Dermatitis, AtopicPhase 1NCT00356642
Study Of Single And Ten Day Repeat Atopical Applications Of GW842470X Cream On The Skin Of Patients With Atopic Dermatitis
A Phase 1 study testing GW842470X in people with Dermatitis, Atopic, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4). Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- GW842470X
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jun 2005to 21 Dec 2005
- Phase
- Phase 1
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
- BMI range 18.5-29.9m2 at least 2 index lesions and BSA involvement >10%.
- 14 day washout of current therapy.
Who cannot join
- Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone.
- Patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis
The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).
- Conditions
- Dermatitis, Atopic
- Being tested
- GW842470X, Placebo
- Keywords
- PK, GW842470X, safety, tolerability, PD, 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.
GW842470XDrug
GW842470X will be available as a yellow smooth water-in-oil cream.
PlaceboDrug
GW842470X matching placebo will be available as a yellow smooth water-in-oil cream.
| Study group | Role | What they receive |
|---|---|---|
| Single dose 1 cohort | Experimental | Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1. Receives: Drug: GW842470X; Drug: Placebo |
| Repeat dose 1 cohort | Experimental | Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1 Receives: Drug: GW842470X; Drug: Placebo |
| Repeat dose 2 cohort | Experimental | Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1 Receives: Drug: GW842470X; Drug: Placebo |
| Repeat dose 3 cohort | Experimental | Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1 Receives: Drug: GW842470X; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal physical examination findings
Measured: Up to Day 22
Number of subjects with abnormal blood pressure
Measured: Up to Day 22
Number of subjects with abnormal heart rate
Measured: Up to Day 22
Number of subjects with abnormal 12-lead ECG assessment
Measured: Up to Day 22
Number of subjects with abnormal findings on lead II cardiac monitoring
Measured: Up to Day 10
Number of subjects with abnormal clinical laboratory tests
Measured: Up to Day 22
AUC
Measured: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Cmax
Measured: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Secondary outcomes (6)
Time to max concentration and terminal half-life
Measured: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
SCORAD
Measured: Up to Day 10
BSA determination
Measured: Up to Day 10
clinical photography
Measured: Up to Day 10
measurement of barrier function using trans-epidermal water loss (TEWL)
Measured: Up to Day 10
skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study start10 Jun 2005
- Primary completion21 Dec 2005
- Study completion21 Dec 2005
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 Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356642
- Sponsor's protocol ID
- TPD102031
- Status last verified
- Sep 2017
- First submitted
- 25 Jul 2006
- Last updated
- 29 Sep 2017
- Results posted
- No
Publications
Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015 Jan 23;10:185-92. doi: 10.2147/COPD.S74557. eCollection 2015.
PubMed 25670894
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00356642
- Acronym / sponsor ID
- TPD102031
- Conditions
- Dermatitis, Atopic
- Keywords
- PK, GW842470X, safety, tolerability, PD, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2005 (actual)
- Primary completion
- 21 Dec 2005 (actual)
- Study completion
- 21 Dec 2005 (actual)
- First posted
- 26 Jul 2006 (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 purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single dose 1 cohort | Experimental | Drug: GW842470X, Drug: PlaceboSubjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1. |
| Repeat dose 1 cohort | Experimental | Drug: GW842470X, Drug: PlaceboSubjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1 |
| Repeat dose 2 cohort | Experimental | Drug: GW842470X, Drug: PlaceboSubjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1 |
| Repeat dose 3 cohort | Experimental | Drug: GW842470X, Drug: PlaceboSubjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1 |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atopic dermatitis patients (moderate to severe) who are otherwise healthy.
- BMI range 18.5-29.9m2 at least 2 index lesions and BSA involvement >10%.
- 14 day washout of current therapy.
Key exclusion criteria (2 listed)
- Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar or any treatment with corticosteroids within 14 days prior to first application except 1% hydrocortisone.
- Patients must not present with any systemic disorders or active skin disease other than atopic dermatitis.
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 |
|---|---|---|
| GW842470XGW842470X will be available as a yellow smooth water-in-oil cream. | Drug | Repeat dose 1 cohort, Repeat dose 2 cohort, Repeat dose 3 cohort, Single dose 1 cohort |
| PlaceboGW842470X matching placebo will be available as a yellow smooth water-in-oil cream. | Drug | Repeat dose 1 cohort, Repeat dose 2 cohort, Repeat dose 3 cohort, Single dose 1 cohort |
Primary outcome
Number of subjects with abnormal physical examination findings
Time frame: Up to Day 22
Number of subjects with abnormal blood pressure
Time frame: Up to Day 22
Number of subjects with abnormal heart rate
Time frame: Up to Day 22
Number of subjects with abnormal 12-lead ECG assessment
Time frame: Up to Day 22
Number of subjects with abnormal findings on lead II cardiac monitoring
Time frame: Up to Day 10
Number of subjects with abnormal clinical laboratory tests
Time frame: Up to Day 22
AUC
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Cmax
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
6 secondary outcomes
Time to max concentration and terminal half-life
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
SCORAD
Time frame: Up to Day 10
BSA determination
Time frame: Up to Day 10
clinical photography
Time frame: Up to Day 10
measurement of barrier function using trans-epidermal water loss (TEWL)
Time frame: Up to Day 10
skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)
Time frame: Up to Day 10
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 29 Sep 2017.
- Derived from this study: PubMed 25670894Ishikawa N, Hattori N, Kohno N, Kobayashi A, Hayamizu T, Johnson M. Airway inflammation in Japanese COPD patients compared with smoking and nonsmoking controls. Int J Chron Obstruct Pulmon Dis. 2015 Jan 23;10:185-92. doi: 10.2147/COPD.S74557. eCollection 2015.
- Results for study 102031 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW842470X in people with Dermatitis, Atopic, run by GlaxoSmithKline 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 3 inclusion and 2 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 29 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of subjects with abnormal physical examination findings (time frame: Up to Day 22). 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?
On the ClinicalTrials.gov record for NCT00356642, 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 29 Sep 2017.