PsoriasisPhase 1NCT05523011
Safety and Tolerability Study of MSC Exosome Ointment
A Phase 1 study testing Exosome ointment in people with Psoriasis, run by Paracrine Therapeutics Dermatology Pte. Ltd. at 1 site in Singapore.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Exosome ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Mar 2022to 5 Apr 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
- had a negative pregnancy test at screening
- remained abstinent or used contraceptive methods during the treatment period and continued for at least 30 days (one menstrual cycle) after the last treatment dose.
Who cannot join
- Subject had any serious skin condition that was not well controlled.
- Subject was currently using topical treatments.
- Pregnant or breast-feeding women.
- Subject had received phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive / immune modulative drugs, cytostatic / cytotoxic drugs, cyclosporine, or methotrexate within 30 days prior to the first application of the study product.
- Subject was currently using any medications including biologics or undergoing treatment known to affect skin conditions.
- Subject had any other clinically significant laboratory abnormalities, co-morbidities or psychiatric conditions that would place the subject at increased risk or confound the objectives of the study.
- Subject had used any investigational drugs or biologics and/or participated in any clinical trial within the last 60 days before the day of the first dose of the study drug or was taking part in a non-medication study that would interfere with study compliance or outcome assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Determine Safety and Tolerability of the Topical Application of Mesenchymal Stem/Stromal Cell (MSC) Exosome Ointment to Treat Psoriasis in Healthy Volunteers
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:
- Frequency of treatment-emergent adverse events (TEAEs)
- The incidence rate of local skin responses (LSR, i.e., erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration, hyperpigmentation, hypopigmentation, and scarring) [Time Frame: Days 1 and 21]
- Changes from baseline in blood parameters (including hematology, chemistry, and other inflammation parameters such as C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) [Time Frame: Days 1 and 21]
Read the detailed description
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:
- A Screening Period of 1 day (Day 1)
- A Treatment Period of 20 days (Day 1 to 20)
- An End of Study (EOS) Period of 1 day (Day 21 [+3 days]).
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:
- Inclusion/exclusion criteria assessments
- Vital signs
- Medical history
- Demographic data review
- Standard hematology panel
- Renal panel
- Liver function test
- Inflammatory blood examinations
- Pregnancy test (if applicable)
- Concomitant medications
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.
- Conditions
- Psoriasis
- Being tested
- Exosome ointment
- Keywords
- Mesenchymal stem/stromal cell, Exosome, Exosome ointment, Topical application, Safety and Tolerability, Extracellular vesicle
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome ointmentDrug
100 µg MSC exosomes/g ointment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Exosome ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Day 1 - 21+3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start8 Mar 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm, open-label study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracrine Therapeutics Dermatology Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Nisha Suyien Chandran, Dr., Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523011
- Sponsor's protocol ID
- PTD2021P001
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2022
- Last updated
- 31 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of IPD is on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Determine Safety and Tolerability of the Topical Application of Mesenchymal Stem/Stromal Cell (MSC) Exosome Ointment to Treat Psoriasis in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05523011
- Acronym / sponsor ID
- PTD2021P001
- Conditions
- Psoriasis
- Keywords
- Mesenchymal stem/stromal cell, Exosome, Exosome ointment, Topical application, Safety and Tolerability, Extracellular vesicle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Paracrine Therapeutics Dermatology Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Frequency of treatment-emergent adverse events (TEAEs)
- The incidence rate of local skin responses (LSR, i.e., erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration, hyperpigmentation, hypopigmentation, and scarring) [Time Frame: Days 1 and 21]
- Changes from baseline in blood parameters (including hematology, chemistry, and other inflammation parameters such as C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) [Time Frame: Days 1 and 21]
Detailed description
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:
- A Screening Period of 1 day (Day 1)
- A Treatment Period of 20 days (Day 1 to 20)
- An End of Study (EOS) Period of 1 day (Day 21 [+3 days]).
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:
- Inclusion/exclusion criteria assessments
- Vital signs
- Medical history
- Demographic data review
- Standard hematology panel
- Renal panel
- Liver function test
- Inflammatory blood examinations
- Pregnancy test (if applicable)
- Concomitant medications
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, open-label study
| Arm | Type | Receives |
|---|---|---|
| Exosome Ointment | Experimental | Drug: Exosome ointmentThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Subject had any serious skin condition that was not well controlled.
- Subject was currently using topical treatments.
- Pregnant or breast-feeding women.
- Subject had received phototherapy, oral corticosteroids, oral retinoid, oral immunosuppressive / immune modulative drugs, cytostatic / cytotoxic drugs, cyclosporine, or methotrexate within 30 days prior to the first application of the study product.
