An Open Label, Interventional, Prospective Clinical Study to Assess the Safety and Efficacy of Eltior Skin Barrier Moisturizer to Evaluate Hydration and Skin Barrier Function for varied skin types in Healthy Human Participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is an open-label, single-centre, single-arm, prospective interventional clinical study designed to evaluate the safety and efficacy of Eltior Skin Barrier Moisturizer in improving skin hydration and enhancing skin barrier function in healthy participants across all skin types.
Up to 30 participants including both males and non-pregnant, non-lactating females, aged 18 to 55 years (inclusive) will be enrolled in the study to complete 25 participants for the study. Participants will be enrolled in an equal ratio across oily, dry, normal, sensitive, and combination skin types
The potential participants will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the participants. Participants will be contacted telephonically by recruiting department prior the enrolment visit.
The participants will be instructed to visit the facility as per the below visits.
ü Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations, Product Usage, Post Usage Evaluations
ü Visit 02 (Day 02): Evaluations
ü Visit 03 (Day 15 **±**2 Days): Final Evaluations, End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 18 to 55 years at the time of consent.
- •2.Sex: Healthy males and non-pregnant, non-lactating female participants having oily, dry, normal, sensitive or combination skin type.
- •3.Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •4.Participants forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites.
- •5.If the participant is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •6.Participants who commit not to use medicated skincare products other than the test product for the entire duration of the study.
- •7.Participants are not allowed to participate in any other study until this study is complete.
- •8.Patients are willing to give written informed consent and are willing to come for regular follow up.
- •9.Participants must agree to record each use of the test products in the participant’s diary card on daily basis.
- •10.Participant who have not participated in a similar study in the past three months.
排除标准
- •1.Participants with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •2.Participants that are pregnant and/or breastfeeding.
- •3.The participant has a known allergy or sensitivity to any cosmetic product.
- •4.The participant has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the participant.
- •5.The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
- •6.History of chronic illness which may influence the cutaneous state.
研究者
Dr Nayan Patel MBBS
NovoBliss Research Private Limited