Clinical trial NCT01567995: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eczema
Keywords: eczematous
dermatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in Eczema Area and Severity Index (EASI) score at Day 7
timeFrame: Baseline, Day 7
measure: Change from baseline in Eczema Area and Severity Index (EASI) score at Day 14
timeFrame: Baseline, Day 14
measure: Reduction Percentage of Eczema Area and Severity Index (EASI) score after 7 day of treatment
timeFrame: up to Day 7
measure: Reduction Percentage of Eczema Area and Severity Index (EASI) score after 14 days of treatment
timeFrame: up to Day 14
Secondary outcomes:
measure: Change from baseline in Investigators Global Assessment (IGA) graded score at Day 7 and Day 14
timeFrame: Baseline, Day 7 and Day 14
measure: Changes from baseline in Visual Analog Scale (VAS) at Day 7 and Day 14
timeFrame: Baseline, Day 7 and Day 14
measure: Number of participants with participants-based assessment score of disease control at Day 7 and Day 14
timeFrame: Day 7 and Day 14
Other outcomes:
Locations:
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: