None listed
Conditions
Interventions
Intervention1: Aquasoft baby Cream (G1910): Product A: Application is carried out once at site on the marked areas of 2.5 x 2.5 cm2 on the randomized inner forearms for the period of 24 hours
Interv
Sponsors
Ajanta Pharma 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 65 years of age. 4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.). 5. Having dry skin on forearms.
Exclusion criteria
Exclusion criteria: 1. For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2. Having refused to give his/her assent by not signing the consent form and Informed consent form 3. Taking part in another study liable to interfere with this study 4. Being known diabetic case 5. Known asthma case 6. Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7. Being known thyroid case 8. Being epileptic. 9. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol) 10. Known case of hypersensitivity. 11. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13. Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. 14. Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study. 15. Refusing to follow the restrictions below during the study: - For Females: 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, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol). - Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. - During the study: Do not use other cosmetic products than the tested product to the studied areas. 16. Having started, changed, or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroidâ?¦) in the past 3 months. 17. Having taken an oral retinoid-based treatment in the past 6 months 18. Having taken a local retinoid-based treatment on the studied areas in the previous month 19. Having had beauty treatment (e.g. scrub, manicure, self-tanning product â?¦) in the previous week 20. Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week. 21. Having consumed caffeine-based products (coffee, cola, tea, â?¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 22. Having practiced intensive sports during the day prior to the T0 measurements 23. Having wounds, scars, sunburns, tattoos and piercing on test site. 24. Having hair on test site. 25. Having applied another product than water on the studied areas in the morning of the T0 measurements 26. Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements. 27. Having used moisturizing products on the arms during 24 hours prior to T0 measurements. 28. Refusing to follow the restrictions below during the study: <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement in capacitance value i.e skin moisturizationTimepoint: Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| prevention of the water loss from skinTimepoint: Baseline, 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours & 24 hours | — |
Countries
India
Contacts
Public ContactDr Mohit Lalvani
MASCOT-SPINCONTROL India Pvt. Ltd.
Outcome results
None listed