PsoriasisPhase 1NCT01984775
A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects
A Phase 1 study testing GSK2894512 cream in people with Psoriasis, run by Stiefel, a GSK Company at 2 sites in 2 countries.
Trial summary
This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- GSK2894512 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Oct 2013to 2 Jul 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years, inclusive, at time of consent.
- In generally good overall health with healthy skin in the potential test sites on the back.
- Skin tone in the potential test sites on the back such that erythema and other dermal reactions can be easily visualized, i.e., 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). Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure.
- A woman is eligible to participate if she is of non-childbearing potential, defined as a woman with functioning ovaries who has a documented bilateral tubal ligation/sterilization or hysterectomy, bilateral oopherectomy, or postmenopausal with at least 12 months of spontaneous amenorrhea.
Who cannot join
- History of known or suspected intolerance to GSK2894512, any of the ingredients of the study products, adhesive tape/plaster, or the test chambers.
- Inability to evaluate the skin at and around the potential test sites on the back due to sunburns, unevenness in skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
- Clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations.
- Considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk.
- Used prohibited concomitant medications or products within the defined washout periods before the Day 1 visit. This includes investigational products, allergy injections, immunizations, corticosteroids, immunomodulators, anti-inflammatories, antihistamines, selective leukotriene receptor antagonists, mast cell stabilizers, and topical medications or products at and around the potential test sites.
- Participation in any interventional clinical study within 4 weeks of the Day 1 Visit.
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- A clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- Considered vulnerable (e.g., individuals in detention/institutionalized due to legal or regulatory order).
- Employee of the study center, bioskin GmbH, Parexel, GlaxoSmithKline (GSK), or Stiefel who is involved in the study, or an immediate family member (e.g., partner, offspring, parents, siblings, or sibling's offspring) of an employee who is involved in the study.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
- QTc >=450 millisecond (msec) or QTc >=480 msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine overread. The QTc should be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Evaluator-Blinded Study to Evaluate the Cumulative Irritation Potential of Topically-Applied GSK2894512 Cream in Healthy Subjects
This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Results from this study will be considered when selecting the concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30 evaluable subjects complete the study. The total duration of subject participation may be up to 50 days.
- Conditions
- Psoriasis
- Being tested
- GSK2894512 cream, Vehicle cream, Positive control, Negative control
- Keywords
- safety, dermal, GSK2894512, Cumulative irritation
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2894512 creamDrug
GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% [5 milligram (mg)/gram (g)], 1% [10 mg/g], and 2% [20 mg/g]).
Vehicle creamDrug
Vehicle cream does not contain any active pharmaceutical ingredient.
Positive controlDrug
Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).
Negative controlDrug
Negative control contains petrolatum.
| Study group | Role | What they receive |
|---|---|---|
| GSK2894512 0.5% | Experimental | Each subject will receive a topical application of GSK2894512 0.5% under semi-occlusive patch conditions once daily (OD) for 21 days. Receives: Drug: GSK2894512 cream |
| GSK2894512 1% | Experimental | Each subject will receive a topical application of GSK2894512 1% under semi- occlusive patch conditions OD for 21 days. Receives: Drug: GSK2894512 cream |
| GSK2894512 2% | Experimental | Each subject will receive a topical application of GSK2894512 2% under semi-occlusive patch conditions OD for 21 days. Receives: Drug: GSK2894512 cream |
| Vehicle | Placebo comparator | Each subject will receive a topical application of Vehicle cream under semi-occlusive patch conditions OD for 21 days. Receives: Drug: Vehicle cream |
| Sodium lauryl sulfate 0.1% | Active comparator | Each subject will receive a topical application of 0.2 milliliter (mL) of Sodium lauryl sulfate under semi-occlusive patch conditions OD for 21 days. This will serve as a positive control. Receives: Drug: Positive control |
| Petrolatum | Active comparator | Each subject will receive a topical application of 0.2 mL of Petrolatum under semi-occlusive patch conditions OD for 21 days. This will serve as a negative control. Receives: Drug: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cumulative irritation score
It is the sum of dermal response irritation scores from Day 2 through Day 22 divided by the number of non-missing observations
Measured: 21 Days
Total cumulative irritation score
It is the sum of dermal response irritation scores from Day 2 through Day 22
Measured: 21 Days
Secondary outcomes (5)
Incidence of adverse events (AEs) and treatment-related AEs
All AEs and serious adverse events will be collected from the time a subject consents to participate in the study through the final study visit
Measured: Up to Day 22
Change from baseline in vital signs
Vital signs include heart rate, blood pressure, and oral temperature
Measured: Screening, Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20 and Day 22
Change from baseline in clinical laboratory parameters
Laboratory parameters include haematology and, clinical chemistry tests
Measured: Screening, Day 11 (+/-2 days) and Day 22
Change from baseline in electrocardiogram (ECG) findings
Single 12-lead ECGs will be obtained using an ECG machine to monitor cardiac safety
Measured: Screening, Day 11 (+/-2 days) and Day 22 (+/-2 days)
Plasma trough concentrations of GSK2894512
Trough concentration is the minimum concentration of GSK2894512 observed after its administration and just prior to the administration of a subsequent dose
Measured: Day 11 (+/- 2 days) and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study start30 Oct 2013
- Primary completion2 Jul 2014
- Study completion2 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 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
- NCT01984775
- Sponsor's protocol ID
- 117191
- Status last verified
- Jun 2017
- First submitted
- 31 Oct 2013
- Last updated
- 16 Jun 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 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluator-Blinded Study to Evaluate the Cumulative Irritation Potential of Topically-Applied GSK2894512 Cream in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01984775
- Acronym / sponsor ID
- 117191
- Conditions
- Psoriasis
- Keywords
- safety, dermal, GSK2894512, Cumulative irritation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Stiefel, a GSK CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2013 (actual)
- Primary completion
- 2 Jul 2014 (actual)
- Study completion
- 2 Jul 2014 (actual)
- First posted
- 15 Nov 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.
