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Atopic DermatitisPhase 2NCT01856764

Topical Roflumilast in Adults With Atopic Dermatitis

A Phase 2 study testing 0.5% Roflumilast Cream in people with Atopic Dermatitis, run by AstraZeneca at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis. 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?
0.5% Roflumilast Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
3 sitesGermany
Study dates
Jun 2013to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Is male or female between 18 to 65 years of age, inclusive, with atopic dermatitis (AD) meeting Hanifin and Rajka's criteria.
  • Has lesional skin areas of moderate severity characterized by modified local SCORing Atopic Dermatitis (SCORAD) of at least 4, with an erythema score ≥2, and confirmed by a qualified investigator.
  • Has an index/target lesion of moderate severity approximately 20 cm^2, suitable for topical treatment.
  • Is willing to wash out from AD current active therapy prior to entry in the study.
  • Is willing and able to apply the study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
  • If a male who is nonsterilized and sexually active with a female partner of childbearing potential, agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
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  • If a female of childbearing potential who is sexually active with a nonsterilized male partner, agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
  • Is capable of understanding and complying with protocol requirements in the opinion of the investigator.
  • Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Who cannot join

  • Has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening visit.
  • Has a history of AD unresponsive or poorly responsive to topical treatments.
  • Has a history of hypersensitivity to phosphodiesterase (PDE)-4 inhibitors or to drugs of similar chemical classes or any inactive ingredients of the trial medication.
  • Has clinically significant abnormal hematological parameters of hemoglobin, hematocrit or erythrocytes at Screening, in the judgment of the investigator.
  • Has a history or current clinically relevant allergy or idiosyncrasy to drugs or food.
  • Had extensive exposure to ultraviolet (UV) light in the 4 weeks prior to first application of study medication, including tanning and sun beds or is intending to have such exposure during the study treatment that may interfere with the study assessments as judged by the investigator.
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  • Has evidence of oozing of target lesion.
  • Has a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated.
  • Had systemic treatment with corticosteroids or retinoids for studied condition within 3 months prior to the first application of study medication.
  • Had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 4 weeks prior to first application of study medication.
  • Had treatment with systemic/locally acting medications/procedures that might counter or influence the study aim within 4 weeks prior to first application of study medication and during the study (e.g., anti-histamines).
  • Has used emollients/moisturizers on areas to be treated within 24 hours prior to the first application of study medication.
  • Has used biologics at any time for treatment of AD.
  • Is currently enrolled in an investigational drug or device study.
  • Has any clinically significant illness that may influence the outcome of the trial from 4 weeks before Day 1 through trial completion.
  • Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 × upper limit of normal (ULN), or other clinically significant abnormal laboratory test that, in the opinion of the Investigator, would compromise the participant's ability to safely complete the trial.
  • Has a significant medical condition and/or conditions that, in the opinion of the Investigator, would interfere with the treatment, safety or compliance with the protocol.
  • Has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
  • Has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming >14 alcoholic drinks per week.
  • If female, is pregnant, nursing or planning a pregnancy during the study period.
  • Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study medication. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin.
  • Has a chronic or clinically relevant acute infection.
  • Has a history of depression associated with suicidal ideation and behavior.
  • Has hemodynamically significant cardiac arrhythmias or heart valve deformations.
  • Is an immediate family member, a study site employee, in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or at risk for consenting under duress.
  • Was institutionalized because of a legal or regulatory order.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Study site

    Berlin

  • Study site

    Gera

  • Study site

    Hamburg

Other trials in Germany

About this study

Official title: A Phase 2a, 15-Day, Randomized, Parallel Group, Double-Blind, Multi-Centre, Vehicle Controlled Trial to Assess the Efficacy and Local Safety of a Cream Containing 0.5% Roflumilast - a Phosphodiesterase Type 4 Inhibitor (PDE4i) Dermal Formulation - on Atopic Dermatitis Patients With Skin Lesions of Moderate Severity

The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.

Being tested
0.5% Roflumilast Cream, Vehicle Cream
Keywords
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.

  • 0.5% Roflumilast CreamDrug

    Roflumilast 0.5% cream

  • Vehicle CreamDrug

    Roflumilast formulation vehicle

Study groups in NCT01856764
Study groupRoleWhat they receive
0.5% Roflumilast CreamExperimentalRoflumilast 0.5%, cream, topically, twice daily for up to 15 days.
Receives: Drug: 0.5% Roflumilast Cream
Vehicle CreamPlacebo comparatorRoflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Receives: Drug: Vehicle Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)

    Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.

    Measured: Baseline and Day 15

Secondary outcomes (2)

  1. Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values

    Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.

    Measured: Baseline and Day 15

  2. Change From Baseline to Day 15 in Participants' Assessment of Pruritus

    Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.

    Measured: Baseline and Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856764
Sponsor's protocol ID
ROF-DERM_203
Other IDs
2012-003000-12, U1111-1133-6455
Status last verified
Sep 2016
First submitted
14 May 2013
Last updated
1 Feb 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 0.5% Roflumilast Cream in people with Atopic Dermatitis, run by AstraZeneca at 3 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 9 inclusion and 26 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 7 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD) (time frame: Baseline and Day 15). 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 NCT01856764.

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 1 Feb 2017.

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