A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After Laser Hair Removal in the Groin and Intimate Area

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 for hair removal (laser depilation) in the groin and intimate area in adult women. After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also 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 lasering depilation in the 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 and Efficacy Evaluation of the Use of Bepantol® Derma Spray After Laser Depilation in the Inguinal Region in Adult Women - 21 Days Use at Home

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 a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region 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 Hyperpigmentations 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 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with BAY207543 is 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 one side of the inguinal region.<br>|
| Active Comparator: Women_Inguinal side Vaseline<br>Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with vaseline is 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 one 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 9 to 45 (a higher score represents higher efficacy). | Up to 23 days | 
| Treatment satisfaction | Participants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (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 | 
| Severity of adverse events by dermatological 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, Laser depilation, Skin hydration, Consumer satisfaction, Sensorial perception