both inclusive) at the time of consent 2) Sex: Healthy male or healthy non-pregnant and non-lactating females.
- •Female of childbearing potential must have a negative urine pregnancy test performed on screening visit.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Subject with presence of prominent follicular orifices and the ability to form comedones on the upper part of the back (shoulder area).
- •Subjects willing to maintain the test patches on designated application sites for consecutive 29 days (4 weeks).
- •The Subjects willing to give written informed consent and willing to follow study procedure.
- •Subject are willing and able to make all evaluation visits and follow the protocol instructions.
排除标准
- •Subjects who do not have presence of prominent follicular orifices and not have ability to form comedones on the upper part of back.
- •Subject has damaged skin in or around application sites, tattoos, scars, excessive hair, moles, burn marks/ scars or other disfiguration of the application sites.
- •Medical past and present history of significant dermatologic diseases or conditions, such as atopy, psoriasis, eczema, atopic dermatitis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
- •History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the patch application site.
- •Presence of open sores or other skin abnormalities at the application site.
- •History of skin allergy to adhesive tapes, adhesive materials or with other medications, cosmetics, toiletries, fragrances, topical skin products or other dermatological products.
- •Subject have used an active topical or systemic acne medication in the previous two weeks.
- •Have significant diseases or clinically significant abnormal findings during screening (brief medical history, abbreviated physical examination, and laboratory evaluations).
- •Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •History of presence of bronchial asthma.
- •Uses of any topical products (except soap) at application site prior to 24 hours of patch application.
- •Routine high dosage use of anti-inflammatory drugs (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamines medications, antibiotics, retinoids, or exfoliative agents (steroid nose drops and/or eye drops are permitted) within 72 hrs prior to patch application.
- •Subject has a 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.
- •Show evidence of dermatological diseases or have a history of sun hypersensitivity and photosensitive dermatoses.
- •Have active acne vulgaris over the upper back.
- •Subject with positive hepatitis-self reported (subtypes B).
- •Subject with known history of positive HIV.
- •Pregnant or lactating females.
- •Be an employee of the sponsor or the site conducting the study.
结局指标
主要结局
To determine comedogenicity of the test product - if score is 1-3 in one or more subjects.
时间窗: Baseline before application of the test product to Day 01 to visit 14 (Day 29).
次要结局
- To determine the degree of microcomedone of test products.(Baseline before application of the test product to)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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