NCT03853538

Brief Summary

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation. After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2019

Completed
18 days until next milestone

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
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

February 15, 2019

Last Update Submit

March 5, 2020

Conditions

ErythemaSkin Recovery

Keywords

Dermal sprayAblative laseringSkin hydrationConsumer satisfactionSensorial perception

Outcome Measures

Primary Outcomes (2)

  • Transepidermal water loss 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 T530sc)

    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, Bepantol® Derma Spray)Other: Semisolid vaseline

Women_Hemiface Vaseline

ACTIVE COMPARATOR

Adult women receive the test product randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.

Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray)Other: Semisolid vaseline

Interventions

BAY207543 (Bepanthol, Bepantol® Derma Spray)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 (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma
  • 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 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

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
phase 4
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

January 28, 2019

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

BR(1)