Dermatitis, AtopicNCT02615561
Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
A study testing Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543), New cosmetic Bepanthen product: Pumpkin (BAY207543) and Stelatopia (cosmetic comparator) in people with Dermatitis, Atopic, run by Bayer at 14 sites in Germany.
Trial summary
1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream). 2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543), New cosmetic Bepanthen product: Pumpkin (BAY207543) and Stelatopia (cosmetic comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 14 sitesGermany
- Study dates
- 15 Dec 2015to 7 Sep 2016
- Phase
- Interventional
- 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 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
- Male or female babies/children aged between 1 month and 4 years
- Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
- Acute flare-up phase
- Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
- Skin type I - IV according to Fitzpatrick
Who cannot join
- Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
- Known allergies to any of the ingredients of the IMPs
- Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
- Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Study site
Altdorf B. Nürnberg, Bavaria, 90518
Study site
Bochum, North Rhine-Westphalia, 44791
Study site
Bramsche, Lower Saxony, 49565
Study site
Datteln, North Rhine-Westphalia, 45711
Study site
Dortmund, North Rhine-Westphalia, 44143
Study site
Erfurt, Thuringia, 99086
Study site
Frankenthal, Rhineland-Palatinate, 67227
Study site
Karlsruhe, Baden-Wurttemberg, 76189
Study site
Kehl, Baden-Wurttemberg, 77694
Study site
Neumünster, Schleswig-Holstein, 24534
Study site
Neustadt / Aisch, Bavaria, 91413
Study site
Rosenheim, Bavaria, 83026
Study site
Schwäbisch Hall, Baden-Wurttemberg, 74523
Study site
Welzheim, Baden-Wurttemberg, 73642
About this study
Official title: Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis
- Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
- Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
- Conditions
- Dermatitis, Atopic
- Being tested
- Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543), New cosmetic Bepanthen product: Pumpkin (BAY207543), Stelatopia (cosmetic comparator)
- Keywords
- Safety, Efficacy, Atopic dermatitis, Cosmetic products
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)Device
2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares
New cosmetic Bepanthen product: Pumpkin (BAY207543)Other
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
Stelatopia (cosmetic comparator)Other
Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Cure phase) | Experimental | Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2) Receives: Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543) |
| Phase 2 (Care phase) / Arm 1 | Experimental | Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD Receives: Other: New cosmetic Bepanthen product: Pumpkin (BAY207543) |
| Phase 2 (Care phase) / Arm 2 | Active comparator | Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD Receives: Other: Stelatopia (cosmetic comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
Measured: up to 3 months
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Measured: up to 3 months
Efficacy: Quality of Life according to questionnaire
Measured: up to 3 months
Efficacy: Intensity of pruritus according to diary
Measured: up to 3 months
Efficacy: Intensity of sleeplessness according to diary
Measured: up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Measured: up to 3 months
Efficacy: Time to flare-up (Phase 2, only)
Measured: up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Measured: up to 3 months
Secondary outcomes (4)
Safety: Number of adverse events (AE)
Measured: up to 3 months
Safety: physical examination
Weight and height
Measured: up to 3 months
Safety: vital signs
Systolic and diastolic blood pressure, Heart rate
Measured: up to 3 months
Safety: Local tolerability (by AE assessment)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start15 Dec 2015
- Primary completion7 Sep 2016
- Study completion7 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615561
- Sponsor's protocol ID
- 17534
- Other IDs
- 2015-003485-92, 2015
- Status last verified
- Sep 2017
- First submitted
- 23 Oct 2015
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02615561
- Acronym / sponsor ID
- 17534
- Conditions
- Dermatitis, Atopic
- Keywords
- Safety, Efficacy, Atopic dermatitis, Cosmetic products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 7 Sep 2016 (actual)
- Study completion
- 7 Sep 2016 (actual)
- First posted
- 26 Nov 2015 (estimated)
- 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.
- Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream).
- Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (Cure phase) | Experimental | Device: Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2) |
| Phase 2 (Care phase) / Arm 1 | Experimental | Other: New cosmetic Bepanthen product: Pumpkin (BAY207543)Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD |
| Phase 2 (Care phase) / Arm 2 | Active comparator | Other: Stelatopia (cosmetic comparator)Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
- Male or female babies/children aged between 1 month and 4 years
- Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
- Acute flare-up phase
- Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
Key exclusion criteria (4 listed)
- Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
- Known allergies to any of the ingredients of the IMPs
- Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
- Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy 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 |
|---|---|---|
| Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares | Device | Phase 1 (Cure phase) |
| New cosmetic Bepanthen product: Pumpkin (BAY207543)Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject | Other | Phase 2 (Care phase) / Arm 1 |
| Stelatopia (cosmetic comparator)Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject | Other | Phase 2 (Care phase) / Arm 2 |
Primary outcome
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness
Time frame: up to 3 months
Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness
Time frame: up to 3 months
Efficacy: Quality of Life according to questionnaire
Time frame: up to 3 months
Efficacy: Intensity of pruritus according to diary
Time frame: up to 3 months
Efficacy: Intensity of sleeplessness according to diary
Time frame: up to 3 months
Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)
Time frame: up to 3 months
Efficacy: Time to flare-up (Phase 2, only)
Time frame: up to 3 months
Efficacy: Percent of subjects with flare-up (Phase 2, only)
Time frame: up to 3 months
4 secondary outcomes
Safety: Number of adverse events (AE)
Time frame: up to 3 months
Safety: physical examination
Time frame: up to 3 months
Safety: vital signs
Time frame: up to 3 months
Safety: Local tolerability (by AE assessment)
Time frame: up to 3 months
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 15 Sep 2017.
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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.
Bayer Study Director study director
Bayer
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543), New cosmetic Bepanthen product: Pumpkin (BAY207543) and Stelatopia (cosmetic comparator) in people with Dermatitis, Atopic, run by Bayer at 14 sites in Germany.
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 6 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. 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.
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?
Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness (time frame: up to 3 months). The study lists 8 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 15 Sep 2017.