check_circleStudy 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
  • - 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

  • - 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
33
Trial Dates
March 2019 - April 2019
Phase
N/A
Could I Receive a placebo
No
Products
Bepantol® Cream (BAY207543)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Medcin Instituto da PeleSao 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.
    date_rangeTime Frame:
    Up to 23 days
  • Dermic temperature by thermographic camera (FLIR)
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime Frame:
    Up to 23 days
  • Number of adverse events by dermatological evaluation
    date_rangeTime Frame:
    Up to 23 days
  • Number of adverse events by ophthalmologic valuation
    date_rangeTime Frame:
    Up to 23 days
  • Severity of adverse events by dermatological evaluation
    date_rangeTime Frame:
    Up to 23 days
  • Severity of adverse events by ophthalmologic valuation
    date_rangeTime 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
2

Additional Information

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