Phase 1 N=10 Treatment

Safety and Tolerability Study of MSC Exosome Ointment

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT05523011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Exosome ointment (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Paracrine Therapeutics Dermatology Pte. Ltd.
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs)	—	—
PRIMARY Change From Baseline in the Systolic Blood Pressure After 20 Days of Treatment	-4.3	—
PRIMARY Change From Baseline in the Diastolic Blood Pressure After 20 Days of Treatment	-9.4	—
PRIMARY Change From Baseline in the Heart Rate After 20 Days of Treatment	2.3	—
PRIMARY Change From Baseline in the Respiratory Rate After 20 Days of Treatment	0.5	—
PRIMARY Change From Baseline in the Body Temperature After 20 Days of Treatment	-0.07	—
PRIMARY Change From Baseline in the Basophils After 20 Days of Treatment	0.010	—
PRIMARY Change From Baseline in the Eosinophils After 20 Days of Treatment	0.005	—
PRIMARY Change From Baseline in the Hematocrit After 20 Days of Treatment	0.44	—
PRIMARY Change From Baseline in the Hemoglobin After 20 Days of Treatment	0.13	—
PRIMARY Change From Baseline in the Lymphocytes After 20 Days of Treatment	0.059	—
PRIMARY Change From Baseline in the Monocytes After 20 Days of Treatment	-0.004	—
PRIMARY Change From Baseline in the Red Blood Cell After 20 Days of Treatment	0.034	—
PRIMARY Change From Baseline in the White Blood Cell After 20 Days of Treatment	0.008	—
PRIMARY Change From Baseline in the Bicarbonate After 20 Days of Treatment	-1.4	—
PRIMARY Change From Baseline in the Blood Urea Nitrogen After 20 Days of Treatment	1.800	—
PRIMARY Change From Baseline in the Calcium After 20 Days of Treatment	0.016	—
PRIMARY Change From Baseline in the Chloride After 20 Days of Treatment	0.8	—
PRIMARY Change From Baseline in the Creatinine After 20 Days of Treatment	1.3	—
PRIMARY Change From Baseline in the Glucose After 20 Days of Treatment	-0.19	—
PRIMARY Change From Baseline in the Potassium After 20 Days of Treatment	0.17	—
PRIMARY Change From Baseline in the Sodium After 20 Days of Treatment	0.4	—
PRIMARY Change From Baseline in the Alanine Transaminase After 20 Days of Treatment	0.6	—
PRIMARY Change From Baseline in the Albumin After 20 Days of Treatment	0.4	—
PRIMARY Change From Baseline in the Alkaline Phosphatase After 20 Days of Treatment	2.9	—
PRIMARY Change From Baseline in the Aspartate Aminotransferase After 20 Days of Treatment	1.3	—
PRIMARY Change From Baseline in the Direct Bilirubin After 20 Days of Treatment	1.0	—
PRIMARY Change From Baseline in the Total Bilirubin After 20 Days of Treatment	1.0	—
PRIMARY Change From Baseline in the C-reactive Protein After 20 Days of Treatment	-0.11	—
PRIMARY Change From Baseline in the Erythrocyte Sedimentation Rate After 20 Days of Treatment	-2.0	—
PRIMARY Assessment of the Dryness of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Oozing/Crusting of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Redness of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Scratch Marks of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Skin Thickening of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Swelling of the Area of Application	10; 0; 0; 0; 10; 0	—
PRIMARY Assessment of the Itch of the Area of Application	0.0; 0.0	—
PRIMARY Assessment of the Sleeplessness	0.0; 0.0	—

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). 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]

Eligibility Criteria

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):
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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05523011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.