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

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