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

Phase 4

Completed

Interventions: Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)
Other: Semisolid vaseline

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Women_Hemiface Vaseline	Semisolid vaseline	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.
Women_Hemiface BAY207543	BAY207543 (Bepanthol, Bepantol® Derma Spray)	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 BAY207543	Semisolid vaseline	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	BAY207543 (Bepanthol, Bepantol® Derma Spray)	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.

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss by TEWL probe	Up to 23 days	The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Dermic temperature by thermographic camera (FLIR T530sc)	Up to 23 days

Secondary Outcome Measures

Name	Time	Method
Skin properties of the participants	Up to 23 days	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).
Treatment satisfaction	Up to 23 days	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).
Product evaluation	Up to 23 days	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).
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