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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
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This phase 1 study aims to evaluate the safety and tolerability of the application of the MSC exosome ointment with repeated topical application on adult healthy subjects (TID from Day 1 to 20). The results of this study were to provide the first clinical information on the drug's safety and inform the selection of administration of exosome ointment to be evaluated in subsequent clinical studies. The endpoints included to assess the safety and tolerability of exosome ointment for topical application in healthy adult volunteers are:
This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Conference on Harmonization (ICH), Good Clinical Practice (GCP) Guidelines, and other applicable laws and regulations.
This was a Phase 1, single-center, open-label study. After signing an ICF, subjects underwent screening procedures on Day 1 prior to the first study product application to determine eligibility. Once eligible, all subjects (n=10) received topical treatment with the MSC exosome ointment immediately followed by Vesiderm liposome cream TID on the forearm with a gap of 4 hours between doses.
The study consisted of the following periods:
Screening Period
The subjects were screened for eligibility on Day 1 prior to the application of the study product. Subjects were asked to sign the ICF after having the study described to them. After obtaining written informed consent, subjects underwent the following screening procedures for participation in the study:
Identification, visual assessment, and photography of application area
A trained expert evaluator (an Investigator or designee) identified the area of study product application and performed visual assessments which were carried out using an adapted version of SCORing Atopic Dermatitis (SCORAD) scale and visual assessment score (VAS). A photograph of the area of application was also taken using a dedicated compact digital camera at the clinic where subject visits were done.
Treatment Period
After confirmation of the application site, the subjects applied exosome ointment along with Vesiderm liposome cream (TID per day). Each day (from Day 1 to 20), the study product was applied with a gap of 4 hours between each dose to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream was meant to keep the application site moisturized.
All through the treatment period, the subjects completed the Subject Diary to capture adverse events (AEs; skin-related and other), concomitant medications, and time of study product application.
The site coordinator called the subjects every 3 days (Days 3, 6, 9, 12, 15, and 18) to follow up on the investigational product's (IP) compliance, and if subjects had any adverse events or had taken any concomitant medications during the period. Any AEs reported by the subject during the calls were to be referred to the investigator for appropriate review and follow-up.
End of Study (EOS) Period
The EOS period was on Day 21 (+3 days). The subjects visited the clinic on this day for the assessments such as vital signs, blood examinations (hematology, chemistry, and inflammatory blood examinations), photographs of the area of application, visual assessment of the area of application, AEs, and concomitant medications used.
The assessments at this visit were also to be conducted in case of early termination or withdrawal of any subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosome Ointment | Experimental | The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosome ointment | Drug | 100 µg MSC exosomes/g ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All through the treatment period, the subjects completed the Subject Diary to capture the frequency of TEAEs. | Day 1 - 20 |
| Change From Baseline in the Systolic Blood Pressure After 20 Days of Treatment | Systolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Diastolic Blood Pressure After 20 Days of Treatment | Diastolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Heart Rate After 20 Days of Treatment | Heart rate (beats/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Respiratory Rate After 20 Days of Treatment | Respiratory rate (breaths/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Body Temperature After 20 Days of Treatment | Body temperature (°C) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Basophils After 20 Days of Treatment | Basophils (10^9 Basophils /L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) |
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Inclusion Criteria:
Signed ICF prior to entering the study or undergoing any study procedures.
Male or female, >21 years of age at the time of signing the informed consent.
Subject who had been fully vaccinated for COVID-19 and was not under quarantine or Stay Home Notice or on medical leave.
Subject who was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Subject was able to read and write in the English language.
