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

NCT ID: NCT01984775

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-30
• Study Completion Date: 2014-07-02

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GSK2894512 0.5%

Each subject will receive a topical application of GSK2894512 0.5% under semi-occlusive patch conditions once daily (OD) for 21 days.

Group Type: EXPERIMENTAL

GSK2894512 cream

Intervention Type: DRUG

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% \[20 mg/g\]).

GSK2894512 1%

Each subject will receive a topical application of GSK2894512 1% under semi- occlusive patch conditions OD for 21 days.

Group Type: EXPERIMENTAL

GSK2894512 cream

Intervention Type: DRUG

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% \[20 mg/g\]).

GSK2894512 2%

Each subject will receive a topical application of GSK2894512 2% under semi-occlusive patch conditions OD for 21 days.

Group Type: EXPERIMENTAL

GSK2894512 cream

Intervention Type: DRUG

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

Each subject will receive a topical application of Vehicle cream under semi-occlusive patch conditions OD for 21 days.

Group Type: PLACEBO_COMPARATOR

Vehicle cream

Intervention Type: DRUG

Vehicle cream does not contain any active pharmaceutical ingredient.

Sodium lauryl sulfate 0.1%

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.

Group Type: ACTIVE_COMPARATOR

Positive control

Intervention Type: DRUG

Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).

Petrolatum

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.

Group Type: ACTIVE_COMPARATOR

Negative control

Intervention Type: DRUG

Negative control contains petrolatum.

Interventions

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% \[20 mg/g\]).

Intervention Type: DRUG

Vehicle cream

Vehicle cream does not contain any active pharmaceutical ingredient.

Intervention Type: DRUG

Positive control

Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).

Intervention Type: DRUG

Negative control

Negative control contains petrolatum.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Hamburg, , Germany

Countries

United States; Germany

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Other Identifiers

117191

Identifier Type: -

Identifier Source: org_study_id