Plaque Psoriasis
Conditions
Brief summary
The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.
Interventions
DRUGClobex Spray
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years of age or older. * Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray. * Subjects with a target lesion of at least 1 cm x 1 cm * Subjects who agree to be photographed at each visit
Exclusion criteria
* Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study. * Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink. * Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial. * Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee. * Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Target Lesion Severity Score. | 2 weeks | Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Reported Target Lesion Severity Score | 2 weeks | Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clobex Spray Clobex Spray | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Clobex Spray |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 4 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Subject Reported Target Lesion Severity Score.
Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobex Spray | Subject Reported Target Lesion Severity Score. | 4.0 units on a scale | Standard Deviation 2.5 |
Secondary
Investigator Reported Target Lesion Severity Score
Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clobex Spray | Investigator Reported Target Lesion Severity Score | 3.3 units on a scale | Standard Deviation 2.1 |