Safety & efficacy assessment of products on skin.
- Registration Number
- CTRI/2022/05/042725
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Indian female subjects
2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
3.Between 18 and 40 years of age.
4.Skin is healthy on the studied anatomic unit (e.g., free of eczema, wounds, inflammatory scar).
5.Having dry skin on inner forearms with corneometry reading of <30.
1.For Female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2.Having started, changed or stopped a hormonal treatment (e.g., hormonal contraception, Hormonal Replacement Therapy, thyroid) in the past 3 months
3.Having taken an oral retinoid-based treatment in the past 6 months.
4.Having had a local retinoid-based treatment on the studied areas in the previous month.
5.Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) in the previous week
6.Having applied a moisturizing product on the studied areas in the 5 days preceding the start of the study. (only hands cleaned with water is accepted)
7.Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week
8.Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements
9.Having practiced intensive sports during the day prior to the T0 measurements
10.Having wounds, Scars, sunburns, tattoos and piercing on test site.
11.Having applied another product than water on the studied areas in the morning of the T0 measurements
12.Having had an intensive UV exposition on the forearms (solariums, sun) during 5 days prior to T0 measurements.
13.Having used any skin care products as well as skin care cleansers such as bath/shower oils on the forearms during 5 days prior to T0 measurements.
14.Having hair on test site.
15.Refusing to follow the restrictions below during the study:
Do not take part in any family planning activities leading to pregnancy and breastfeeding , Do not take part in another study liable to interfere with this study , Do not take 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), During the study: Do not use other cosmetic products than the tested product to the studied areas., Do not have beauty treatment (e.g. scrub, manicure self-tanning product) , Do not practice water activities (swimming pool, sauna, hammam, balneotherapy etc.), Do not drink/ eat caffeine-based products (coffee, cola, tea), alcohol, highly spiced food, nor smoke , Do not practice sport , Do not apply any product on inner forearms including water., Do not wipe their inner forearms., Do not wear jewels on the wrists, Do not have an intensive UV exposition on the inner forearms (solariums, sun).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent improvement in capacitance value i.e skin moisturizationTimepoint: 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application
- Secondary Outcome Measures
Name Time Method Percent reduction in transepidermal water loss (TEWL), Percent improvement in skin softness , safety of ProductTimepoint: 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours & 24 hours after product application