NCT03852563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

March 18, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

February 15, 2019

Last Update Submit

April 16, 2020

Conditions

ErythemaSkin Recovery

Keywords

Skin creamAblative laseringSkin hydrationConsumer satisfactionSensorial perception

Outcome Measures

Primary Outcomes (2)

  • 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

  • Dermic temperature by thermographic camera (FLIR)

    Up to 23 days

Secondary Outcomes (7)

  • Skin properties of the participants

    Up to 23 days

  • Treatment satisfaction

    Up to 23 days

  • Product evaluation

    Up to 23 days

  • Number of adverse events by dermatological evaluation

    Up to 23 days

  • Number of adverse events by ophthalmologic valuation

    Up to 23 days

  • +2 more secondary outcomes

Study Arms (2)

Women_Hemiface BAY207543

EXPERIMENTAL

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)Other: Semisolid vaseline

Women_Hemiface Vaseline

ACTIVE COMPARATOR

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.

Drug: BAY207543 (Bepanthol)Other: Semisolid vaseline

Interventions

BAY207543 (Bepanthol)DRUG

Product is applied to one hemiface.

Women_Hemiface BAY207543Women_Hemiface Vaseline
Semisolid vaselineOTHER

Product is applied to one hemiface.

Women_Hemiface BAY207543Women_Hemiface Vaseline

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medcin Instituto da Pele

São Paulo, 06023-070, Brazil

Location

Related Links

MeSH Terms

Conditions

ErythemaConsumer Behavior

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 25, 2019

Study Start

March 18, 2019

Primary Completion

April 22, 2019

Study Completion

April 22, 2019

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

BR(1)