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In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women_Inguinal side BAY207543 | Experimental | Adult 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. |
|
| Women_Inguinal side Vaseline | Active Comparator | Adult 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY207543 (Bepanthol, Bepantol® Derma Spray) | Drug | Product is applied to one side of the inguinal region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss by TEWL probe | The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300. | 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 12 to 60 (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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| Semisolid vaseline | Other | Product is applied to the other side of the inguinal region. |
|
Participants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (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 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (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 gynecological evaluation | Up to 23 days |
| Severity of adverse events by dermatological evaluation | Up to 23 days |
| Severity of adverse events by gynecological evaluation | Up to 23 days |
| ID | Term |
|---|---|
| D003258 | Consumer Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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