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The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.
Psoriasis was a chronic disease that was affecting skin, the scalp and joints. Scalp psoriasis was very common and was having an important impact on people's life.
Primary objective of scalp psoriasis treatments was to gain initial and rapid control of the disease process with a minimum of side-effects and improve patient quality of life.
Still, one of the unmet needs of scalp psoriasis therapies was the maintenance of a long-term remission. For corticosteroids in particular, one of the drawbacks was the disease recurrences after cessation of the treatment.
Therefore, the establishment of a modified corticosteroid dosing regimen that would allow remission with minimal side-effects was suitable.
The purpose of this study was to assess how long a patient successfully maintained in a good condition after use of Clobex® shampoo only twice a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial Phase:- Clobex® Shampoo | Experimental | In initial open-label phase, participants were applied Clobex® shampoo (Clobetasol Propionate) 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams [50 Milliliter]). |
|
| Maintenance Phase: Clobex® Shampoo | Experimental | In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] less than or equal to [<=] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 % weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams [50 milliliter]). In case of relapse (that is [i.e.], GSS greater than [>] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
|
| Maintenance Phase: Clobex® Vehicle Shampoo | Placebo Comparator | In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] <= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse (i.e., GSS [greater than] > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 % (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobex® Shampoo | Drug | Clobex® Shampoo 0.05 % (W/W) topically to scalp for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance Phase: Time to First Relapse | Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. | Baseline up to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Phase: Percentage of Participants With Global Severity Scores | Global severity score was evaluated on a scale of 0-4 and it was categorized as; Clear (score 0); no clinical signs or symptoms detected (hyperpigmentation or residual red coloration might be present), very mild (score 1); only very slight signs or symptoms detected (e.g., very fine scaling or slight erythema), mild (score 2); slight signs or symptoms detected (e.g., mild erythema and scaling, eventually associated to some barely detectable plaque elevation), moderate (score 3); moderate or clearly detectable signs or symptoms (e.g., definite redness with obvious scaling on a plaque that was elevated above skin level), severe (score 4); severe signs or symptoms detected (e.g., intense redness, profuse shedding, definite plaque thickness was most often present) where 0 indicates best and 4 indicates worst. Percentage of participants with GSS was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who needed systemic treatment for their body psoriasis
Subjects with a washout period for topical treatment(s) on the scalp less than:
Subjects with a washout period for systemic treatment(s) less than:
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| Name | Affiliation | Role |
|---|---|---|
| Poulin, MD | Centre de Recherche Dermatologique du Quebec Métropolitain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| centre de Recherche Dermatologique du Québec | Québec | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 288 participants were enrolled in initial phase of the study, of which 225 participants were eligible to enter maintenance phase after completion of initial phase. Out of 225 eligible participants, only 217 participants (as 8 participants withdrew consent) were randomized and received treatment in the maintenance phase either in Clobetasol Propionate Shampoo group or Vehicle group.
The study was conducted at 12 sites in Canada from 29 September 2006 (first participant first visit) to 20 August 2007 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Phase:- Clobex® Shampoo | In initial open-label phase, participants were applied Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams [50 Milliliter]). |
| FG001 | Maintenance Phase: Clobex® Shampoo | In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] less than or equal to [<=] 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05 percent (%) weight by weight (W/W) twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams [50 milliliter]). In case of relapse (that is [i.e.], GSS greater than [>] 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05%. After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
| FG002 | Maintenance Phase:Clobex® Vehicle Shampoo | In maintenance double-blind phase, participants presented with a good efficacy (Global severity score [GSS] <= 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose were not exceeded beyond 50 grams [50 milliliter]). In case of relapse (that is [i.e.], GSS [greater than] > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05 percent (%) weight by weight (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Phase (up to 4 Weeks) |
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| |||||||||||||||||||||
| Maintenance Phase (up to 6 Months) |
|
ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number). As per planned analysis, baseline data for all participants were collected at initial phase only.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | In initial open-label phase, participants were applied Clobetasol Propionate shampoo 0.05% topically to the scalp once daily (twice a week) for 4 weeks (wherein weekly dose was not more than 50 grams [50 milliliter]). In maintenance double-blind phase, participants presented with a good efficacy (GSS <= 2) in initial phase were randomized to apply Clobetasol Propionate Shampoo 0.05% (W/W) or Clobex® Vehicle Shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse (i.e., GSS > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05%. After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maintenance Phase: Time to First Relapse | Time to first relapse was defined as the duration between baseline of maintenance phase and the visit where the relapse occurred. The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. | ITT Population included the entire population who were enrolled and randomized (i.e., assigned a kit number). | Posted | Mean | Standard Error | days | Baseline up to 24 Weeks |
|
From baseline up to Week 28
Analysis was performed on safety population that included in the study. Safety population was defined as intent-to-treat population (entire population enrolled and randomized i.e., assigned a kit number), after exclusion of participants who never applied treatment with certainty based on monitoring report.
