A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Title
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Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.

Conditions
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Skin Recovery

Intervention / Treatment
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* Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)
* Other: Semisolid vaseline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women_Inguinal side BAY207543<br>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. | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)<br>* Product is applied to one side of the inguinal region.<br>Other: Semisolid vaseline<br>* Product is applied to the other side of the inguinal region.<br>|
| Active Comparator: Women_Inguinal side Vaseline<br>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. | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)<br>* Product is applied to one side of the inguinal region.<br>Other: Semisolid vaseline<br>* Product is applied to the other side of the inguinal region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermal spray, Peeling, Skin hydration, Consumer satisfaction, Sensorial perception