Dermatitis, AtopicPhase 1NCT01381445
A Study Assessing GW870086's Potential to Cause Skin Thinning
A Phase 1 study testing GW870086 0.2%, GW870086 2% and Clobetasol Propionate in people with Dermatitis, Atopic, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- GW870086 0.2%, GW870086 2% and Clobetasol Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 14 Apr 2011to 7 Jul 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal)(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by an experienced physician.
- Male or female between 18 and 55 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
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- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Capable of giving written informed consent.
- Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Who cannot join
- Any sign of weak or fragile skin, striae, or similar, in the areas which will be evaluated.
- Tattoos or body art on the upper arms.
- Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to direct sunlight or skin tanning devices (e.g. sunbed) for the duration of the study.
- A positive pre-study test for Hepatitis B or Hepatitis C antibody within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- A positive pre-study drug/alcohol screen.
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- A positive test for HIV (Human Immunodeficiency Virus) antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications or components thereof.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Subjects who are kept due to regulatory or juridical order in an institution.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.
Read the detailed description
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. The primary objective of this study is to assess the thickness of the skin using ultrasound. The secondary objectives are to assess skin thinning using a visual scale for skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the pharmacokinetics of GW870086 administered as a cream for 42±2 days.
Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream. They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day treatment period. However subjects who are randomised to receive the unblinded clobetasol propionate will only apply this once daily for a maximum of 21±2 days but will continue to dose with the other 2 treatments. If significant evidence of skin thinning is observed in any of the treatment arms (25% reduction in skin thickness measured using ultrasound) then application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on the arm will be identified and each treatment will be applied to the same area throughout the 42±2 day treatment period.
- Conditions
- Dermatitis, Atopic
- Being tested
- GW870086 0.2%, GW870086 2%, Clobetasol Propionate, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW870086 0.2%Drug
White to slightly coloured opaque cream
GW870086 2%Drug
White to slightly coloured opaque cream
Clobetasol PropionateDrug
White cream
PlaceboDrug
White to slightly coloured opaque cream
| Study group | Role | What they receive |
|---|---|---|
| GW870086 0.2% & GW870086 2% | Experimental | GW870086 0.2%, 2% \& placebo each applied to an identified area for 42 days. Receives: Drug: GW870086 0.2%; Drug: GW870086 2%; Drug: Placebo |
| GW870086 2% & Clobetasol Propionate | Experimental | GW870086 2% \& placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days Receives: Drug: GW870086 2%; Drug: Clobetasol Propionate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Measured: Days; 1, 14, 21, 28, 42, 43
Secondary outcomes (6)
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Measured: Days; 7, 14, 21, 28, 35, 42, 43
The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Measured: 6 weeks
Plasma concentrations of GW870086
Measured: Days 14 & 42
Cmax of GW870086
Measured: Days 14 & 42
Tmax of GW870086
Measured: Days 14 & 42
AUC of GW870086
Measured: Days 14 & 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start14 Apr 2011
- Primary completion7 Jul 2011
- Study completion7 Jul 2011
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT01381445
- Sponsor's protocol ID
- 113435
- Status last verified
- Jul 2017
- First submitted
- 16 Jun 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind (for GW870086), Placebo-controlled Study of Topical GW870086 Formulation to Explore the Potential for Skin Thinning in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01381445
- Acronym / sponsor ID
- 113435
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2011 (actual)
- Primary completion
- 7 Jul 2011 (actual)
- Study completion
- 7 Jul 2011 (actual)
- First posted
- 27 Jun 2011 (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.
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.
Detailed description
This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. The primary objective of this study is to assess the thickness of the skin using ultrasound. The secondary objectives are to assess skin thinning using a visual scale for skin atrophy and telangiectasia, safety and tolerability of GW870086 and to assess the pharmacokinetics of GW870086 administered as a cream for 42±2 days.
Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream. They will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream. Subjects will apply all 3 treatments once daily during the 42±2 day treatment period. However subjects who are randomised to receive the unblinded clobetasol propionate will only apply this once daily for a maximum of 21±2 days but will continue to dose with the other 2 treatments. If significant evidence of skin thinning is observed in any of the treatment arms (25% reduction in skin thickness measured using ultrasound) then application of this treatment will be discontinued. Three areas of approximately 5 x 5 cm on the arm will be identified and each treatment will be applied to the same area throughout the 42±2 day treatment period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GW870086 0.2% & GW870086 2% | Experimental | Drug: GW870086 0.2%, Drug: GW870086 2%, Drug: PlaceboGW870086 0.2%, 2% \& placebo each applied to an identified area for 42 days. |
| GW870086 2% & Clobetasol Propionate | Experimental | Drug: GW870086 2%, Drug: Clobetasol Propionate, Drug: PlaceboGW870086 2% \& placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal)(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Healthy as determined by an experienced physician.
- Male or female between 18 and 55 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
Key exclusion criteria (18 listed)
- Any sign of weak or fragile skin, striae, or similar, in the areas which will be evaluated.
- Tattoos or body art on the upper arms.
- Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to direct sunlight or skin tanning devices (e.g. sunbed) for the duration of the study.
- A positive pre-study test for Hepatitis B or Hepatitis C antibody within 3 months of screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
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 |
|---|---|---|
| GW870086 0.2%White to slightly coloured opaque cream | Drug | GW870086 0.2% & GW870086 2% |
| GW870086 2%White to slightly coloured opaque cream | Drug | GW870086 0.2% & GW870086 2%, GW870086 2% & Clobetasol Propionate |
| Clobetasol PropionateWhite cream | Drug | GW870086 2% & Clobetasol Propionate |
| PlaceboWhite to slightly coloured opaque cream | Drug | GW870086 0.2% & GW870086 2%, GW870086 2% & Clobetasol Propionate |
Primary outcome
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Time frame: Days; 1, 14, 21, 28, 42, 43
6 secondary outcomes
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Time frame: Days; 7, 14, 21, 28, 35, 42, 43
The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Time frame: 6 weeks
Plasma concentrations of GW870086
Time frame: Days 14 & 42
Cmax of GW870086
Time frame: Days 14 & 42
Tmax of GW870086
Time frame: Days 14 & 42
AUC of GW870086
Time frame: Days 14 & 42
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 21 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 113435 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GW870086 0.2%, GW870086 2% and Clobetasol Propionate 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 9 inclusion and 18 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 21 Jul 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?
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo (time frame: Days; 1, 14, 21, 28, 42, 43). 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 21 Jul 2017.