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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 | Initial Phase:- Clobex® Shampoo | In initial open-label phase, participants were applied Clobetasol Propionate 0.05% (W/W) shampoo topically to the scalp once daily (twice a week) for 4 weeks (weekly dose was not more than 50 grams [50 Milliliter]). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (8.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Clobex® Vehicle Shampoo | Drug | Clobex® Vehicle Shampoo 0.05 % (W/W) topically to scalp up to 6 months. |
|
| Clobex® Shampoo | Drug | Clobex® Shampoo 0.05% (W/W) topically to scalp up to 6 months. |
|
|
| Baseline, Weeks 2 and 4 LOCF |
| Initial Phase: Percentage of Participants With Pruritus Scores | Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching], not really bothersome), 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with pruritus score was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). | Baseline, Weeks 2 and 4 LOCF |
| Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores | Individual sign scores of erythema (abnormal redness of skin), scaling (scales attached to the scalp), plaque thickening (a thickening or elevation of a circumscribed lesion or plaque) were evaluated on a scale of 0-4; 0= none , 1= mild , 2=moderate , 3= severe, 4= very severe, where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling, and plaque thickening) scores were reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). | Baseline, Weeks 2 and 4 LOCF |
| Maintenance Phase: Percentage of Participants Who Had First Relapse | The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported. | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse | Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching, not really bothersome], 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with scalp psoriasis pruritus score at first relapse was reported. | Baseline up to Week 24 |
| Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse | The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Individual sign scores of erythema were evaluated on a scale of 0-4 (0= none, 1= mild, 2=moderate, 3= severe, 4= very severe), where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling and plaque thickening) scores were reported. There were no participants in scaling category with 0 score. | Baseline up to Week 24 |
| Maintenance Phase: Percentage of Participants With Number of Relapses Experienced | Number of relapses of participants were categorized as 0; zero relapse, 1; one relapse, 2; two relapse, 3; three relapse, 4; two consecutive relapses. Percentage of participants with total number of relapses experienced during maintenance period was reported. | Baseline up to Week 28 |
| Lost to Follow-up |
|
| Other |
|
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Maintenance Phase: Clobex® Vehicle Shampoo | In maintenance double-blind phase, participants presented with a good efficacy (GSS <=2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse (i.e., GSS > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate Shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). |
|
|
| Secondary | Initial Phase: Percentage of Participants With Global Severity Scores | Global severity score was evaluated on a scale of 0-4 and it was categorized as; Clear (score 0); no clinical signs or symptoms detected (hyperpigmentation or residual red coloration might be present), very mild (score 1); only very slight signs or symptoms detected (e.g., very fine scaling or slight erythema), mild (score 2); slight signs or symptoms detected (e.g., mild erythema and scaling, eventually associated to some barely detectable plaque elevation), moderate (score 3); moderate or clearly detectable signs or symptoms (e.g., definite redness with obvious scaling on a plaque that was elevated above skin level), severe (score 4); severe signs or symptoms detected (e.g., intense redness, profuse shedding, definite plaque thickness was most often present) where 0 indicates best and 4 indicates worst. Percentage of participants with GSS was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). | ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number). | Posted | Number | percentage of participants | Baseline, Weeks 2 and 4 LOCF |
|
|
|
| Secondary | Initial Phase: Percentage of Participants With Pruritus Scores | Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching], not really bothersome), 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with pruritus score was reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). | ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number). | Posted | Number | percentage of participants | Baseline, Weeks 2 and 4 LOCF |
|
|
|
