A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects

Psoriasis Clinical Trial

Official title:

An Evaluator-Blinded Study to Evaluate the Cumulative Irritation Potential of Topically-Applied GSK2894512 Cream in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984775
• Other study ID #: 117191
• Status: Completed
• Phase: Phase 1
• First received: October 31, 2013
• Last updated: June 14, 2017
• Start date: October 30, 2013
• Est. completion date: July 2, 2014

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2, 2014
• Est. primary completion date: July 2, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• GSK2894512 cream
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 cream
Vehicle cream does not contain any active pharmaceutical ingredient.
• Positive control
Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).
• Negative control
Negative control contains petrolatum.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hamburg
United States	GSK Investigational Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Stiefel, a GSK Company

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	21 Days
Primary	Total cumulative irritation score	It is the sum of dermal response irritation scores from Day 2 through Day 22	21 Days
Secondary	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	Up to Day 22
Secondary	Change from baseline in vital signs	Vital signs include heart rate, blood pressure, and oral temperature	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
Secondary	Change from baseline in clinical laboratory parameters	Laboratory parameters include haematology and, clinical chemistry tests	Screening, Day 11 (+/-2 days) and Day 22
Secondary	Change from baseline in electrocardiogram (ECG) findings	Single 12-lead ECGs will be obtained using an ECG machine to monitor cardiac safety	Screening, Day 11 (+/-2 days) and Day 22 (+/-2 days)
Secondary	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	Day 11 (+/- 2 days) and Day 22

External Links

•   Results for study 117191 can be found on the GSK Clinical Study Register.