Randomised, Double-blind, Placebo-controlled Study of Topical Clobetasone Butyrate 0.05% Cream in Subjects With Eczema for Two Weeks to Evaluate the Efficacy and Safety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01567995
First received: March 29, 2012
Last updated: December 17, 2012
Last verified: March 2012
  Purpose

This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base) -controlled, parallel-group study in subjects with moderate to severe eczema (defined by investigators global assessment (IGA) score greater than or equal to 3).

Subjects were screened within 3 days prior to randomization. At the screen visit, subjects gave informed consent and were then assessed for health status and eligibility for inclusion in the study. At the baseline visit, subject eligibility was assessed for randomization (Day 0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the sites in day 7 post-baseline visit for assessment of their disease status and eligibility to continue on the study. During the final visit, 14 days after the baseline, subjects returned to the study sites for assessment of their disease status before completing the study. In addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed through the whole trial.


Condition Intervention Phase
Dermatitis, Eczematous
Drug: Clobetasone Butyrate 0.05% Cream
Drug: Vehicle (base cream)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Study of Topical Clobetasone Butyrate Cream in Patients With Eczema for Two Weeks to Evaluate the Efficacy and Safety

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline Eczema Area and Severity Index (EASI) [ Time Frame: baseline to 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline Investigator Global Assessment (IGA) of disease severity in eczema [ Time Frame: baseline up to 14 days ] [ Designated as safety issue: No ]
  • Change from baseline in pruritus assessed by a visual analogue scale (VAS) [ Time Frame: baseline up to 14 days ] [ Designated as safety issue: No ]
  • Subjects global assessment of treatments [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clobetasone Butyrate 0.05% Cream
Clobetasone Butyrate 0.05% Cream
Drug: Clobetasone Butyrate 0.05% Cream
Clobetasone Butyrate 0.05% Cream
Vehicle (base cream)
Vehicle (base cream)
Drug: Vehicle (base cream)
Vehicle (base cream)

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of eczema, fulfil the 3 follow items: 1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration, 2) unknown reason, recurrent attacks; 3) itching in diseased skin
  • Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
  • Subject must present with moderate and above eczema as defined by a score greater than or equal to 3 using the investigators global assessment (IGA) of eczema severity.

Exclusion Criteria:

  • The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results 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 eczema restricted to the face, the feet or the hands only.
  • The subject is indicated any anti-infectives drug for a current complication of overt bacterial, fungal and viral infection
  • History of recent (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
  • The subject has been exposed to below therapy within the set timeframe: Topical agents administered in the diseased skin, including emollient - 1 week; Systemic administration of anti-histamine agents - 2 week; Systemic administration of corticosteroid -4 week; Systemic administration of immunosuppressive drugs - 4 week; UV therapy -4 week
  • Foreseeable intensive ultraviolet (UV) exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
  • History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.
  • History of allergy to components of test medications to be used in the study.
  • History of anaphylaxis (a sudden, potentially life-threatening systemic allergic reaction) to food, medications, insect venom, or latex.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567995

Locations
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210042
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
China
GSK Investigational Site
Beijing, China, 100044
GSK Investigational Site
Beijing, China, 100730
GSK Investigational Site
Beijing, China, 100034
GSK Investigational Site
Shanghai, China, 200040
GSK Investigational Site
Tianjin, China, 300052
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01567995     History of Changes
Other Study ID Numbers: 111187
Study First Received: March 29, 2012
Last Updated: December 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
eczematous
dermatitis

Additional relevant MeSH terms:
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Clobetasone butyrate
Clobetasol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014