Completed
Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
What is being tested
BAY207543 (Bepanthol, Bepantol® Derma Spray)
+ Semisolid vaseline
DrugOther
Who is being recruted
Behavior
+ Consumer Behavior
From 18 to 60 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: February 2019
Summary
Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 12, 2019
Actual date on which the first participant was enrolled.The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region. Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.
Official TitleSafety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
33 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorConsumer Behavior
Criteria
2 inclusion criteria required to participate
Phototypes I and II according to the Fitzpatrick scale;
Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.
3 exclusion criteria prevent from participating
Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAdult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated.
Group II
Active ComparatorAdult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center