A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo

NCT01299610 | Completed Phase 2 Results

• 1 other identifier: 113434
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatitis, Atopic

Keywords

Atopic Dermatitis; GW870086X; TIS; IGA

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22

  Three target lesions were selected and each of the 3 target lesions were assessed separately using the TIS for erythema, oedema/papulation, and excoriation using a score of 0 - 3 as 0 = absent, 1 = mild, 2 = moderate, 3 = severe. Each participant had at least 3 index lesions (=\> 1square centimeter in size) with a sum score of =\>4 and =\< 6 for erythema, oedema/populations and excoriations using the TIS rating scale at screening. The index lesions represented common lesions i.e. not the most or least severe lesions. The total TIS score for a lesion was calculated as the sum of each of the component scores i.e. ranging from 0 (no symptoms) to 9 (severe symptoms). The values of Day 1 assessments were considered as Baseline values. The change from Baseline was calculated by subtracting the Baseline TIS score from Day 22 TIS score.

  Baseline (Day 1) and Day 22

Secondary Outcomes (10)

• Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14

  Days 2, 3, 7, and 14

• Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22

  Days 2, 3, 7, 14 and 22

• Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Upto Day 21

• Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI)

  Up to Day 21

• Number of Participants With Abnormal Electrocardiogram (ECG) of PCI

  Up to Day 21

Study Arms (3)

GW870086 2.0% &amp; 0.2%

EXPERIMENTAL

GW870086 2.0%, GW870086 0.2% \&amp; Placebo each applied to a separate specific lesion for 21±2 days.

Drug: GW870086 2.0%; Drug: GW870086 0.2%; Drug: Placebo

GW870086 2.0% & FP 0.05%

EXPERIMENTAL

GW870086 2.0%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days.

Drug: GW870086 2.0%; Drug: FP 0.05%; Drug: Placebo

GW870086 0.2% & FP 0.05%

EXPERIMENTAL

GW870086 0.2%, FP 0.05% \&amp; Placebo each applied to a separate specific lesion for 21±2 days.

Drug: GW870086 0.2%; Drug: FP 0.05%; Drug: Placebo

Interventions

GW870086 2.0% DRUG

White to slightly colored opaque cream

GW870086 2.0% & FP 0.05%; GW870086 2.0% &amp; 0.2%

GW870086 0.2% DRUG

White to slightly colored opaque cream

GW870086 0.2% & FP 0.05%; GW870086 2.0% &amp; 0.2%

FP 0.05% DRUG

White cream

GW870086 0.2% & FP 0.05%; GW870086 2.0% & FP 0.05%

Placebo DRUG

White to slightly colored opaque cream

GW870086 0.2% & FP 0.05%; GW870086 2.0% & FP 0.05%; GW870086 2.0% &amp; 0.2%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
• AST and ALT \< 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 10117, Germany

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 14, 2011
• Last Updated: November 17, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)