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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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatitis, Eczematous

Intervention: Clobetasone Butyrate 0.05% Cream (Drug); Vehicle (base cream) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline Eczema Area and Severity Index (EASI)

Secondary outcome:

Change from baseline Investigator Global Assessment (IGA) of disease severity in eczema

Change from baseline in pruritus assessed by a visual analogue scale (VAS)

Subjects global assessment of treatments

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Beijing 100034, China

GSK Investigational Site, Beijing 100044, China

GSK Investigational Site, Beijing 100730, China

GSK Investigational Site, Shanghai 200040, China

GSK Investigational Site, Tianjin 300052, China

GSK Investigational Site, Nanjing, Jiangsu 210029, China

GSK Investigational Site, Nanjing, Jiangsu 210042, China

Additional Information

Starting date: February 2008
Last updated: December 17, 2012

Page last updated: August 23, 2015

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