| Secondary | Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores | Individual sign scores of erythema (abnormal redness of skin), scaling (scales attached to the scalp), plaque thickening (a thickening or elevation of a circumscribed lesion or plaque) were evaluated on a scale of 0-4; 0= none , 1= mild , 2=moderate , 3= severe, 4= very severe, where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling, and plaque thickening) scores were reported. Missing Clobex® shampoo data were imputed using last observation carried forward (LOCF). | ITT Population included the entire population who were enrolled and randomized. (i.e., assigned a kit number). | Posted | Number | percentage of participants | Baseline, Weeks 2 and 4 LOCF |
|
|
|
| Secondary | Maintenance Phase: Percentage of Participants Who Had First Relapse | The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Relapse was categorized into relapse or no relapse. Percentage of participants with relapse were reported. | ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit. Here, "number analyzed" refer to participants evaluable for this outcome at given timepoints. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse | Pruritus (itching sensation) score of were evaluated on a scale from 0 - 3 (0 = None [no itching], 1 = Mild [slight itching, not really bothersome], 2 = Moderate [definite itching that is somewhat bothersome; without loss of sleep], and 3 = severe [intense itching that has caused pronounced discomfort; night rest interrupted and excoriations of the skin from scratching may be present]) , where 0 indicates best and 3 indicates worst. Percentage of participants with scalp psoriasis pruritus score at first relapse was reported. | ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit. Overall number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 24 |
|
|
|
| Secondary | Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse | The first relapse was defined as the first time during the maintenance phase when participant presented with a GSS >2. Individual sign scores of erythema were evaluated on a scale of 0-4 (0= none, 1= mild, 2=moderate, 3= severe, 4= very severe), where 0 indicates best and 4 indicates worst. Percentage of participants with individual signs (erythema, scaling and plaque thickening) scores were reported. There were no participants in scaling category with 0 score. | ITT Population included the entire population who were enrolled and randomized (i.e., assigned a kit number). Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Number | percentage of participants | Baseline up to Week 24 |
|
|
|
| Secondary | Maintenance Phase: Percentage of Participants With Number of Relapses Experienced | Number of relapses of participants were categorized as 0; zero relapse, 1; one relapse, 2; two relapse, 3; three relapse, 4; two consecutive relapses. Percentage of participants with total number of relapses experienced during maintenance period was reported. | ITT worstcase population signifies participants who prematurely discontinued before the time of first relapse were considered as relapse at following visit. | Posted | Number | percentage of participants | Baseline up to Week 28 |
|
|
|
| 1 |
| 288 |
| 3 |
| 288 |
| 39 |
| 288 |
| EG001 | Maintenance Phase: Clobex® Shampoo | In maintenance double-blind phase, participants presented with a good efficacy (GSS <= 2) in initial phase were randomized to apply Clobetasol Propionate shampoo 0.05% (W/W) twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse [i.e., GSS > 2] participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). | 0 | 106 | 2 | 106 | 44 | 106 |
| EG002 | Maintenance Phase: Clobex® Vehicle Shampoo | In maintenance double-blind phase, participants presented with a good efficacy (GSS ≤ 2) in initial phase were randomized to apply Clobex® vehicle shampoo twice weekly up to 6 months (wherein weekly dose was not more than 50 grams [50 milliliter]). In case of relapse (i.e., GSS > 2) participants were re-entered to 4-week daily treatment with Clobetasol Propionate shampoo 0.05% (W/W). After this 4-week period of daily treatment, if GSS <= 2, participants were re-entering the maintenance regimen (twice a week). | 0 | 111 | 5 | 111 | 45 | 111 |
| Pneumonia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
|
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Gastroesophageal reflux Disease | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Odema Peripheral | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Lice Infestation | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Nesopharyngitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Chronic Sinusitis | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Otitis Externa | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Streptococcal Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA (8.1) | Non-systematic Assessment |
|
| Tendon Injury | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Back Injury | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Foreign Body in eye | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Post-traumatic Pain | Injury, poisoning and procedural complications | MedDRA (8.1) | Non-systematic Assessment |
