Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this randomized, double blind, placebo controlled, parallel group study is to compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis (AD).
This was a randomized, vehicle-controlled, double-blind, parallel-group, multicenter, Phase 2b study to investigate the safety and efficacy of topically administered DS107 cream and the dose-response relationship between DS107 cream and vehicle cream in patients 18 years and older with mild to moderate AD.
Approximately 300 patients (100 per treatment group), with mild to moderate AD were to be included in this study. All patients signed the patient information sheet (PIS)/informed consent form (ICF) and underwent screening for study eligibility. Eligible patients were randomized (1:1:1) to receive 1% DS107 cream, 5% DS107 cream or, vehicle cream:
Treatment Group A: 1% DS107 cream Treatment Group B: 5% DS107 cream Treatment Group C: Vehicle cream Study cream was to be applied topically to all affected or commonly affected areas twice daily (BID) for 8 weeks. To maintain the double-blind conditions, the DS107 and vehicle creams were identical in appearance. During their participation, patients were to come to the clinic on 7 occasions: Screening, Baseline, and at Weeks 2, 4, 6, 8 (end of treatment), and 10 (follow-up).
At the start of the study, areas for treatment were defined, DS107 or vehicle cream was then applied to those areas (and any newly affected areas) throughout the 8-week treatment period. Patients were instructed to apply the study cream liberally to the affected area in the morning and the evening. Emollients could be applied to other areas of dry skin that were not in the defined treatment area. On the days of clinic visits, patients were instructed to abstain from applying study cream for 6 hours prior to the visit and then to apply study cream as soon as possible after the clinic visit.
Once enrolled, patients were restricted from using any other treatment for AD. Any medication (prescription and over-the-counter [OTC] drugs) or therapeutic intervention deemed necessary for the patient, and which in the opinion of the investigator did not interfere with the safety and efficacy evaluations, could be continued unless they were included in the prohibited list of medications and therapeutic regimens.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle Cream | Placebo Comparator | Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks |
|
| 1% DS107 Cream | Experimental | 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks |
|
| 5% DS107 Cream | Experimental | 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS107 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8 | Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant. | Baseline and Week 8 |
| Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8 | Change from baseline in EASI in treated population compared to vehicle population at Week 8. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 | Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were asked to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Markus Weissbach, MD, Ph.D | DS Biopharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Biopharma Site | East Windsor | New Jersey | 08520 | United States | ||
| DS Biopharma Site |
Eligible patients were randomized (1:1:1) to receive either 1% DS107 cream, 5% DS107 cream or, vehicle cream.
Approximately 300 patients (100 per treatment group), with mild to moderate Atopic Dermatitis (AD) were to be included in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Cream | Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream |
| FG001 | 1% DS107 Cream | 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
| FG002 | 5% DS107 Cream | 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS): All patients who were randomized to the study and received at least one dose of study cream. FAS was the primary analysis population for efficacy endpoints.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Cream | Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream |
| BG001 | 1% DS107 Cream | 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
| 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 | Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8 | Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant. | The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 8 |
Up to 10 weeks
Any undesirable experience occurring to a patient who has signed the Informed Consent Form (ICF) and has taken their first dose of the study drug, whether or not considered related to the investigational Investigational Medicinal Product(s) (IMP). All Adverse Events (AEs) must be recorded in the case report form, defining relationship to IMP and severity.
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 | Vehicle Cream | Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Monocytosis | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | DS Biopharma | +35312933590 | regulatory.dsbiopharma@dsbiopharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2017 | Aug 3, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2017 | Aug 3, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle cream |
| Other |
|
|
| Baseline, Week 2, Week 6 and Week 10 |
| Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. | • Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable) | 10 weeks |
| Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. | Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| Baseline, Week 2, Week 4, Week 6 and Week 10 |
| Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. | Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| 10 weeks |
| Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. | Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. The IGA scale awards a score of 0˗4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment. | 10 weeks |
| Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. | The Global Investigator Assessment scale (IGA) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant. | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
| Markham |
| L3P 1X2 |
| Canada |
| DS Biopharma Site | Cape Town | 7700 | South Africa |
| Investigator Discretion |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Other: |
|
| BG002 | 5% DS107 Cream | 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vehicle Cream | Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks Vehicle cream |
| OG001 | 1% DS107 Cream | 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
| OG002 | 5% DS107 Cream | 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 |
|
|
|
| Primary | Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8 | Change from baseline in EASI in treated population compared to vehicle population at Week 8. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 8 |
|
|
|
| Secondary | Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10 | Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were asked to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant. | The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 6 and Week 10 |
|
|
|
| Secondary | Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10. | • Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable) | The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Number | Proportion of participants | 10 weeks |
|
|
|
| Secondary | Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10. | Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 6 and Week 10 |
|
|
|
| Secondary | Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. | Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
| The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Number | Proportion of participants | 10 weeks |
|
|
|
| Secondary | Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. | Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. The IGA scale awards a score of 0˗4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment. | The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Number | Proportion of participants | 10 weeks |
|
|
|
| Secondary | Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10. | The Global Investigator Assessment scale (IGA) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant. | The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10 |
|
|
|
| 0 |
| 106 |
| 1 |
| 106 |
| 38 |
| 106 |
| EG001 | 1% DS107 Cream | 1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 | 0 | 110 | 1 | 110 | 48 | 110 |
| EG002 | 5% DS107 Cream | 5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks DS107 | 0 | 111 | 0 | 111 | 40 | 111 |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
|
| Colitis Ulcerative | Gastrointestinal disorders | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Hiatus Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Application Site Erythema | General disorders | Systematic Assessment |
|
| Application Site Inflammation | General disorders | Systematic Assessment |
|
| Application Site Pain | General disorders | Systematic Assessment |
|
| Application Site Pruritus | General disorders | Systematic Assessment |
|
| Application Site Reaction | General disorders | Systematic Assessment |
|
| Application Site Swelling | General disorders | Systematic Assessment |
|
| Influenza Like Illness | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Peripheral Swelling | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Xerosis | General disorders | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Dermatitis Infected | Infections and infestations | Systematic Assessment |
|
| Folliculitis | Infections and infestations | Systematic Assessment |
|
| Fungal Infection | Infections and infestations | Systematic Assessment |
|
| Furuncle | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | Systematic Assessment |
|
| Helicobacter Zoster | Infections and infestations | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Systematic Assessment |
|
| Impetigo | Infections and infestations | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Otitis Media Acute | Infections and infestations | Systematic Assessment |
|
| Perineal Infection | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Skin Bacterial Infection | Infections and infestations | Systematic Assessment |
|
| Soft Tissue Infection | Infections and infestations | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cataract Operation Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Heat Stroke | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Tooth Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood Creatine Phosphokinase | Investigations | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | Systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Adenoma Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Tension Headache | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Intertrigo | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash Erythematous | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Fissures | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Tightness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | Systematic Assessment |
|
| Tooth Extraction | Surgical and medical procedures | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Week 8 |
|
| Week 10 |
|
| Title | Measurements |
|---|---|
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
|
| Week 6 |
|
| Week 10 |
|
| Title | Measurements |
|---|---|
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
| Title | Measurements |
|---|---|
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|
|
| Week 6 |
|
| Week 8 |
|
| Week 10 |
|