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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women_Hemiface BAY207543 | Experimental | 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. |
|
| Women_Hemiface Vaseline | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY207543 (Bepanthol) | Drug | Product is applied to one hemiface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin barrier integrity by TEWL probe | The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300. | Up to 23 days |
| Dermic temperature by thermographic camera (FLIR) | Up to 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 23 days |
| Treatment satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medcin Instituto da Pele | São Paulo | 06023-070 | Brazil |
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.
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| ID | Term |
|---|---|
| D004890 | Erythema |
| D003258 | Consumer Behavior |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Semisolid vaseline | Other | Product is applied to one hemiface. |
|
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). |
| Up to 23 days |
| 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). | Up to 23 days |
| Number of adverse events by dermatological evaluation | Up to 23 days |
| Number of adverse events by ophthalmologic valuation | Up to 23 days |
| Severity of adverse events by dermatological evaluation | Up to 23 days |
| Severity of adverse events by ophthalmologic valuation | Up to 23 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |