A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering

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 and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation. After the dermatological procedure, 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 and reduction of erythema after non-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.

Official Title
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Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.

Conditions
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Erythema, 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 or II according to the Fitzpatrick scale Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma 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 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

Ages Eligible for Study
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Minimum Age: 30 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_Hemiface BAY207543<br>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. | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)<br>* Product is applied to one hemiface.<br>Other: Semisolid vaseline<br>* Product is applied to one hemiface.<br>|
| Active Comparator: Women_Hemiface Vaseline<br>Adult women receive the test product randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated. | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)<br>* Product is applied to one hemiface.<br>Other: Semisolid vaseline<br>* Product is applied to one hemiface.<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 | 
| Dermic temperature by thermographic camera (FLIR T530sc) |  | 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 | 
| 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 | 

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