Trial Condition(s):

Skin healing after tattooing

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

Bayer Identifier:

19931

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The cosmetic study will assess the performance and tolerability of 2 Bepanthen water-in-oil formulations on freshly tattooed skin in healthy adult volunteers.

Inclusion Criteria
- 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
Exclusion Criteria
- 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)

Trial Summary

Enrollment Goal
56
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Bepantol® Ointment (BAY207543)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Evic Product Testing Romania / S.C. Bio High Tech S.R.L.

Bucharest, Romania, 40256

Status
Completed
 

Trial Design