- Subject was currently using any medications including biologics or undergoing treatment known to affect skin conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosome ointment100 µg MSC exosomes/g ointment | Drug | Exosome Ointment |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 - 20
All through the treatment period, the subjects completed the Subject Diary to capture the frequency of TEAEs.
Change From Baseline in the Systolic Blood Pressure After 20 Days of Treatment
Time frame: Day 1 - 21+3
Systolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Diastolic Blood Pressure After 20 Days of Treatment
Time frame: Day 1 - 21+3
Diastolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Heart Rate After 20 Days of Treatment
Time frame: Day 1 - 21+3
Heart rate (beats/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Respiratory Rate After 20 Days of Treatment
Time frame: Day 1 - 21+3
Respiratory rate (breaths/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Body Temperature After 20 Days of Treatment
Time frame: Day 1 - 21+3
Body temperature (°C) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Basophils After 20 Days of Treatment
Time frame: Day 1 - 21+3
Basophils (10^9 Basophils /L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Eosinophils After 20 Days of Treatment
Time frame: Day 1 - 21+3
Eosinophils (10^9 Eosinophils/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Hematocrit After 20 Days of Treatment
Time frame: Day 1 - 21+3
hematocrit(%) assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Hemoglobin After 20 Days of Treatment
Time frame: Day 1 - 21+3
Hemoglobin (g/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Lymphocytes After 20 Days of Treatment
Time frame: Day 1 - 21+3
Lymphocytes (10^9 Lymphocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Monocytes After 20 Days of Treatment
Time frame: Day 1 - 21+3
Monocytes (10^9 Monocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Red Blood Cell After 20 Days of Treatment
Time frame: Day 1 - 21+3
Red blood cell (10^12 Red blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the White Blood Cell After 20 Days of Treatment
Time frame: Day 1 - 21+3
White Blood Cell (10^9 White blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Bicarbonate After 20 Days of Treatment
Time frame: Day 1 - 21+3
Bicarbonate (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Blood Urea Nitrogen After 20 Days of Treatment
Time frame: Day 1 - 21+3
Blood urea nitrogen (mg/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Calcium After 20 Days of Treatment
Time frame: Day 1 - 21+3
Calcium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Chloride After 20 Days of Treatment
Time frame: Day 1 - 21+3
Chloride (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Creatinine After 20 Days of Treatment
Time frame: Day 1 - 21+3
Creatinine (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Glucose After 20 Days of Treatment
Time frame: Day 1 - 21+3
Glucose (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Potassium After 20 Days of Treatment
Time frame: Day 1 - 21+3
Potassium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Sodium After 20 Days of Treatment
Time frame: Day 1 - 21+3
Sodium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Alanine Transaminase After 20 Days of Treatment
Time frame: Day 1 - 21+3
Alanine transaminase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Albumin After 20 Days of Treatment
Time frame: Day 1 - 21+3
Albumin (g/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Alkaline Phosphatase After 20 Days of Treatment
Time frame: Day 1 - 21+3
Alkaline phosphatase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Aspartate Aminotransferase After 20 Days of Treatment
Time frame: Day 1 - 21+3
Aspartate aminotransferase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Direct Bilirubin After 20 Days of Treatment
Time frame: Day 1 - 21+3
Direct bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Total Bilirubin After 20 Days of Treatment
Time frame: Day 1 - 21+3
Total bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the C-reactive Protein After 20 Days of Treatment
Time frame: Day 1 - 21+3
C-reactive protein (mg/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Change From Baseline in the Erythrocyte Sedimentation Rate After 20 Days of Treatment
Time frame: Day 1 - 21+3
Erythrocyte sedimentation rate (mm/hr) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Assessment of the Dryness of the Area of Application
Time frame: Day 1 - 21+3
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
Assessment of the Oozing/Crusting of the Area of Application
Time frame: Day 1 - 21+3
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
Assessment of the Redness of the Area of Application
Time frame: Day 1 - 21+3
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
Assessment of the Scratch Marks of the Area of Application
Time frame: Day 1 - 21+3
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
Assessment of the Skin Thickening of the Area of Application
Time frame: Day 1 - 21+3
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
Assessment of the Swelling of the Area of Application
Time frame: Day 1 - 21+3
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).
Assessment of the Itch of the Area of Application
Time frame: Day 1 - 21+3
Subjective symptoms: The identified area of application was assessed for the subjective symptom itch, graded from 0 (no itch) to 10 (worst imaginable itch)
Assessment of the Sleeplessness
Time frame: Day 1 - 21+3
Subjective symptoms: The participant was assessed for the subjective symptom sleeplessness and graded from 0 (no sleeplessness) to 10 (worst imaginable sleeplessness)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Sharing of IPD is on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Suyien Chandran, Dr. principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exosome ointment in people with Psoriasis, run by Paracrine Therapeutics Dermatology Pte. Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 - 20). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.