Skin Alterations Associated With Atopic DermatitisPhase 2NCT01792713
Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis
A Phase 2 study testing Sertaconazole 2% cream in people with Skin Alterations Associated With Atopic Dermatitis, run by Spirig Pharma Ltd. at 2 sites in Germany.
Trial summary
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skin Alterations Associated With Atopic Dermatitis
- What is being tested?
- Sertaconazole 2% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2013to Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
- Atopic lesion localisation: arms; additional legs, neck
Who cannot join
- SCORAD > 40
- Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
- Active immunosuppression or cancer
- Narcotics- or Alcohol abuse
- Participation in another clinical trial until one month prior inclusion
- Known allergies against an ingredient of the investigational medicinal product
- Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
Berlin, 10117
Universitätsklinikum Münster, Klinik für Hautkrankheiten
Münster, 48149
About this study
Official title: Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis
- Being tested
- Sertaconazole 2% cream, Placebo
- Keywords
- Skin alterations, Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertaconazole 2% creamDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sertaconazole 2% cream | Active comparator | 2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up Receives: Drug: Sertaconazole 2% cream |
| Placebo Arm | Placebo comparator | 2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Global Assessment (PGA)
Measured: day 1, day 28
Secondary outcomes (3)
Change in Eczema Area and Severity Index (EASI)
Measured: day 1, day 28
Change in Dermatology Life Quality Index (DLQI)
Measured: d1, d28
Change in Patient Benefit Index (PBI)
Measured: day 1, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Alterations Associated With Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirig Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792713
- Sponsor's protocol ID
- E550-PRU-2012
- Other IDs
- 2012-003954-95
- Status last verified
- May 2015
- First submitted
- 13 Feb 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.
PubMed 26527564
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)
- ClinicalTrials.gov ID
- NCT01792713
- Acronym / sponsor ID
- E550-PRU-2012
- Keywords
- Skin alterations, Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Spirig Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Feb 2013 (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.
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertaconazole 2% cream | Active comparator | Drug: Sertaconazole 2% cream2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up |
| Placebo Arm | Placebo comparator | Drug: Placebo2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
- Atopic lesion localisation: arms; additional legs, neck
Key exclusion criteria (8 listed)
- SCORAD > 40
- Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
- Active immunosuppression or cancer
- Narcotics- or Alcohol abuse
- Participation in another clinical trial until one month prior inclusion
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 |
|---|---|---|
| Sertaconazole 2% cream | Drug | Sertaconazole 2% cream |
| Placebo | Drug | Placebo Arm |
Primary outcome
Change in Patient Global Assessment (PGA)
Time frame: day 1, day 28
3 secondary outcomes
Change in Eczema Area and Severity Index (EASI)
Time frame: day 1, day 28
Change in Dermatology Life Quality Index (DLQI)
Time frame: d1, d28
Change in Patient Benefit Index (PBI)
Time frame: day 1, day 28
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 20 May 2015.
- Derived from this study: PubMed 26527564Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sertaconazole 2% cream in people with Skin Alterations Associated With Atopic Dermatitis, run by Spirig Pharma Ltd. at 2 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 3 inclusion and 8 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
Change in Patient Global Assessment (PGA) (time frame: day 1, day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792713, which also lists 1 linked publication.
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 20 May 2015.