For women who were not postmenopausal (> 12 months of non-therapy induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nisha Suyien Chandran, Dr. | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
Sharing of IPD is on a case-by-case basis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exosome Ointment | The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized. Exosome ointment: 100 µg MSC exosomes/g ointment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exosome Ointment | The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized. Exosome ointment: 100 µg MSC exosomes/g ointment |
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | All through the treatment period, the subjects completed the Subject Diary to capture the frequency of TEAEs. | Posted | Count of Participants | Participants | Day 1 - 20 |
|
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Treatment period (Day1-Day20)
All through the treatment period, the subjects completed the Subject Diary to capture the frequency of adverse event
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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 | Exosome Ointment | The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized. Exosome ointment: 100 µg MSC exosomes/g ointment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lai Ruenn Chai | Paracrine Therapeutics Private Limited | +6593375977 | ruennchai.lai@paracrinetherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2023 | Mar 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Single-center, single-arm, open-label study
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Open-label
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| Day 1 - 21+3 |
| Change From Baseline in the Eosinophils After 20 Days of Treatment | Eosinophils (10^9 Eosinophils/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Hematocrit After 20 Days of Treatment | hematocrit(%) assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Hemoglobin After 20 Days of Treatment | Hemoglobin (g/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Lymphocytes After 20 Days of Treatment | Lymphocytes (10^9 Lymphocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Monocytes After 20 Days of Treatment | Monocytes (10^9 Monocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Red Blood Cell After 20 Days of Treatment | Red blood cell (10^12 Red blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the White Blood Cell After 20 Days of Treatment | White Blood Cell (10^9 White blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Bicarbonate After 20 Days of Treatment | Bicarbonate (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Blood Urea Nitrogen After 20 Days of Treatment | Blood urea nitrogen (mg/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Calcium After 20 Days of Treatment | Calcium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Chloride After 20 Days of Treatment | Chloride (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Creatinine After 20 Days of Treatment | Creatinine (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Glucose After 20 Days of Treatment | Glucose (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Potassium After 20 Days of Treatment | Potassium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Sodium After 20 Days of Treatment | Sodium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Alanine Transaminase After 20 Days of Treatment | Alanine transaminase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Albumin After 20 Days of Treatment | Albumin (g/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Alkaline Phosphatase After 20 Days of Treatment | Alkaline phosphatase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Aspartate Aminotransferase After 20 Days of Treatment | Aspartate aminotransferase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Direct Bilirubin After 20 Days of Treatment | Direct bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Total Bilirubin After 20 Days of Treatment | Total bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the C-reactive Protein After 20 Days of Treatment | C-reactive protein (mg/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Change From Baseline in the Erythrocyte Sedimentation Rate After 20 Days of Treatment | Erythrocyte sedimentation rate (mm/hr) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Day 1 - 21+3 |
| Assessment of the Dryness of the Area of Application | Visual assessments of the dryness of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Day 1 - 21+3 |
| Assessment of the Oozing/Crusting of the Area of Application | Visual assessments of the oozing/crusting of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Day 1 - 21+3 |
| Assessment of the Redness of the Area of Application | Visual assessments of the rednessof the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Day 1 - 21+3 |
| Assessment of the Scratch Marks of the Area of Application | Visual assessments of the scratch marks the area of application were carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Day 1 - 21+3 |
| Assessment of the Skin Thickening of the Area of Application | Visual assessments of the skin thickening the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Day 1 - 21+3 |
| Assessment of the Swelling of the Area of Application | Visual assessments of the swelling of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). | Day 1 - 21+3 |
| Assessment of the Itch of the Area of Application | Subjective symptoms: The identified area of application was assessed for the subjective symptom itch, graded from 0 (no itch) to 10 (worst imaginable itch) | Day 1 - 21+3 |