|
| Electrocardiogram Abnormal | Investigations | MedDRA (8.1) | Non-systematic Assessment |
|
| Blood Cortisol Increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Metatarsalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Hair Colour Changes | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Skin Discomfort | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Hypotrichosis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Tinea Versicolour | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Cardiac Flutter | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.1) | Non-systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA (8.1) | Non-systematic Assessment |
|
| Dental Prosthesis Placement | Surgical and medical procedures | MedDRA (8.1) | Non-systematic Assessment |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Vulvovaginal Dryness | Reproductive system and breast disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
| Transient Ischemic Attack | Nervous system disorders | MedDRA (8.1) | Non-systematic Assessment |
|
Not provided
| D011083 |
| Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Baseline: Score 3 (Moderate) |
|
| Baseline: Score 4 (Severe) |
|
| Week 2-LOCF: Score 0 (Clear) |
|
| Week 2-LOCF: Score 1 (Very mild) |
|
| Week 2-LOCF: Score 2 (Mild) |
|
| Week 2-LOCF: Score 3 (Moderate) |
|
| Week 2-LOCF: Score 4 (Severe) |
|
| Week 4-LOCF: Score 0 (Clear) |
|
| Week 4-LOCF: Score 1 (Very mild) |
|
| Week 4-LOCF: Score 2 (Mild) |
|
| Week 4-LOCF: Score 3 (Moderate) |
|
| Week 4-LOCF: Score 4 (Severe) |
|
| Title | Measurements |
|---|---|
|
| Baseline: Score 3 (Severe) |
|
| Week 2- LOCF: Score 0 (None) |
|
| Week 2- LOCF: Score 1 (Mild) |
|
| Week 2- LOCF: Score 2 (Moderate) |
|
| Week 2- LOCF: Score 3 (Severe) |
|
| Week 4- LOCF: Score 0 (None) |
|
| Week 4- LOCF: Score 1 (Mild) |
|
| Week 4- LOCF: Score 2 (Moderate) |
|
| Week 4- LOCF: Score 3 (Severe) |
|
| Title | Measurements |
|---|---|
|
| Erythema at Baseline: Score 3 (Severe) |
|
| Erythema at Baseline: Score 4 (Very Severe) |
|
| Erythema at Week 2 - LOCF: Score 0 (None) |
|
| Erythema at Week 2 - LOCF: Score 1 (Mild) |
|
| Erythema at Week 2 - LOCF : 2: Moderate |
|
| Erythema at Week 2 - LOCF: Score 3 (Severe) |
|
| Erythema at Week 2 - LOCF: Score 4 (Very Severe) |
|
| Erythema at Week 4 - LOCF: Score 0 (None) |
|
| Erythema at Week 4 - LOCF: Score 1 (Mild) |
|
| Erythema at Week 4 - LOCF: Score 2 (Moderate) |
|
| Erythema at Week 4 - LOCF: Score 3 (Severe) |
|
| Erythema at Week 4 - LOCF: Score 4 (Very Severe) |
|
| Scaling at Baseline: Score 0 (None) |
|
| Scaling at Baseline: Score 1 (Mild) |
|
| Scaling at Baseline: Score 2 (Moderate) |
|
| Scaling at Baseline: Score 3 (Severe) |
|
| Scaling at Baseline: Score 4: (Very Severe) |
|
| Scaling at Week 2-LOCF: Score 0 (None) |
|
| Scaling at Week 2-LOCF: Score 1 (Mild) |
|
| Scaling at Week 2-LOCF: Score 2 (Moderate) |
|
| Scaling at Week 2-LOCF: Score 3 (Severe) |
|
| Scaling at Week 2-LOCF: Score 4 (Very Severe) |
|
| Scaling at Week 4-LOCF: Score 0 (None) |
|
| Scaling at Week 4-LOCF: Score 1 (Mild) |
|
| Scaling at Week 4-LOCF: Score 2 (Moderate) |
|
| Scaling at Week 4-LOCF: Score 3 (Severe) |
|
| Scaling at Week 4-LOCF: Score 4 (Very Severe) |
|
| Plaque Thickening at Baseline: Score 0 (None) |
|
| Plaque Thickening at Baseline: score 1 (Mild) |
|
| Plaque Thickening at Baseline: Score 2 (Moderate) |
|
| Plaque Thickening at Baseline: Score 3 (Severe) |
|
| Plaque Thickening at Baseline: Score 4 (Very Severe) |
|
| Plaque Thickening at Week 2-LOCF: Score 0 (None) |
|
| Plaque Thickening at Week 2-LOCF: Score 1 (Mild) |
|
| Plaque Thickening at Week 2-LOCF: Score 2 (Moderate) |
|
| Plaque Thickening at Week 2-LOCF: Score 3 (Severe) |
|
| Plaque Thickening at Week 2- LOCF: Score 4 (Very Severe) |
|
| Plaque Thickening at Week 4- LOCF: Score 0 (None) |
|
| Plaque Thickening at Week 4- LOCF: Score 1 (Mild) |
|
| Plaque Thickening at Week 4-LOCF: Score 2 (Moderate) |
|
| Plaque Thickening at Week 4- LOCF: Score 3 (Severe) |
|
| Plaque Thickening at Week 4- LOCF: Score 4 (Very Severe) |
|
| Week 4 : Relapse |
|
|
| Week 8 : Relapse |
|
|
| Week 12 : Relapse |
|
|
| Week 16 : Relapse |
|
|
| Week 20 : Relapse |
|
|
| Week 24 : Relapse |
|
|
| 2: Moderate |
|
| 3: Severe |
|
| Erythema: Score 2 (Moderate) |
|
| Erythema: Score 3 (Severe) |
|
| Erythema: Score 4 (Very Severe) |
|
| Scaling: Score 1 (Mild) |
|
| Scaling: Score 2 (Moderate) |
|
| Scaling: Score 3 (Severe) |
|
| Scaling: Score 4 (Very Severe) |
|
| Plaque Thickening: Score 0 (None) |
|
| Plaque Thickening: Score 1 (Mild) |
|
| Plaque Thickening: Score 2 (Moderate) |
|
| Plaque Thickening : Score 3 (Severe) |
|
| Plaque Thickening: Score 4 (Very Severe) |
|
| 2: Two Relapse |
|
| 3: Three Relapse |
|
| 4: Two Consecutive Relapses |
|