A study to assess the influence of 2 Bepanthen formulations on transepidermal water loss level and their tolerability on freshly tattooed skin under dermatological control in healthy subjects with intra-individual control
The cosmetic study will assess the performance and tolerability of 2 Bepanthen water-in-oil formulations on freshly tattooed skin in healthy adult volunteers.
- Signed informed consent obtained before any study-specific procedures; - Healthy adults, aged 18 to 60 years; - Skin type according to Fitzpatrick: II, III, IV; - Willingness to follow study-specific procedures and to show-up for the visits at the center at the scheduled date and time; - Willingness to adhere to the following tattoo related aspects: -- Getting 2 new comparable tattoos for intra-individual comparison; -- Tattooing completed in maximum 4 hours prior to baseline visit; -- Tattoos covered with plastic wrap after completion; -- Plastic wrap to be removed at the center during baseline visit for first dermatological tattoo examination; -- Standardized tattoo areas: upper, lower arm, chest, abdomen, leg, no dorsal body parts; -- Limitations of tattoo size: tattoo sizes will not be larger than what the tattoo artist is able to cover with max 2 h for each tattoo (therefore there is no lower and upper size limit by square centimeters). --Standardized tattoo color: black - Negative pregnancy test for women of childbearing potential
- History of atopic or allergic reaction to cosmetic products; - History of allergic reactions to tattoo inks*; - Other tattoo colors used than black; - Known allergies to any of the ingredients of the test products; - Any other skin disease on the whole body that would interfere with the clinical assessment in the opinion of the investigator; - Intake of drugs interfering with the immune system (e.g. corticosteroids, immunosuppressants and antihistamines) within 30 days prior to screening; - Any diseases that can cause immune suppression, such as diabetes, HIV, etc.; - Sunburn at the sites of planned tattoo; - Participation in any other clinical study or observational study within a period of 30 days prior to screening; - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational center)
Evic Product Testing Romania / S.C. Bio High Tech S.R.L.
Bucharest, Romania, 40256
E-mail: [email protected]
Phone: (+)1-888-84 22937
Cosmetic, single center study to assess the influence of 2 Bepanthen W/O formulations on TEWL and their tolerability on freshly tattooed skin under dermatological control in healthy subjects with intra-individual control