Plaque Psoriasis
Conditions
Brief summary
To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis
Interventions
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed IRB approved written informed consent/assent 2. 12 to 75 years of age, inclusive. 3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis. 4. Baseline Investigator's Global Assessment Score of 3 (moderate). 5. Subjects must have a Body Surface Area (BSA) between 2% to 20% 6. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
Exclusion criteria
1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. 2. Current diagnosis of unstable forms of psoriasis in the treatment area. 3. History of unresponsiveness to topical treatment for psoriasis 4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations 5. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments 6. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study 7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. 8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) | Day 1 to Day 56 | percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1 |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 98 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 129 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 169 | 0 / 166 | 0 / 81 |
| other Total, other adverse events | 0 / 169 | 0 / 166 | 0 / 81 |
| serious Total, serious adverse events | 0 / 169 | 0 / 166 | 0 / 81 |
Outcome results
None listed