EczemaPhase 3NCT01567995
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
A Phase 3 study testing Clobetasone Butyrate 0.05% Cream in people with Eczema, run by GlaxoSmithKline at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Eczema
- What is being tested?
- Clobetasone Butyrate 0.05% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesChina
- Study dates
- 28 Feb 2008to 10 Feb 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
GSK Investigational Site
Beijing, 100034
GSK Investigational Site
Beijing, 100044
GSK Investigational Site
Beijing, 100730
GSK Investigational Site
Nanjing, Jiangsu, 210029
GSK Investigational Site
Nanjing, Jiangsu, 210042
GSK Investigational Site
Shanghai, 200040
GSK Investigational Site
Tianjin, 300052
About this study
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
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.
- Conditions
- Eczema
- Being tested
- Clobetasone Butyrate 0.05% Cream, Vehicle (base cream)
- Keywords
- eczematous, dermatitis
- Medical subject headings
- Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasone Butyrate 0.05% CreamDrug
Clobetasone Butyrate 0.05% Cream
Vehicle (base cream)Drug
Vehicle (base cream)
| Study group | Role | What they receive |
|---|---|---|
| Clobetasone Butyrate 0.05% Cream | Experimental | Clobetasone Butyrate 0.05% Cream Receives: Drug: Clobetasone Butyrate 0.05% Cream |
| Vehicle (base cream) | Other | Vehicle (base cream) Receives: Drug: Vehicle (base cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 7
Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas using EASI: head/neck, upper limbs, trunk, and lower limbs. Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.
Measured: Baseline, Day 7
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 14
Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas using EASI: head/neck, upper limbs, trunk, and lower limbs. Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.
Measured: Baseline, Day 14
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 7 day of treatment
Investigator assessed surface \& severity of erythema, induration/papulation, excoriation \& lichenification in four body areas using EASI: head/neck, upper extremities, trunk \& lower extremities. Investigators assigned a severity score (0-3) for each area (none=0, mild=1, moderate=2, severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. Weighting factor was 0.1 for head/neck, 0.2 for upper extremities, 0.3 for trunk \& 0.4 for lower extremities. Total body score for each body region was obtained by multiplying sum of severity scores by area score, then multiplying result by constant weighted value assigned to that body region. Sum of these scores gave EASI total, ranging from 0 to 72. Reduction percentage of score was calculated as: (sum of score after day 7 minus sum of score at baseline) *100/sum of score after day 7. Lesser negative reduction percentage lesser severity of disease, more effectiveness of treatment.
Measured: up to Day 7
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 14 days of treatment
Investigator assessed surface \& severity of erythema, induration/papulation, excoriation \& lichenification in four body areas using EASI: head/neck, upper extremities, trunk \& lower extremities. Investigators assigned a severity score (0-3) for each area (none=0, mild=1, moderate=2, severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. Weighting factor was 0.1 for head/neck, 0.2 for upper extremities, 0.3 for trunk \& 0.4 for lower extremities. Total body score for each body region was obtained by multiplying sum of severity scores by area score, then multiplying result by constant weighted value assigned to that body region. Sum of these scores gave EASI total, ranging from 0 to 72. Reduction percentage of score was calculated as: (sum of score after day 14 minus sum of score at baseline) *100/sum of score after day 14. Lesser negative reduction percentage lesser severity of disease, more effectiveness of treatment.
Measured: up to Day 14
Secondary outcomes (3)
Change from baseline in Investigators Global Assessment (IGA) graded score at Day 7 and Day 14
The IGA was used to determine disease severity in a given time and describe severity of eczema using scale of 0 to 6 as follows: 0 Clear:=No inflammatory signs of eczema; 1 Almost clear=Just perceptible erythema and just perceptible papulation/infiltration; 2 Mild:=Mild erythema and mild papulation/infiltration; 3 Moderate:=Moderate erythema, and moderate papulation/infiltration; 4 Severe= Severe erythema, and severe papulation/infiltration; 5 Very Severe=Very severe erythema, and very severe papulation/infiltration with oozing/crusting. Lesser score indicate lesser disease severity.
