Phase 2
N=25
A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo
Dermatitis, Atopic
Bottom Line
View on ClinicalTrials.gov: NCT01299610 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22 — -1.99; -2.49; -1.61; -3.11 Score on scale — p=0.480
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GW870086 2.0% (Drug); GW870086 0.2% (Drug); FP 0.05% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22 |
-1.99; -2.49; -1.61; -3.11 | 0.480 |
| SECONDARY Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14 |
-0.37; -0.53; -0.45; -0.62; -0.91; -0.80 | 0.581 |
| SECONDARY Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22 |
0; 0; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 2; 5; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI) |
1; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) of PCI |
1; 1; 1 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI |
0; 0; 0 | — |
| SECONDARY Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X |
— | — |
| SECONDARY Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086 |
— | — |
| SECONDARY Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086 |
— | — |
| SECONDARY Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis |
— | — |
Summary
This study is a randomised, double-blind, placebo-controlled study to assess the efficacy of GW870086X cream formulation in subjects with moderate to severe atopic dermatitis. Subjects will be assigned to take 3 out of the 4 possible treatments for 21 ±2 days: GW870086X 0.2% cream, GW870086X 2% cream, FP 0.05% cream (as a positive control) and placebo cream. All subjects will be randomised to receive placebo cream. Three index lesions located on the arms and/or legs (one on each) will be identified per subject and each treatment will be applied to the same lesion.
Eligibility Criteria
Inclusion Criteria
- Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
- Male or female between 18 and 65 years of age inclusive.
- 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. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Subjects must have body surface area (BSA) disease involvement of >5% as assessed by the rule of nines method.
- Patients must be willing to refrain from current active therapy for at least 10 days prior to dosing,
- Capable of giving written informed consent.
- Single QTc, QTcB 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria
- The subject presents with any systemic disorder, active skin disease or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
- The subject has atopic dermatitis restricted to the face, the feet or the hands only.
- The subject has a current complication of atopic dermatitis for which treatment with anti-infectives are indicated.
- History of recent (< 6 months) active or presence of current superficial skin infections of viral aetiology
- The subject has been diagnosed as having contact dermatitis in area of target lesions, seborrheic dermatitis and/or occupational eczema at predilection sites of atopic dermatitis.
- The subject has had topical or transdermal treatments on or near the intended site of application within 14 days prior to first application of study medication.
- The subject has had systemic treatment for atopic dermatitis within 28 days of the first dose of study medication.
- Foreseeable intensive UV exposure during the study. Subjects must not be exposed to direct sunlight or skin tanning devices for the duration of the study.
- The subject has used topical treatment with tar or any corticosteroid within 14 days of the first dose of study medication except topical 1% hydrocortisone which may be used twice daily in patients with severe disease who require step-down therapy during the wash-out period until 3 days prior to study start, after which the hydrocortisone must be discontinued.
- The subject has used topical treatment with buproprion within 14 days of the first dose of study medication.
- History of cutaneous photodisorder.
- History of allergy to steroids or components of test medications.
- History or presence of skin (other than atopic dermatitis), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Subjects with a history of diaphoresis/excessive sweating not restricted to palms or face.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- 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.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a poten
Data sourced from ClinicalTrials.gov (NCT01299610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.