Last updated: 11/07/2018 11:54:31

Skin Irritation Study of GSK2894512 Cream

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GSK study ID
200920
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Clinicaltrials.gov ID
NCT02637206
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Skin Irritation Study of GSK2894512 Cream-An Evaluator-Blinded Study to Evaluate the Skin Irritation of GSK2894512 Cream and Placebo following Single Application by Simple-Patch Test and Photo-Patch Test, and Repeat Application under non-occlusive condition in Healthy Japanese Subjects
Trial description: GSK2894512 is a novel anti-inflammatory agent that is currently under development for the topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese volunteers. Part 2 of this study will assess skin irritation following repeat application at 0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6 healthy Japanese volunteers. The study will have Screening visit which will occur within 30 days from the Day 1 visit of each part. Eligible subjects will be able to participate either of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and repeat application in Japanese subjects. Results from this study will enable further clinical investigation in the Japanese population.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Part 1-Positive rate of skin irritability as assessed by simple-patch test following single application of GSK2894512 cream

Timeframe: Up to Day 4

Part 1-Positive rate of photo-urticaria reaction as assessed by photo patch test following single application of GSK2894512 cream

Timeframe: Day 2

Part 1-Positive rate of photo-toxicity as assessed by photo patch test following single application of GSK2894512 cream

Timeframe: Up to Day 4

Part 2- Positive rate of Skin irritability following repeat application of GSK2894512 cream

Timeframe: Day 1 to Day 8

Part 2- Skin observation (subjective symptom)

Timeframe: Day 1 to Day 7

Secondary outcomes:

Part 1: Number of subject with adverse events

Timeframe: From Day 1 to Day 8

Part 2: Number of subject with adverse events

Timeframe: From Day 1 to Day 15

Part 1:Safety as assessed by systolic and diastolic blood pressure measurements

Timeframe: Day -1 to Day 8

Part 2: Safety as assessed by systolic and diastolic blood pressure measurements

Timeframe: Day -1 to Day 15

Part 1:Safety as assessed by pulse rate measurement

Timeframe: Day -1 to Day 8

Part 2: Safety as assessed by pulse rate measurement

Timeframe: Day -1 to Day 15

Part 1:Safety as assessed by12-lead electrocardiogram (ECG)

Timeframe: Day -1 to Day 8

Part 2: Safety as assessed by12-lead ECG

Timeframe: Day -1 to Day 15

Part 1:Safety as assessed by clinical laboratory test

Timeframe: Day -1, 4 and 8

Part 2: Safety as assessed by clinical laboratory test

Timeframe: Day -1, 4, 8 and 15

Part 2: Plasma concentration of GSK2894512

Timeframe: Day 1 and Day 7 (pre-dose, 2, 4 hours post-AM application); Day 3 and Day 5 (pre-dose of AM application)

Interventions:
  • Drug: GSK2894512 Cream
  • Drug: Vehicle Cream
  • Drug: Empty Patch
    • Enrollment:
    26
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hirofumi Ogura, Shuji Miki, Akira Endo, Harue Igarashi, Yotaro Numachi. Evaluation of Skin Safety of GSK2894512 Cream in Japanese Healthy Volunteers. J Clin Therapeut Med. 2017;33(3):229-237.
    Medical condition
    Dermatitis, Atopic
    Product
    tapinarof
    Collaborators
    Not applicable
    Study date(s)
    October 2015 to December 2015
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 64 years
    Accepts healthy volunteers
    Yes
    • Japanese males and females aged between 20 and 64 years of age inclusive, at the time of signing the informed consent.
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. 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 GlaxoSmithKline (GSK) Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • History of known or suspected intolerance to any of the ingredients of the study products, adhesive tape/plaster, or the test patches.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Japanese males and females aged between 20 and 64 years of age inclusive, at the time of signing the informed consent.
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. 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 GlaxoSmithKline (GSK) Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    • Healthy skin in the potential test site on the back such that erythema and other dermal reactions can be easily visualized.
    • Body Mass Index within the range 18.5 – 24.9 kilogram per square meter (kg/m^2,inclusive) and less than 25.0 kg/m^2.
    • 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 defined as 12 months of spontaneous amenorrhea with simultaneous follicle stimulating hormone (FSH) > 40 milli-international units per milliliter and estradiol < 40 picograms per milliliter (<147 picomole per liter).
    • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
    • Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <= 1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    • Based on single QTc values: QT interval corrected for heart rate according to Fridericia’s formula (QTcF) < 450 milliseconds; QTcF < 480 msec in subjects with Bundle Branch Block.
    Exclusion criteria:
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • History of known or suspected intolerance to any of the ingredients of the study products, adhesive tape/plaster, or the test patches.
    • Subjects with inherent sensitivity to sun or history of photosensitivity.
    • 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.
    • A positive pre-study syphilis, Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antigen antibody or Human T-cell Lymphotropic Virus-1 result of screening.
    • A positive pre-study drug screen.
    • The subject has donated a unit of blood ">400 milliliter (mL)" within the previous 4 months or ">200 mL" within the previous 1 month prior to the first dosing day.
    • The subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months prior to the first dosing day.
    • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    • The subject planned to concurrently participate in another clinical study or post-marketing study.
    • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 14 days prior to the first application of study medication.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    • Subject is mentally or legally incapacitated.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Fukuoka, Japan, 812-0025
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
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    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2015-02-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
    Results for study 200920 can be found on the GSK Clinical Study Register.
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