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

Not Applicable

Completed

• Conditions: Erythema; Skin Recovery
• Interventions: Drug: BAY207543 (Bepanthol); Other: Semisolid vaseline

• Registration Number: NCT03852563
• Lead Sponsor: Bayer

Brief Summary

In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.

After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.

Detailed Description

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-03-18
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Phototypes I or II according to the Fitzpatrick scale
• Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
• Normal eye examination

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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 and cutaneous marks 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
• People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
• People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women_Hemiface Vaseline	Semisolid vaseline	Adult women receive BAY207543 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)	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)	Adult women receive BAY207543 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
Skin barrier integrity 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)	Up to 23 days

Secondary Outcome Measures

Name	Time	Method
Product evaluation	Up to 23 days	Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (a higher score represents higher product satisfaction).
Severity of adverse events by ophthalmologic valuation	Up to 23 days
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 8 to 55 (a higher score represents higher efficacy).
Number of adverse events by ophthalmologic valuation	Up to 23 days
Severity of adverse events by dermatological evaluation	Up to 23 days
Treatment satisfaction	Up to 23 days	Participants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (a higher score represents better treatment satisfaction).
Number of adverse events by dermatological evaluation	Up to 23 days

Trial Locations

Locations (1)

Medcin Instituto da Pele; 🇧🇷 Sao Paulo, Brazil