- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852563
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
Evaluation of the Safety and Efficacy of the Product Bepantol® Cream After the Dermatological Procedure in the Face.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo, Brazil, 06023-070
- Medcin Instituto Da Pele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women_Hemiface BAY207543
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.
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Product is applied to one hemiface.
Product is applied to one hemiface.
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Active Comparator: Women_Hemiface Vaseline
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.
|
Product is applied to one hemiface.
Product is applied to one hemiface.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin barrier integrity by TEWL probe
Time Frame: Up to 23 days
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The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
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Up to 23 days
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Dermic temperature by thermographic camera (FLIR)
Time Frame: Up to 23 days
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Up to 23 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin properties of the participants
Time Frame: Up to 23 days
|
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).
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Up to 23 days
|
Treatment satisfaction
Time Frame: Up to 23 days
|
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).
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Up to 23 days
|
Product evaluation
Time Frame: Up to 23 days
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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).
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Up to 23 days
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Number of adverse events by dermatological evaluation
Time Frame: Up to 23 days
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Up to 23 days
|
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Number of adverse events by ophthalmologic valuation
Time Frame: Up to 23 days
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Up to 23 days
|
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Severity of adverse events by dermatological evaluation
Time Frame: Up to 23 days
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Up to 23 days
|
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Severity of adverse events by ophthalmologic valuation
Time Frame: Up to 23 days
|
Up to 23 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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