This study is conducted to assess the potential of topically-applied GSK2894512 cream at 3 concentrations (0.5%, 1%, and 2%) to induce skin irritation at the site of application in healthy subjects. Results from this study will be considered when selecting the concentration(s) of GSK2894512 to evaluate in the Phase II and Phase III clinical safety and efficacy studies. Approximately 40 subjects will be enrolled in order to have at least 30 evaluable subjects complete the study. The total duration of subject participation may be up to 50 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GSK2894512 0.5% | Experimental | Drug: GSK2894512 creamEach subject will receive a topical application of GSK2894512 0.5% under semi-occlusive patch conditions once daily (OD) for 21 days. |
| GSK2894512 1% | Experimental | Drug: GSK2894512 creamEach subject will receive a topical application of GSK2894512 1% under semi- occlusive patch conditions OD for 21 days. |
| GSK2894512 2% | Experimental | Drug: GSK2894512 creamEach subject will receive a topical application of GSK2894512 2% under semi-occlusive patch conditions OD for 21 days. |
| Vehicle | Placebo comparator | Drug: Vehicle creamEach subject will receive a topical application of Vehicle cream under semi-occlusive patch conditions OD for 21 days. |
| Sodium lauryl sulfate 0.1% | Active comparator | Drug: Positive controlEach subject will receive a topical application of 0.2 milliliter (mL) of Sodium lauryl sulfate under semi-occlusive patch conditions OD for 21 days. This will serve as a positive control. |
| Petrolatum | Active comparator | Drug: Negative controlEach subject will receive a topical application of 0.2 mL of Petrolatum under semi-occlusive patch conditions OD for 21 days. This will serve as a negative control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 65 years, inclusive, at time of consent.
- In generally good overall health with healthy skin in the potential test sites on the back.
- Skin tone in the potential test sites on the back such that erythema and other dermal reactions can be easily visualized, i.e., 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). Determination of skin types is based on sunburn and tanning history in response to the first 30 to 45 minutes of sun exposure.
- A woman is eligible to participate if she is of non-childbearing potential, defined as a woman with functioning ovaries who has a documented bilateral tubal ligation/sterilization or hysterectomy, bilateral oopherectomy, or postmenopausal with at least 12 months of spontaneous amenorrhea.
Key exclusion criteria (11 listed)
- History of known or suspected intolerance to GSK2894512, any of the ingredients of the study products, adhesive tape/plaster, or the test chambers.
- Inability to evaluate the skin at and around the potential test sites on the back due to sunburns, unevenness in skin tone, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
- Clinically-relevant skin disease, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer, that may, in the opinion of the investigator, contraindicate participation or interfere with test site evaluations.
- Considered immunocompromised, or has a clinically-relevant history of or currently suffering from any disease or condition that, in the opinion of the investigator, might affect the evaluation of the study product or place the subject at undue risk.
- Used prohibited concomitant medications or products within the defined washout periods before the Day 1 visit. This includes investigational products, allergy injections, immunizations, corticosteroids, immunomodulators, anti-inflammatories, antihistamines, selective leukotriene receptor antagonists, mast cell stabilizers, and topical medications or products at and around the potential test sites.
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 |
|---|---|---|
| GSK2894512 creamGSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% [5 milligram (mg)/gram (g)], 1% [10 mg/g], and 2% [20 mg/g]). | Drug | GSK2894512 0.5%, GSK2894512 1%, GSK2894512 2% |
| Vehicle creamVehicle cream does not contain any active pharmaceutical ingredient. | Drug | Vehicle |
| Positive controlPositive control contains sodium lauryl sulfate solution 0.1% (1 mg/g). | Drug | Sodium lauryl sulfate 0.1% |
| Negative controlNegative control contains petrolatum. | Drug | Petrolatum |
Primary outcome
Mean cumulative irritation score
Time frame: 21 Days
It is the sum of dermal response irritation scores from Day 2 through Day 22 divided by the number of non-missing observations
Total cumulative irritation score
Time frame: 21 Days
It is the sum of dermal response irritation scores from Day 2 through Day 22
5 secondary outcomes
Incidence of adverse events (AEs) and treatment-related AEs
Time frame: Up to Day 22
Change from baseline in vital signs
Time frame: Screening, Day 1, Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18, Day 20 and Day 22
Change from baseline in clinical laboratory parameters
Time frame: Screening, Day 11 (+/-2 days) and Day 22
Change from baseline in electrocardiogram (ECG) findings
Time frame: Screening, Day 11 (+/-2 days) and Day 22 (+/-2 days)
Plasma trough concentrations of GSK2894512
Time frame: Day 11 (+/- 2 days) and Day 22
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 16 Jun 2017.
- Results for study 117191 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2894512 cream in people with Psoriasis, run by Stiefel, a GSK Company at 2 sites in 2 countries.
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 4 inclusion and 11 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 16 Jun 2017. 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 United States, 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 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?
Mean cumulative irritation score (time frame: 21 Days). The study lists 2 primary outcomes in all. 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 16 Jun 2017.