Measured: Baseline, Day 7 and Day 14
Changes from baseline in Visual Analog Scale (VAS) at Day 7 and Day 14
Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=maximum itch) at Baseline, Day 7 and Day 14. Higher pruritus/itch VAS score indicating more severe pruritus/itching.
Measured: Baseline, Day 7 and Day 14
Number of participants with participants-based assessment score of disease control at Day 7 and Day 14
The participant's assessment score is a semi-quantitative score intended to reflect the participants own evaluation of disease control. It consisted of a four-point scale ranging from complete disease control (0) to uncontrolled disease (3): 0 - Complete disease control; 1 - Good disease control; 2 - Limited disease control; 3 - Uncontrolled disease. Lesser score indicate better disease control.
Measured: Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study start28 Feb 2008
- Primary completion1 Jan 2009
- Study completion10 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567995
- Sponsor's protocol ID
- 111187
- Status last verified
- Nov 2017
- First submitted
- 29 Mar 2012
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01567995
- Acronym / sponsor ID
- 111187
- Conditions
- Eczema
- Keywords
- eczematous, dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2008 (actual)
- Primary completion
- 1 Jan 2009 (actual)
- Study completion
- 10 Feb 2009 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clobetasone Butyrate 0.05% Cream | Experimental | Drug: Clobetasone Butyrate 0.05% CreamClobetasone Butyrate 0.05% Cream |
| Vehicle (base cream) | Other | Drug: Vehicle (base cream)Vehicle (base cream) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clobetasone Butyrate 0.05% CreamClobetasone Butyrate 0.05% Cream | Drug | Clobetasone Butyrate 0.05% Cream |
| Vehicle (base cream)Vehicle (base cream) | Drug | Vehicle (base cream) |
Primary outcome
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 7
Time frame: Baseline, Day 7
Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas using EASI: head/neck, upper limbs, trunk, and lower limbs. Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 14
Time frame: Baseline, Day 14
Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas using EASI: head/neck, upper limbs, trunk, and lower limbs. Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 7 day of treatment
Time frame: up to Day 7
Investigator assessed surface \& severity of erythema, induration/papulation, excoriation \& lichenification in four body areas using EASI: head/neck, upper extremities, trunk \& lower extremities. Investigators assigned a severity score (0-3) for each area (none=0, mild=1, moderate=2, severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. Weighting factor was 0.1 for head/neck, 0.2 for upper extremities, 0.3 for trunk \& 0.4 for lower extremities. Total body score for each body region was obtained by multiplying sum of severity scores by area score, then multiplying result by constant weighted value assigned to that body region. Sum of these scores gave EASI total, ranging from 0 to 72. Reduction percentage of score was calculated as: (sum of score after day 7 minus sum of score at baseline) *100/sum of score after day 7. Lesser negative reduction percentage lesser severity of disease, more effectiveness of treatment.
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 14 days of treatment
Time frame: up to Day 14
Investigator assessed surface \& severity of erythema, induration/papulation, excoriation \& lichenification in four body areas using EASI: head/neck, upper extremities, trunk \& lower extremities. Investigators assigned a severity score (0-3) for each area (none=0, mild=1, moderate=2, severe=3). Investigators also assigned an area score from 0 (no eruption) to 6 (>90-100% eruption) for each area. Weighting factor was 0.1 for head/neck, 0.2 for upper extremities, 0.3 for trunk \& 0.4 for lower extremities. Total body score for each body region was obtained by multiplying sum of severity scores by area score, then multiplying result by constant weighted value assigned to that body region. Sum of these scores gave EASI total, ranging from 0 to 72. Reduction percentage of score was calculated as: (sum of score after day 14 minus sum of score at baseline) *100/sum of score after day 14. Lesser negative reduction percentage lesser severity of disease, more effectiveness of treatment.
3 secondary outcomes
Change from baseline in Investigators Global Assessment (IGA) graded score at Day 7 and Day 14
Time frame: Baseline, Day 7 and Day 14
Changes from baseline in Visual Analog Scale (VAS) at Day 7 and Day 14
Time frame: Baseline, Day 7 and Day 14
Number of participants with participants-based assessment score of disease control at Day 7 and Day 14
Time frame: Day 7 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clobetasone Butyrate 0.05% Cream in people with Eczema, run by GlaxoSmithKline at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 7 (time frame: Baseline, Day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.