Skin RecoveryPhase 4NCT03853512
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women
A Phase 4 study testing BAY207543 (Bepanthol, Bepantol® Derma Spray) and Semisolid vaseline in people with 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 after a dermatological procedure (peeling) in the intimate area of women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 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
- 12 Feb 2019to 13 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Phototypes I and II according to the Fitzpatrick scale;
- Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.
Who cannot join
- Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
- Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
- Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, 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 after peeling in the female intima and inguinal region.
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
- Skin Recovery
- Being tested
- BAY207543 (Bepanthol, Bepantol® Derma Spray), Semisolid vaseline
- Keywords
- Dermal spray, Peeling, Skin hydration, Consumer satisfaction, Sensorial perception
- Medical subject headings
- 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 side of the inguinal region.
Semisolid vaselineOther
Product is applied to the other side of the inguinal region.
| Study group | Role | What they receive |
|---|---|---|
| Women_Inguinal side BAY207543 | Experimental | Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated. Receives: Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray); Other: Semisolid vaseline |
| Women_Inguinal side Vaseline | Active comparator | Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be 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
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 12 to 60 (a higher score represents higher efficacy).
Measured: Up to 23 days
Treatment satisfaction
Participants assess their treatment satisfaction with a questionnaire consisting of 19 items (each item is scored from 1-5) resulting in a score range of 19 to 95 (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 gynecological evaluation
Measured: Up to 23 days
Severity of adverse events by dermatological evaluation
Measured: Up to 23 days
Severity of adverse events by gynecological evaluation
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 start12 Feb 2019
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RecoveryStudies 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
- NCT03853512
- Sponsor's protocol ID
- 20507
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2019
- Last updated
- 11 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
- ClinicalTrials.gov ID
- NCT03853512
- Acronym / sponsor ID
- 20507
- Conditions
- Skin Recovery
- Keywords
- Dermal spray, Peeling, 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
- 12 Feb 2019 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 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 after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, 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 after peeling in the female intima and inguinal region.
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_Inguinal side BAY207543 | Experimental | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray), Other: Semisolid vaselineAdult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated. |
| Women_Inguinal side Vaseline | Active comparator | Drug: BAY207543 (Bepanthol, Bepantol® Derma Spray), Other: Semisolid vaselineAdult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Phototypes I and II according to the Fitzpatrick scale;
- Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.
Key exclusion criteria (3 listed)
- Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
- Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
- Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
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 side of the inguinal region. | Drug | Women_Inguinal side BAY207543, Women_Inguinal side Vaseline |
| Semisolid vaselineProduct is applied to the other side of the inguinal region. | Other | Women_Inguinal side BAY207543, Women_Inguinal side 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.
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 gynecological evaluation
Time frame: Up to 23 days
Severity of adverse events by dermatological evaluation
Time frame: Up to 23 days
Severity of adverse events by gynecological evaluation
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 11 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 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 2 inclusion and 3 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 11 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). 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 11 Mar 2020.