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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000244-24 | EudraCT Number |
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The aim of this proof of principle study is to evaluate efficacy and safety of the sequential application of two marketed products for the treatment of acne vulgaris, using the Split-Face model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical retinoid - Placebo | Placebo Comparator |
| |
| Topical retinoid-NSAID | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| marketed topical retinoid | Drug | once daily application, 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | Percentage change in inflammatory lesions count from baseline to the end of treatment | Baseline to End of treatment (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inflammatory Lesions Count | Percentage change in non-inflammatory lesions count from baseline to the end of treatment | Baseline to End of treatment (4 weeks) |
| Total Lesions Count | Percentage change in total lesions count from baseline to the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Mrs Queille-Roussel, MD | Centre de Pharmacologie Clinique Applique a la Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie | Nice | 06202 | France |
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Start date: 21-NOV-2011 (FSFV - first subject first visit) Completion date: 26-APR-2012 (LSLV - last subject last visit)
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Retinoid - Placebo, Topical Retinoid - NSAID | Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris. The randomised subjects received the following products:
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Retinoid - Placebo, Topical Retinoid - NSAID | marketed topical retinoid : once daily application, 4 weeks vehicle gel : once daily application, 4 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Inflammatory Lesions From Baseline to End of Treatment | Percentage change in inflammatory lesions count from baseline to the end of treatment | Posted | Median | Standard Deviation | percentage of change | Baseline to End of treatment (4 weeks) |
|
Adverse events were collected from study start untill 43 (±2)days after the last on-treatment visit if an AE (serious or non-serious) classified as possible or probably related to the study treatment was ongoing at the last on-treatment visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Retinoid - Placebo, Topical Retinoid - NSAID |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| marketed topical NSAID |
| Drug |
once daily application, 4 weeks |
|
| vehicle gel | Drug | once daily application, 4 weeks |
|
| marketed topical retinoid | Drug | once daily application, 4 weeks |
|
| Baseline to End of treatment (4 weeks) |
| Percentage Change in Total Lesions Count | Percentage change in total leasions count from baseline to day 8 | Baseline to Day 8 |
| Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 15 | Baseline to Day 15 |
| Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 22 | Baseline to Day 22 |
| Investigator Global Assessment (IGA) of Disease Severity | The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. "Success" is defined as improvement of two grades from the baseline assessment. | Baseline to End of treatment (4 weeks) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Non-inflammatory Lesions Count | Percentage change in non-inflammatory lesions count from baseline to the end of treatment | Posted | Mean | Standard Deviation | percentage of change | Baseline to End of treatment (4 weeks) |
|
|
|
| Secondary | Total Lesions Count | Percentage change in total lesions count from baseline to the end of treatment | Posted | Mean | Standard Deviation | percentage of change | Baseline to End of treatment (4 weeks) |
|
|
|
| Secondary | Percentage Change in Total Lesions Count | Percentage change in total leasions count from baseline to day 8 | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 8 |
|
|
|
| Secondary | Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 15 | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 15 |
|
|
|
| Secondary | Percentage Change in Total Lesions Count | Percentage change in total lesions count from baseline to day 22 | Posted | Mean | Standard Deviation | percentage of change | Baseline to Day 22 |
|
|
|
| Secondary | Investigator Global Assessment (IGA) of Disease Severity | The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). The outcome was the proportion of "success" (improvement of two grades of the IGA) from baseline to the end of treatment. "Success" is defined as improvement of two grades from the baseline assessment. | Posted | Number | participants | Baseline to End of treatment (4 weeks) |
|
|
|
| 0 |
| 40 |
| 40 |
| 40 |
| Nasopharyngitis | Infections and infestations | MedDRA 6.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
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Prior to submitting or presenting a manuscript, the investigator shall provide to LEO Pharma a copy of all such manuscripts, and LEO Pharma shall have rights to review and comment. Upon the request of LEO Pharma the investigator shall remove any confidential information prior to submitting or presenting the manuscripts. The investigator shall, upon the request of LEO Pharma, delay publication or presentation to allow LEO Pharma to protect its inventions and other intellectual property rights.