CTRI/2024/10/074728已完成不适用
Evaluation of safety and efficacy of Roll on in reducing sweat, sweat malodor, axillary pigmentation and enhancing skin moisturization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ITC LIMITED
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Controlling Sweat and Sweat malodor
研究概览
简要总结
Study Population: About 72 healthy human adult volunteers of either gender in the age grp of 19y to 45y, will be enrolled for studying the sweat and sweat odor controlling efficacy of test products.
Study duration: 13 days, 7 days of conditioning phase and 3 days of product intervention phase and 3 additional days of observation.
Assessments:
Instrumental measurement of sweat, skin hydration, Color.
Sensory assessment of skin condition, sweat and related odor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects 2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 3)Having mild to moderate malodour.
- •Having sweat and visible underarm pigmentation 5)Having shaved under arms two days before each study visit.
- •Having mild to moderate axillary odour and whose left vs right axillary odour levels are more or less the same.
- •Subjects representing varied skin 8)Exhibiting good tolerance to the investigational product with no signs of sensitivity.
排除标准
- •For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give assent by not signing the consent form 3) Taking part in another study liable to interfere with this study 4) Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5) Having a progressive asthma.
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8) Having cutaneous hypersensitivity 9) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin￾ based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) and/or smoked in the two hours preceding the measurements 12) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14) Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Controlling Sweat and Sweat malodor
时间窗: Baseline, Immediate after application, 8Hours, 24 hours, Day 3, Day 6
次要结局
- Reducing Axillary hyperpigmentation and enhancing skin(Moisturization)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A study on efficacy of oral Ayurvedic formulation (Bhringarajadi Rasayana) in Gray Hairs at age group of 20 to 30 years individuals.CTRI/2025/01/079719Dr Yogesh Kashinath Shewale100
已完成
不适用
to check the effect of anti aging serum in both healthy Indian males and females in reducing wrinkles fine lines pigmentationCTRI/2025/01/079227Cipla Ltd35
尚未招募
不适用
An Open Label Single Dose Two Treatment Two Period Two Way Crossover Oral Pharmacokinetic Study Healthy Adult Human Male And Female Subjects Under Fed ConditionsCTRI/2025/01/079823Bioactives LLC8
尚未招募
不适用
An Open Label Study Single Dose Crossover Oral Bioequivalence Study Comparing Dexamfetamine Sulfate 5 mg TabletsCTRI/2024/11/077313Nova Pharmaceuticals Australasia Pty Ltd24
尚未招募
不适用
A study to compare the effectiveness and safety of Desidustat tablets with another treatment (ESA) for anemia in patients with chronic kidney disease who are on peritoneal dialysis.CTRI/2024/12/07785090