Back to resultsA Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
Primary Purpose
Erythema, Skin Recovery
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
BAY207543 (Bepanthol)
Semisolid vaseline
Sponsored by
About this trial
This is an interventional treatment trial for Erythema focused on measuring Skin cream, Ablative lasering, Skin hydration, Consumer satisfaction, Sensorial perception
Eligibility Criteria
Inclusion Criteria:
- Phototypes I or II according to the Fitzpatrick scale
- Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
- Normal eye examination
Exclusion Criteria:
- Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
- Hyperpigmentation and cutaneous marks in the test area that intervenes with the evaluation of possible reactions
- Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
- Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
- People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
- People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity
Sites / Locations
- Medcin Instituto da Pele
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Women_Hemiface BAY207543
Women_Hemiface Vaseline
Arm Description
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.
Outcomes
Primary Outcome Measures
Skin barrier integrity by TEWL probe
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Dermic temperature by thermographic camera (FLIR)
Secondary Outcome Measures
Skin properties of the participants
Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 8 to 55 (a higher score represents higher efficacy).
Treatment satisfaction
Participants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (a higher score represents better treatment satisfaction).
Product evaluation
Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (a higher score represents higher product satisfaction).
Number of adverse events by dermatological evaluation
Number of adverse events by ophthalmologic valuation
Severity of adverse events by dermatological evaluation
Severity of adverse events by ophthalmologic valuation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852563
Brief Title
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
Official Title
Evaluation of the Safety and Efficacy of the Product Bepantol® Cream After the Dermatological Procedure in the Face.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
April 22, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.
After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.
Detailed Description
The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after ablative lasering on the face.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Skin Recovery
Keywords
Skin cream, Ablative lasering, Skin hydration, Consumer satisfaction, Sensorial perception
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women_Hemiface BAY207543
Arm Type
Experimental
Arm Description
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.
Arm Title
Women_Hemiface Vaseline
Arm Type
Active Comparator
Arm Description
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.
Intervention Type
Drug
Intervention Name(s)
BAY207543 (Bepanthol)
Intervention Description
Product is applied to one hemiface.
Intervention Type
Other
Intervention Name(s)
Semisolid vaseline
Intervention Description
Product is applied to one hemiface.
Primary Outcome Measure Information:
Title
Skin barrier integrity by TEWL probe
Description
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Time Frame
Up to 23 days
Title
Dermic temperature by thermographic camera (FLIR)
Time Frame
Up to 23 days
Secondary Outcome Measure Information:
Title
Skin properties of the participants
Description
Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 8 to 55 (a higher score represents higher efficacy).
Time Frame
Up to 23 days
Title
Treatment satisfaction
Description
Participants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (a higher score represents better treatment satisfaction).
Time Frame
Up to 23 days
Title
Product evaluation
Description
Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (a higher score represents higher product satisfaction).
Time Frame
Up to 23 days
Title
Number of adverse events by dermatological evaluation
Time Frame
Up to 23 days
Title
Number of adverse events by ophthalmologic valuation
Time Frame
Up to 23 days
Title
Severity of adverse events by dermatological evaluation
Time Frame
Up to 23 days
Title
Severity of adverse events by ophthalmologic valuation
Time Frame
Up to 23 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Phototypes I or II according to the Fitzpatrick scale
Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
Normal eye examination
Exclusion Criteria:
Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
Hyperpigmentation and cutaneous marks in the test area that intervenes with the evaluation of possible reactions
Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity
Facility Information:
Facility Name
Medcin Instituto da Pele
City
Sao Paulo
ZIP/Postal Code
06023-070
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
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