None listed
Conditions
Interventions
Intervention1: Cebhydra Intense: 2microlitre per cm² of the test product will be applied to randomized 3×3 cm² sites on the forearm. The product will be gently spread using a finger cot and left uncov
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Indian male and 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 less than 30.
Exclusion criteria
Exclusion criteria: 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). 16) Between T0 and T+24 hours after Product application measurements:Do not use skin care products on the inner forearms, Do not wash the inner forearms, Do not use surfactant containing product on the test site on inner forearms, Daily morning hygiene with water accepted except on inner forearms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement in capacitance value assessed through corneometryTimepoint: Baseline, 24 Hours after product application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent improvement in capacitance through corneometry, Percent reduction in transepidermal water loss (TEWL)through tewametry, Percent improvement in skin softness through dermatologist evaluation , Percent panel agreement for moisturization effect based on subject self-evaluation questionnaire, • Subject self-evaluation questionnaire score for cosmetic appeal and safety, • Adverse events (AEs) and serious adverse events (SAEs) reported by the subject and the dermatologistTimepoint: Baseline, 30 minutes, 4 hours, 8 hours, 24 Hours after product application. | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed