Trial Outcomes & Findings for Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT (NCT NCT04510675)
NCT ID: NCT04510675
Last Updated: 2023-05-17
Results Overview
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
24, 48, 72, and 96 Hours
Results posted on
2023-05-17
Participant Flow
Participant milestones
| Measure |
Test Article (Omeza Collagen Matrix) and Negative Control (Occlusive Patch of 0.9% NaCl)
Each subject will be treated with the test article (Omeza Collagen Matrix) and the negative control (Occlusive Patch of 0.9% sodium chloride, NaCl) at the same time.
During an induction phase of the study, the test article and negative control will be applied repetitively and continuously on one side of the paraspinal region of the back. Each application will be for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. The application sites of subject will be evaluated using the Skin Irritation Scale at approximately 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the test article and negative control.
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Test Article (Omeza Collagen Matrix) and Negative Control (Occlusive Patch of 0.9% NaCl)
Each subject will be treated with the test article (Omeza Collagen Matrix) and the negative control (Occlusive Patch of 0.9% sodium chloride, NaCl) at the same time.
During an induction phase of the study, the test article and negative control will be applied repetitively and continuously on one side of the paraspinal region of the back. Each application will be for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. The application sites of subject will be evaluated using the Skin Irritation Scale at approximately 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the test article and negative control.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Irritation Potential of Omeza Collagen Matrix Using Modified HRIPT
Baseline characteristics by cohort
| Measure |
Test Article and Control
n=58 Participants
Each subject will receive all investigational products at the same time.
Test Article: Omeza Collagen Matrix
Negative Control: Occlusive Patch of 0.9% sodium chloride, NaCl
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24, 48, 72, and 96 HoursPopulation: 58 subjects were enrolled with 53 subjects completing the study.
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
Outcome measures
| Measure |
Test Article (Omeza Collagen Matrix)
n=53 Participants
Repetitive and continuous patch applications of the test article (Omeza Collagen Matrix) to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications.
|
Negative Control (0.9% Aqueous Sodium Chloride)
n=53 Participants
Repetitive and continuous patch applications of the negative control (0.9% aqueous sodium chloride) to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications.
|
|---|---|---|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 0 at 24 Hours
|
53 Participants
|
49 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score + at 24 Hours
|
0 Participants
|
4 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 1 at 24 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 0 at 48 Hours
|
52 Participants
|
50 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score + at 48 Hours
|
1 Participants
|
3 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 1 at 48 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 2 at 48 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 3 at 48 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 0 at 72 Hours
|
53 Participants
|
50 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score + at 72 Hours
|
0 Participants
|
3 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 3 at 96 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 2 at 24 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 3 at 24 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 1 at 72 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 2 at 72 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 3 at 72 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 0 at 96 Hours
|
53 Participants
|
53 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score + at 96 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 1 at 96 Hours
|
0 Participants
|
0 Participants
|
|
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Frequency of Irritation Score 2 at 96 Hours
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: While only 53 subjects completed the study, a total of 58 subjects were enrolled. Therefore, adverse events were assessed in relation to the entire 58 patients who were enrolled.
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.
Outcome measures
| Measure |
Test Article (Omeza Collagen Matrix)
n=58 Participants
Repetitive and continuous patch applications of the test article (Omeza Collagen Matrix) to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications.
|
Negative Control (0.9% Aqueous Sodium Chloride)
n=58 Participants
Repetitive and continuous patch applications of the negative control (0.9% aqueous sodium chloride) to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications.
|
|---|---|---|
|
Adverse Events Deemed Related to the Test Product or the Study
|
0 Adverse Events
|
0 Adverse Events
|
Adverse Events
Test Article (Omeza Collagen Matrix) and Negative Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Article (Omeza Collagen Matrix) and Negative Control
n=58 participants at risk
Each subject was treated with the test article (Omeza Collagen Matrix) and the negative control (Occlusive Patch of 0.9% sodium chloride, NaCl) at the same time.
During an induction phase of the study, the test article and negative control was applied repetitively and continuously on one side of the paraspinal region of the back. Each application was for approximately 48 hours (weekdays) or 72 hours (weekends) over three weeks for a total of 9 applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control were applied for 48 hours. The application sites of subject were evaluated using the Skin Irritation Scale at approximately 30 minutes, 24 hours, 48 hours, and 72 hours after removal of the test article and negative control.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.7%
1/58 • Number of events 1 • Adverse events were monitored throughout the study with each patient monitored over the 6 weeks of treatment.
Since both the test article and negative control were administered at the same time, it would not be possible to determine if any systemic adverse events were related to the test article or the negative control. As such, the arms are combined for the adverse event record.
|
Additional Information
Principal Investigator
Princeton Consumer Research Corp.
Phone: 727-576-7300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place