Dermatitis, AtopicPhase 1NCT02411162
A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
A Phase 1 study testing Combination therapy GSK2894512 Cream A + GSK2894512 Cream B in people with Dermatitis, Atopic, run by Stiefel, a GSK Company at 1 site in United States.
Trial summary
This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Combination therapy GSK2894512 Cream A + GSK2894512 Cream B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2015to 24 Sep 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Skin tone in the potential test site on the forearm such that erythema and other dermal reactions can be easily visualized, i.e. only Fitzpatrick skin types I (always burns; never tans), II (usually burns; tans with difficulty), III (sometimes mild burn; gradually tans), or IV (rarely burns; tans with ease) will be included. Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrolment.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Who cannot join
- Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Corrected QT interval (QTc) >450 milliseconds (msec)
- Concurrent conditions and history of diseases: Immunocompromized (eg, lymphoma, acquired immune deficiency syndrome (AIDS), Wiskott-Aldrich Syndrome or have a history of malignant disease within 5 years before the baseline visit, with the exception of basal and squamous cell cancers; Active acute bacterial, fungal or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox); Any other concomitant skin disorder (e.g., generalized erythroderma such as Netherton's Syndrome, atopic dermatitis or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the test site evaluation or contraindicate participation; clinical signs of infection (viral, fungal or bacterial) within the treatment areas; other types of skin disease that may impact evaluation.
- Inability to evaluate the skin at and around the potential test sites on the forearms due to sunburn, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
- Chronic or acute infection requiring treatment with systemic antibiotics, anti-virals, anti-parasitics, anti-protozoals, or anti-fungals within 4 weeks before the baseline visit, or superficial skin infections within 1 week before the screening visit.
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- Planning a significant exposure to ultraviolet (UV) radiation (sun-bathing or tanning).
- Planning to use a sauna during the duration of the study or intending to swim more than once a week.
- Participation in a clinical drug or device research study within the previous 30 days.
- History of sensitivity to any of the study medications, local anesthesia, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Concomitant Medications: Investigational products and topical medications or products (including but not limited to self-tanning products, waxing products, benzoyl peroxide, salicylic acid, or sulphur) in the areas of testing.
- Contraindications: History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. . For potent immunosuppressive agents, subjects with presence of hepatitis B core antibody (HBcAb) should also be excluded.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers
This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).
- Conditions
- Dermatitis, Atopic
- Being tested
- Combination therapy GSK2894512 Cream A + GSK2894512 Cream B, Combination therapy Vehicle Cream A + Vehicle Cream B
- Keywords
- atopic dermatitis, FLIM, chronic plaque psoriasis, healthy volunteers, GSK2894512, Skin residency
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy GSK2894512 Cream A + GSK2894512 Cream BDrug
GSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm^2 of skin.
Combination therapy Vehicle Cream A + Vehicle Cream BDrug
Vehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Experimental | In Cohort 1, study medication (Cream A, 1%) will be applied as a thin layer onto a predefined area of the volar region of the forearm that is large enough to image and collect 3 biopsies (4 mm per biopsy). Vehicle will be applied on Day 1 only, onto a symmetrical location on the opposite forearm from Cream A. In cohort 2, subjects will be enrolled to evaluate Cream A (1%) and a different GSK2894512 Cream, Cream B (1%). Cream A, 1% and Cream B, 1% will be applied as a thin layer to the opposite forearms of the subject. Vehicle will be applied only on Day 1 to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied. Both Cream A and Cream B will continue to be applied OD to the same area of the same forearm for 7 days. Receives: Drug: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B; Drug: Combination therapy Vehicle Cream A + Vehicle Cream B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residence time in skin following topical application of two formulations of GSK2894512 Cream
Fluorescent lifetime imaging microscopy (FLIM) images will be evaluated to determine if GSK2894512 is detectable in skin. Drug concentrations can be quantified considering the: depth of penetration at each time point and the amount of fluorescence detected. Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) will also be used to measure the concentration of GSK2894512 from biopsies.
Measured: Up to Day 15
Secondary outcomes (6)
Adverse events (AEs) monitoring after two formulations of GSK2894512 cream
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity, or; is a congenital anomaly/birth defect.
Measured: Up to Day 15
Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream
Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate
Measured: Up to Day 15
Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream
Single 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval for Bazett's formula (QTcB) intervals
Measured: Up to Day 15
Composite of abbreviated physical examination after two formulations of GSK2894512 cream
Physical examination will include, at a minimum assessments of Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. Height and weight will also be measured and recorded
Measured: Up to Day 15
Laboratory assessments after two formulations of GSK2894512 cream
Laboratory assessments including haematology, clinical chemistry, and urinalysis
Measured: Up to Day 15
Local tolerability assessments after two formulations of GSK2894512 cream
Tolerability will be evaluated on the basis of degree of local irritation.
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study start7 Jul 2015
- Primary completion24 Sep 2015
- Study completion24 Sep 2015
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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiefel, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411162
- Sponsor's protocol ID
- 201661
- Status last verified
- May 2017
- First submitted
- 6 Mar 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02411162
- Acronym / sponsor ID
- 201661
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, FLIM, chronic plaque psoriasis, healthy volunteers, GSK2894512, Skin residency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 24 Sep 2015 (actual)
- Study completion
- 24 Sep 2015 (actual)
- First posted
- 8 Apr 2015 (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 will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Experimental | Drug: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B, Drug: Combination therapy Vehicle Cream A + Vehicle Cream BIn Cohort 1, study medication (Cream A, 1%) will be applied as a thin layer onto a predefined area of the volar region of the forearm that is large enough to image and collect 3 biopsies (4 mm per biopsy). Vehicle will be applied on Day 1 only, onto a symmetrical location on the opposite forearm from Cream A. In cohort 2, subjects will be enrolled to evaluate Cream A (1%) and a different GSK2894512 Cream, Cream B (1%). Cream A, 1% and Cream B, 1% will be applied as a thin layer to the opposite forearms of the subject. Vehicle will be applied only on Day 1 to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied. Both Cream A and Cream B will continue to be applied OD to the same area of the same forearm for 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males, between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Skin tone in the potential test site on the forearm such that erythema and other dermal reactions can be easily visualized, i.e. only Fitzpatrick skin types I (always burns; never tans), II (usually burns; tans with difficulty), III (sometimes mild burn; gradually tans), or IV (rarely burns; tans with ease) will be included. Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with values outside the normal range should always be excluded from enrolment.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Key exclusion criteria (17 listed)
- Alanine aminotransferase (ALT) and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Corrected QT interval (QTc) >450 milliseconds (msec)
- Concurrent conditions and history of diseases: Immunocompromized (eg, lymphoma, acquired immune deficiency syndrome (AIDS), Wiskott-Aldrich Syndrome or have a history of malignant disease within 5 years before the baseline visit, with the exception of basal and squamous cell cancers; Active acute bacterial, fungal or viral skin infection (e.g., herpes simplex, herpes zoster, chicken pox); Any other concomitant skin disorder (e.g., generalized erythroderma such as Netherton's Syndrome, atopic dermatitis or psoriasis), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the test site evaluation or contraindicate participation; clinical signs of infection (viral, fungal or bacterial) within the treatment areas; other types of skin disease that may impact evaluation.
- Inability to evaluate the skin at and around the potential test sites on the forearms due to sunburn, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
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 |
|---|---|---|
| Combination therapy GSK2894512 Cream A + GSK2894512 Cream BGSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm^2 of skin. | Drug | Open Label Arm |
| Combination therapy Vehicle Cream A + Vehicle Cream BVehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied. | Drug | Open Label Arm |
Primary outcome
Residence time in skin following topical application of two formulations of GSK2894512 Cream
Time frame: Up to Day 15
Fluorescent lifetime imaging microscopy (FLIM) images will be evaluated to determine if GSK2894512 is detectable in skin. Drug concentrations can be quantified considering the: depth of penetration at each time point and the amount of fluorescence detected. Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) will also be used to measure the concentration of GSK2894512 from biopsies.
6 secondary outcomes
Adverse events (AEs) monitoring after two formulations of GSK2894512 cream
Time frame: Up to Day 15
Composite of vital signs assessment including temperature, systolic and diastolic blood pressure and pulse rate of two formulations after two GSK2894512 cream
Time frame: Up to Day 15
Electrocardiogram (ECG) assessment after two formulations of GSK2894512 cream
Time frame: Up to Day 15
Composite of abbreviated physical examination after two formulations of GSK2894512 cream
Time frame: Up to Day 15
Laboratory assessments after two formulations of GSK2894512 cream
Time frame: Up to Day 15
Local tolerability assessments after two formulations of GSK2894512 cream
Time frame: Up to Day 15
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 9 May 2017.
- Results for study 201661 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 Combination therapy GSK2894512 Cream A + GSK2894512 Cream B in people with Dermatitis, Atopic, run by Stiefel, a GSK Company at 1 site in United States.
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 17 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 9 May 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 United States. 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?
Residence time in skin following topical application of two formulations of GSK2894512 Cream (time frame: Up to Day 15). 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 9 May 2017.