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An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events (AEs) | Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From Week -1 to Week 8 |
| Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. | 30 minutes after ACTH-challenge at Week 4 |
| Change in Albumin-corrected Serum Calcium From Baseline to Week 4 | Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From baseline to Week 4 |
| Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 | Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | From baseline to Week 4 |
| Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. |
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Inclusion Criteria (all subjects)
Inclusion Criteria (for subjects performing HPA axis assessment)
Exclusion Criteria (all subjects):
A history of hypersensitivity to any component of LEO 90100.
Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
PUVA therapy within 4 weeks prior to V1.
UVB therapy within 2 weeks prior to V1 or during the trial.
Exclusion Criteria (for subjects performing HPA axis assessment):
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| Name | Affiliation | Role |
|---|---|---|
| M Seyger, MD | UMC St Radboud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | United States | ||
| Redwood Family Dermatology |
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117 subjects were enrolled, this number includes all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were started on treatment in the LEO 90100 arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 90100 | LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2016 | Sep 28, 2018 |
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Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing. |
| From baseline to Week 4 |
| 30 and 60 minutes after ACTH-challenge at Week 4 |
| Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 | Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing. | From baseline to Week 4 |
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Week 4 |
| Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Week 4 |
| Percentage Change in PASI From Baseline to Week 4 | Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease. | From baseline to Week 4 |
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Week 4 |
| Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Week 4 |
| Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 | Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome. | From baseline to Week 4 |
| Santa Rosa |
| California |
| 95403-2805 |
| United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059-3526 | United States |
| Greenwich Village Dermatology | New York | New York | 10012 | United States |
| Skin Speciality Dermatology | New York | New York | 10155 | United States |
| Dermatology Treatment and Research Center PA | Dallas | Texas | 75230-5808 | United States |
| UMC St Radboud | Nijmegen | 6525 | Netherlands |
| MULTIKLINIKA SALUTE Sp zo.o. | Katowice | 40-123 | Poland |
| Spitalul Clinic de Boli Infectioase si Tropicale | Bucharest | 030303 | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
Of the 117 subjects who were enrolled in the trial and screened, 106 subjects met all inclusion criteria and none of the exclusion criteria. These 106 subjects comprise the Baseline Analysis Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90100 | LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Fitzpatrick Skin Type | Fitzpatrick skin type is based on skin reaction to first 30-45 minutes sun exposure after a winter with no sun exposure: Type I: Unexposed skin color: white, always burns easily, never tans. Type II: Unexposed skin color: white, always burns easily, tans minimally. Type III: Unexposed skin color: white, burns moderately, tans gradually (light brown). Type IV: Unexposed skin color: white, burns minimally, always tans well (moderate brown). Type V: Unexposed skin color: brown, rarely burns, tans profusely (dark brown). Type VI: Unexposed skin color: black, never burns, deeply pigmented. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| Duration of plaque psoriasis | Mean | Standard Deviation | years |
|
| 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 | Number of Subjects With Adverse Events (AEs) | Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | Safety analysis set | Posted | Count of Participants | Participants | From Week -1 to Week 8 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. | Per protocol analysis set | Posted | Count of Participants | Participants | 30 minutes after ACTH-challenge at Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Albumin-corrected Serum Calcium From Baseline to Week 4 | Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | Safety analysis set | Posted | Mean | Standard Deviation | mmol/L | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4 | Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available. | 24-hour urine HPA set | Posted | Mean | Standard Deviation | mmol/24hr | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4 | Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing. | 24-hour urine in HPA set | Posted | Mean | Standard Deviation | mmol/g | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4 | Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline. | Per protocol analysis set | Posted | Count of Participants | Participants | 30 and 60 minutes after ACTH-challenge at Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4 | Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing. | Spot urine non-HPA set | Posted | Mean | Standard Deviation | mmol/g | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Count of Participants | Participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp | Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Count of Participants | Participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in PASI From Baseline to Week 4 | Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | Percentage change in PASI | From baseline to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Count of Participants | Participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4 | Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Count of Participants | Participants | Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4 | Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome. | Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure. | Posted | Mean | Standard Deviation | mm on VAS scale | From baseline to Week 4 |
|
|
From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEO 90100 | LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional HPA axis assessments and constitute the per protocol analysis set. | 0 | 106 | 0 | 106 | 22 | 106 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Product physical consistency issue | General disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Myopia | Eye disorders | MedDRA 18.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.0 | Non-systematic Assessment |
| |
| Haemangioma of liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 18.0 | Non-systematic Assessment |
|
LEO acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Specialist | LEO Pharma A/S | +45 44945888 | disclosure@leo-pharma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2018 | Sep 28, 2018 | SAP_000.pdf |
| Unknown or Not Reported |
|
| Other |
|
| United States |
|
| Poland |
|
| Type III |
|
| Type IV |
|
| Type V |
|
| Title | Measurements |
|---|---|
|
| Impetigo |
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| Oral herpes |
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| Pharyngitis |
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| Pulpitis dental |
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| Rhinitis |
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| Acne |
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| Erythema |
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| Pruritus generalised |
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| Psoriasis |
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| Skin reaction |
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| Application site pain |
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| Product physical consistency issue |
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| Arthralgia |
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| Myalgia |
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| Myopia |
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| Arthropod bite |
|
| Haemangioma of liver |
|
| Skin neoplasm excision |
|
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