| Assessment of the Sleeplessness | Subjective symptoms: The participant was assessed for the subjective symptom sleeplessness and graded from 0 (no sleeplessness) to 10 (worst imaginable sleeplessness) | Day 1 - 21+3 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hematology-Basophils | number of cell per liter of blood | Mean | Standard Deviation | 10^9 Basophils/L |
|
| Hematology-Eosinophils | number of cell per liter of blood | Mean | Standard Deviation | 10^9 Eosinophils/L |
|
| Hematology-Hematocrit | Mean | Standard Deviation | % |
|
| Hematology-Hemoglobin | Mean | Standard Deviation | g/dL |
|
| Hematology-Lymphocytes | Mean | Standard Deviation | 10^9 Lymphocytes/L |
|
| Hematology-Monocytes | Mean | Standard Deviation | 10^9 Monocytes/L |
|
| Hematology-Red Blood Cell | Mean | Standard Deviation | 10^12 Red blood cells/L |
|
| Hematology-White Blood Cell | Mean | Standard Deviation | 10^9 White blood cells/L |
|
| Renal Panel-Bicarbonate | Mean | Standard Deviation | mmol/L |
|
| Renal Panel-Blood urea nitrogen | Mean | Standard Deviation | mg/dL |
|
| Renal Panel-Calcium | Mean | Standard Deviation | mmol/L |
|
| Renal Panel-Chloride | Mean | Standard Deviation | mmol/L |
|
| Renal Panel-Creatinine | Mean | Standard Deviation | umol/L |
|
| Renal Panel-Glucose | Mean | Standard Deviation | mmol/L |
|
| Renal Panel-Potassium | Mean | Standard Deviation | mmol/L |
|
| Renal Panel-Sodium | Mean | Standard Deviation | mmol/L |
|
| Liver Function Test-Alanine transaminase | Mean | Standard Deviation | U/L |
|
| Liver Function Test-Albumin | Mean | Standard Deviation | g/L |
|
| Liver Function Test-Alkaline phosphatase | Mean | Standard Deviation | U/L |
|
| Liver Function Test-Aspartate aminotransferase | Mean | Standard Deviation | U/L |
|
| Liver Function Test-Direct bilirubin | Mean | Standard Deviation | umol/L |
|
| Liver Function Test-Total bilirubin | Mean | Standard Deviation | umol/L |
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| Inflammatory Blood Examinations-C-reactive protein | Mean | Standard Deviation | mg/L |
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| Inflammatory Blood Examinations-Erythrocyte sedimentation rate | Mean | Standard Deviation | mm/hr |
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| Vital Signs-Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Vital Signs-Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Vital Signs-Heart Rate | Mean | Standard Deviation | beats/min |
|
| Vital Signs-Respiratory Rate | Mean | Standard Deviation | breaths/min |
|
| Vital Signs-Body Temperature | Mean | Standard Deviation | degree Celcius |
|
| SCORAD-Dryness | Count of Participants | Participants |
|
| SCORAD-Oozing/Crusting | Count of Participants | Participants |
|
| SCORAD-Redness | Count of Participants | Participants |
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| SCORAD-Scratch marks | Count of Participants | Participants |
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| SCORAD-Skin thickening | Count of Participants | Participants |
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| SCORAD-Swelling | Count of Participants | Participants |
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| VAS-Itch | 0 (no itch) to 10 (worst imaginable itch) | Mean | Standard Deviation | units on a scale |
|
| VAS-Sleeplessness | 0 (no sleeplessness) to 10 (worst imaginable sleeplessness) | Mean | Standard Deviation | units on a scale |
|
| Counts |
|---|
| Participants |
|
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| Primary | Change From Baseline in the Systolic Blood Pressure After 20 Days of Treatment | Systolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmHg | Day 1 - 21+3 |
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|
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| Primary | Change From Baseline in the Diastolic Blood Pressure After 20 Days of Treatment | Diastolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmHg | Day 1 - 21+3 |
|
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| Primary | Change From Baseline in the Heart Rate After 20 Days of Treatment | Heart rate (beats/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | beats/min | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Respiratory Rate After 20 Days of Treatment | Respiratory rate (breaths/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | breaths/min | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Body Temperature After 20 Days of Treatment | Body temperature (°C) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | degree Celcius | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Basophils After 20 Days of Treatment | Basophils (10^9 Basophils /L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^9 Basophils /L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Eosinophils After 20 Days of Treatment | Eosinophils (10^9 Eosinophils/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^9 Eosinophils/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Hematocrit After 20 Days of Treatment | hematocrit(%) assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | percentage change from baseline | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Hemoglobin After 20 Days of Treatment | Hemoglobin (g/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | g/dL | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Lymphocytes After 20 Days of Treatment | Lymphocytes (10^9 Lymphocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^9 Lymphocytes/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Monocytes After 20 Days of Treatment | Monocytes (10^9 Monocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^9 Monocytes/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Red Blood Cell After 20 Days of Treatment | Red blood cell (10^12 Red blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^12 Red blood cells/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the White Blood Cell After 20 Days of Treatment | White Blood Cell (10^9 White blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | 10^9 White blood cells/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Bicarbonate After 20 Days of Treatment | Bicarbonate (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Blood Urea Nitrogen After 20 Days of Treatment | Blood urea nitrogen (mg/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mg/dL | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Calcium After 20 Days of Treatment | Calcium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Chloride After 20 Days of Treatment | Chloride (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Creatinine After 20 Days of Treatment | Creatinine (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | umol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Glucose After 20 Days of Treatment | Glucose (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Potassium After 20 Days of Treatment | Potassium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Sodium After 20 Days of Treatment | Sodium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mmol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Alanine Transaminase After 20 Days of Treatment | Alanine transaminase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | U/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Albumin After 20 Days of Treatment | Albumin (g/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | g/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Alkaline Phosphatase After 20 Days of Treatment | Alkaline phosphatase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | U/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Aspartate Aminotransferase After 20 Days of Treatment | Aspartate aminotransferase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | U/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Direct Bilirubin After 20 Days of Treatment | Direct bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | umol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Total Bilirubin After 20 Days of Treatment | Total bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | umol/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the C-reactive Protein After 20 Days of Treatment | C-reactive protein (mg/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mg/L | Day 1 - 21+3 |
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| Primary | Change From Baseline in the Erythrocyte Sedimentation Rate After 20 Days of Treatment | Erythrocyte sedimentation rate (mm/hr) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days) | Posted | Mean | Standard Deviation | mm/hr | Day 1 - 21+3 |
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|
|
| Primary | Assessment of the Dryness of the Area of Application | Visual assessments of the dryness of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Posted | Count of Participants | Participants | Day 1 - 21+3 |
|
|
|
| Primary | Assessment of the Oozing/Crusting of the Area of Application | Visual assessments of the oozing/crusting of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Posted | Count of Participants | Participants | Day 1 - 21+3 |
|
|
|
| Primary | Assessment of the Redness of the Area of Application | Visual assessments of the rednessof the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Posted | Count of Participants | Participants | Day 1 - 21+3 |
|
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| Primary | Assessment of the Scratch Marks of the Area of Application | Visual assessments of the scratch marks the area of application were carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Posted | Count of Participants | Participants | Day 1 - 21+3 |
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| Primary | Assessment of the Skin Thickening of the Area of Application | Visual assessments of the skin thickening the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe | Posted | Count of Participants | Participants | Day 1 - 21+3 |
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| Primary | Assessment of the Swelling of the Area of Application | Visual assessments of the swelling of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). | Posted | Count of Participants | Participants | Day 1 - 21+3 |
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| Primary | Assessment of the Itch of the Area of Application | Subjective symptoms: The identified area of application was assessed for the subjective symptom itch, graded from 0 (no itch) to 10 (worst imaginable itch) | Posted | Mean | Standard Deviation | score on a scale | Day 1 - 21+3 |
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| Primary | Assessment of the Sleeplessness | Subjective symptoms: The participant was assessed for the subjective symptom sleeplessness and graded from 0 (no sleeplessness) to 10 (worst imaginable sleeplessness) | Posted | Mean | Standard Deviation | score on a scale | Day 1 - 21+3 |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided
| 3(Severe) |
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| Day 21+3 |
|
| 3(Severe) |
|
| Day 21+3 |
|
| 3(Severe) |
|
| Day 21+3 |
|
| 3(Severe) |
|
| Day 21+3 |
|
| 3(Severe) |
|
| Day 21+3 |
|
| 3(Severe) |
|
| Day 21+3 |
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