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

Erythema Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of the Product Bepantol® Cream After the Dermatological Procedure in the Face.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852563
• Other study ID #: 20577
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: April 22, 2019

Study information

• Verified date: April 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Erythema
• Skin Recovery

Intervention

Drug:
• BAY207543 (Bepanthol)
Product is applied to one hemiface.

Other:
• Semisolid vaseline
Product is applied to one hemiface.

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier integrity by TEWL probe	The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.	Up to 23 days
Primary	Dermic temperature by thermographic camera (FLIR)		Up to 23 days
Secondary	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 8 to 55 (a higher score represents higher efficacy).	Up to 23 days
Secondary	Treatment satisfaction	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).	Up to 23 days
Secondary	Product evaluation	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).	Up to 23 days
Secondary	Number of adverse events by dermatological evaluation		Up to 23 days
Secondary	Number of adverse events by ophthalmologic valuation		Up to 23 days
Secondary	Severity of adverse events by dermatological evaluation		Up to 23 days
Secondary	Severity of adverse events by ophthalmologic valuation		Up to 23 days

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