check_circleStudy Completed

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

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.

Key Participants Requirements

Sex

All

Age

18 - 60 Years
  • - 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)

Trial summary

Enrollment Goal
56
Trial Dates
January 2018 - May 2018
Phase
N/A
Could I Receive a placebo
No
Products
Bepantol® Ointment (BAY207543)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Evic Product Testing Romania / S.C. Bio High Tech S.R.L.Bucharest, 40256, Romania

Primary Outcome

  • Skin healing after tattooing
    Visually, by the same investigator or technician, supervised by the investigator, under standardized light
    date_rangeTime Frame:
    Up to 14 days
  • Transepidermal water loss level (TEWL)
    Performed by the TewameterTM 300 (Courage + Khazaka)
    date_rangeTime Frame:
    Up to 14 days
  • Dermal tolerability
    Using subject daily log.
    date_rangeTime Frame:
    Up to 14 days
  • Product performance and tolerability by use of a subject questionnaire
    date_rangeTime Frame:
    Up to 14 days

Trial design

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
Trial Type
Interventional
Intervention Type
Other
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2