ErythemaPhase 4NCT03853538
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering
A Phase 4 study testing BAY207543 (Bepanthol, Bepantol® Derma Spray) and Semisolid vaseline in people with Erythema and Skin Recovery, run by Bayer at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Erythema, Skin Recovery
- What is being tested?
- BAY207543 (Bepanthol, Bepantol® Derma Spray) and Semisolid vaseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Jan 2019to 6 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.
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.
Read the detailed description
The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-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.
- Conditions
- Erythema, Skin Recovery
- Being tested
- BAY207543 (Bepanthol, Bepantol® Derma Spray), Semisolid vaseline
- Keywords
- Dermal spray, Ablative lasering, Skin hydration, Consumer satisfaction, Sensorial perception
- Medical subject headings
- Erythema, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY207543 (Bepanthol, Bepantol® Derma Spray)Drug
Product is applied to one hemiface.
Semisolid vaselineOther
Product is applied to one hemiface.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss by TEWL probe
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Measured: Up to 23 days
Dermic temperature by thermographic camera (FLIR T530sc)
Measured: Up to 23 days
Secondary outcomes (7)
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 9 to 45 (a higher score represents higher efficacy).
Measured: Up to 23 days
Treatment satisfaction
Participants assess their treatment satisfaction with a questionnaire consisting of 13 items (each item is scored from 1-5) resulting in a score range of 13 to 65 (a higher score represents better treatment satisfaction).
Measured: Up to 23 days
Product evaluation
Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 6 items (each item is scored from 1-5) resulting in a score range from 6 to 30 (a higher score represents higher product satisfaction).
Measured: Up to 23 days
Number of adverse events by dermatological evaluation
Measured: Up to 23 days
Number of adverse events by ophthalmologic valuation
Measured: Up to 23 days
Severity of adverse events by dermatological evaluation
Measured: Up to 23 days
Severity of adverse events by ophthalmologic valuation
Measured: Up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start28 Jan 2019
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853538
- Sponsor's protocol ID
- 20505
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.
- ClinicalTrials.gov ID
- NCT03853538
- Acronym / sponsor ID
- 20505
- Conditions
- Erythema, Skin Recovery
- Keywords
- Dermal spray, Ablative lasering, Skin hydration, Consumer satisfaction, Sensorial perception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women_Hemiface BAY207543 | Experimental | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray), Other: Semisolid vaselineAdult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated. |
| Women_Hemiface Vaseline | Active comparator | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray), Other: Semisolid vaselineAdult 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY207543 (Bepanthol, Bepantol® Derma Spray)Product is applied to one hemiface. | Drug | Women_Hemiface BAY207543, Women_Hemiface Vaseline |
| Semisolid vaselineProduct is applied to one hemiface. | Other | Women_Hemiface BAY207543, Women_Hemiface Vaseline |
Primary outcome
Transepidermal water loss by TEWL probe
Time frame: Up to 23 days
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
Dermic temperature by thermographic camera (FLIR T530sc)
Time frame: Up to 23 days
7 secondary outcomes
Skin properties of the participants
Time frame: Up to 23 days
Treatment satisfaction
Time frame: Up to 23 days
Product evaluation
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BAY207543 (Bepanthol, Bepantol® Derma Spray) and Semisolid vaseline in people with Erythema and Skin Recovery, run by Bayer at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal water loss by TEWL probe (time frame: Up to 23 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.