Atopic DermatitisPhase 2Sinecort PilotNCT00980135
Sinecort Pilot Efficacy Study
A Phase 2 study testing Sinecort cream, Hydrocortison cream and Untreated skin in people with Atopic Dermatitis, run by Bayer at 1 site in Germany.
Trial summary
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Sinecort cream, Hydrocortison cream and Untreated skin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to May 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Caucasians aged between 18 and 65 years
- Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
- Skin type I - IV according to Fitzpatrick
- Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
- Acute symptom of pruritus at Baseline
Who cannot join
- Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
- Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
- Regular intake of antiphlogistic drugs (for example, NSAIDs)
- Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- UV-therapy or the use of solarium within 30 days before screening as well as during the trial
- Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-blind, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a New Topical Medical Device in Patients With Mild Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin.
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
- Conditions
- Atopic Dermatitis
- Being tested
- Sinecort cream, Hydrocortison cream, Untreated skin
- Keywords
- Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinecort creamDevice
Application over 29 days
Hydrocortison creamDrug
Application over 29 days
Untreated skinOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Device: Sinecort cream |
| Arm 2 | Experimental | Not described Receives: Drug: Hydrocortison cream |
| Arm 3 | Other | Not described Receives: Other: Untreated skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy rate versus comparator and untreated skin
Measured: After 29 days of twice daily applications
Local side effects on the skin
Measured: 29 days
Secondary outcomes (8)
Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6
Measured: after 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
Measured: after 29 days
Skin hydration by means of corneometry at visit 2 through visit 6
Measured: after 29 days
Erythema by means of chromametry at Visit 2 through Visit 6
Measured: after 29 days
Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)
Measured: after 29 days
Incidence and severity of Adverse Event
Measured: visit 2 (start of dosing period) till 6 weeks after end of treatment
Vital signs
Measured: visit1 and 6 weeks after end of treatment
Local side effects
Measured: visit 2 (start of dosing period) till 6 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT00980135
- Sponsor's protocol ID
- 13932
- Other IDs
- 2008-008136-82, 2008
- Acronym
- Sinecort Pilot
- Status last verified
- Apr 2014
- First submitted
- 16 Sep 2009
- Last updated
- 2 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-blind, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a New Topical Medical Device in Patients With Mild Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin.
- ClinicalTrials.gov ID
- NCT00980135
- Acronym / sponsor ID
- Sinecort Pilot / 13932
- Conditions
- Atopic Dermatitis
- Keywords
- Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Sep 2009 (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.
The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Sinecort cream |
| Arm 2 | Experimental | Drug: Hydrocortison cream |
| Arm 3 | Other | Other: Untreated skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female Caucasians aged between 18 and 65 years
- Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
- Skin type I - IV according to Fitzpatrick
- Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
- Acute symptom of pruritus at Baseline
Key exclusion criteria (6 listed)
- Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
- Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
- Regular intake of antiphlogistic drugs (for example, NSAIDs)
- Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
- UV-therapy or the use of solarium within 30 days before screening as well as during the trial
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 |
|---|---|---|
| Sinecort creamApplication over 29 days | Device | Arm 1 |
| Hydrocortison creamApplication over 29 days | Drug | Arm 2 |
| Untreated skin | Other | Arm 3 |
Primary outcome
Efficacy rate versus comparator and untreated skin
Time frame: After 29 days of twice daily applications
Local side effects on the skin
Time frame: 29 days
8 secondary outcomes
Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6
Time frame: after 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
Time frame: after 29 days
Skin hydration by means of corneometry at visit 2 through visit 6
Time frame: after 29 days
Erythema by means of chromametry at Visit 2 through Visit 6
Time frame: after 29 days
Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)
Time frame: after 29 days
Incidence and severity of Adverse Event
Time frame: visit 2 (start of dosing period) till 6 weeks after end of treatment
Vital signs
Time frame: visit1 and 6 weeks after end of treatment
Local side effects
Time frame: visit 2 (start of dosing period) till 6 weeks after end of treatment
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 2 Apr 2014.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sinecort cream, Hydrocortison cream and Untreated skin in people with Atopic Dermatitis, run by Bayer at 1 site 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 5 inclusion and 6 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 2 Apr 2014. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy rate versus comparator and untreated skin (time frame: After 29 days of twice daily applications). 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 2 Apr 2014.