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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT03853538

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

27.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erythema Skin Recovery	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray) Other: Semisolid vaseline	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 28, 2019

Actual Primary Completion Date :

Mar 6, 2019

Actual Study Completion Date :

Mar 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Women_Hemiface BAY207543 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) Product is applied to one hemiface. Other: Semisolid vaseline Product is applied to one hemiface.
Active Comparator: Women_Hemiface 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.	Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray) Product is applied to one hemiface. Other: Semisolid vaseline Product is applied to one hemiface.

Arm

Intervention/Treatment

Experimental: Women_Hemiface BAY207543

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)

Product is applied to one hemiface.

Other: Semisolid vaseline

Product is applied to one hemiface.

Active Comparator: Women_Hemiface 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.

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)

Product is applied to one hemiface.

Other: Semisolid vaseline

Product is applied to one hemiface.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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