Study Completed

Erythema, Skin recovery

Bayer Identifier:

20577

ClinicalTrials.gov Identifier:

NCT03852563

EudraCT Number:

Not Available

EU CT Number:

Not Available

A study to gain information how well dexpanthenol derma cream helps the face skin to recover after cosmetic lasering

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

30 - 60 Years

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

Trial summary

Enrollment Goal

Trial Dates

March 2019 - April 2019

Phase

N/A

Could I Receive a placebo

Products

Bepantol® Cream (BAY207543)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Medcin Instituto da Pele	Sao Paulo, 06023-070, Brazil

Primary Outcome

Skin barrier integrity by TEWL probe
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Time Frame:
Up to 23 days
Dermic temperature by thermographic camera (FLIR)
Time Frame:
Up to 23 days

Secondary Outcome

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).
Time Frame:
Up to 23 days
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).
Time Frame:
Up to 23 days
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).
Time Frame:
Up to 23 days
Number of adverse events by dermatological evaluation
Time Frame:
Up to 23 days
Number of adverse events by ophthalmologic valuation
Time Frame:
Up to 23 days
Severity of adverse events by dermatological evaluation
Time Frame:
Up to 23 days
Severity of adverse events by ophthalmologic valuation
Time Frame:
Up to 23 days

Trial design

Evaluation of the Safety and Efficacy of the product Bepantol® Cream after the dermatological procedure in the face.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms

Additional Information

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