Trial Outcomes & Findings for Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis (NCT NCT03597620)
NCT ID: NCT03597620
Last Updated: 2023-12-15
Results Overview
The sPGA is the physician's global assessment of the subjects plaque psoriasis at a given time point. Plaques are assessed for induration, erythema, and scaling and an overall rating of plaque psoriasis severity is gen using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). The BSA is the amount of body surface area affected by a disease. In this, the head represents 10% of the body, the upper extremities 20%, the trunk 30%, and the lower extremities 40%. These assessments will be combined by multiplying the numerical outcomes of the sPGA and BSA assessments to form a result. The mean change in this result will then be reported as the efficacy outcome. The data was all inclusive and not divided out by arm.
COMPLETED
PHASE4
11 participants
Baseline to Week 12
2023-12-15
Participant Flow
Participant milestones
| Measure |
Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
Participants who received HAT1 treatment and were not on systemic treatment at time of enrollment
|
Systemic Therapy + Herbal Anti-Inflammatory Treatment
Participants who received HAT1 treatment and were on systemic treatment at time of enrollment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Efficacy and Tolerability of Application of Metaderm Product for the Treatment of Psoriasis
Baseline characteristics by cohort
| Measure |
Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
n=6 Participants
Participants who received HAT1 treatment and were not on systemic treatment at time of enrollment
|
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
n=5 Participants
Participants who received HAT1 treatment and were on systemic treatment at time of enrollment
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12The sPGA is the physician's global assessment of the subjects plaque psoriasis at a given time point. Plaques are assessed for induration, erythema, and scaling and an overall rating of plaque psoriasis severity is gen using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). The BSA is the amount of body surface area affected by a disease. In this, the head represents 10% of the body, the upper extremities 20%, the trunk 30%, and the lower extremities 40%. These assessments will be combined by multiplying the numerical outcomes of the sPGA and BSA assessments to form a result. The mean change in this result will then be reported as the efficacy outcome. The data was all inclusive and not divided out by arm.
Outcome measures
| Measure |
Nonsystemic Therapy+ Herbal Anti-Inflammatory Treatment (HAT1)
n=6 Participants
Participants who received HAT1 and were not on systemic treatment at time of enrollment
|
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
n=5 Participants
Participants who received HAT1 and were on systemic treatment at time of enrollment
|
|---|---|---|
|
Efficacy as Measured by the Mean Percentage Change in the Product of Static Physician Global Assessment (sPGA) and Body Surface Area (BSA).
|
53.06 percentage of change in sPGAxBSAscore
Standard Deviation 40.01
|
65.6 percentage of change in sPGAxBSAscore
Standard Deviation 19.40
|
SECONDARY outcome
Timeframe: Baseline to Week 12The dermatology quality of life index (DLQI) is a simple, subject administered, 10 question validated, quality of life questionnaire that cover 6 domains including symptoms and feelings, daily activities, leisure, work, and school, personal relationships, and treatment. Response categories include "not at all", "a lot", and "very much", with corresponding score of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." The recall period is "over the last week," totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. The data was all inclusive and not divided out by arm.
Outcome measures
| Measure |
Nonsystemic Therapy+ Herbal Anti-Inflammatory Treatment (HAT1)
n=6 Participants
Participants who received HAT1 and were not on systemic treatment at time of enrollment
|
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
n=5 Participants
Participants who received HAT1 and were on systemic treatment at time of enrollment
|
|---|---|---|
|
Efficacy as Measured by the Percentage Change in the DLQI. (Dermatology Quality of Life Index).
|
52.88 percentage change for DLQI
Standard Deviation 45.66
|
17.82 percentage change for DLQI
Standard Deviation 36.68
|
Adverse Events
Nonsystemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
Systemic Therapy + Herbal Anti-Inflammatory Treatment (HAT1)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place