Psoriasis
Conditions
Keywords
Plaque psoriasis
Brief summary
The objective of this study is to evaluate the potential of desoximetasone 0.25% topical spray to suppress HPA axis function. The potential for adrenal suppression will be assessed following multiple dosing with Desoximetasone 0.25% Topical Spray in patients with moderate to severe plaque psoriasis. The secondary objectives are to evaluate the efficacy parameters and to evaluate the adverse event (AE) profile.
Interventions
Desoximetasone spray applied to affected areas twice daily for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a definite clinical diagnosis of stable plaque psoriasis with the extent of BSA affected as designated for each group * Group 1: involvement of 10-15% of their BSA * Group 2: involvement of \> 15% of their BSA * Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. * Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of these stipulations:
Exclusion criteria
* Female who is pregnant, nursing, planning to become pregnant during the duration of the study, or if of child bearing potential and sexually active not prepared to use appropriate contraceptive methods to avoid pregnancy. * Patient has current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind on the face or scalp that will require active treatment during the study. * Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. * In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis * Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study. * Patient has a history of an adverse reaction to CortrosynTM or similar test reagents. * Patient has a significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation in the study. * Patient is currently receiving or has received any radiation therapy, anti-neoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug. * Patient has undergone treatment with any systemic or photo antipsoriatic therapy within 8 weeks of the first dose of study drug. * Patient has been treated within 12 weeks (or five half lives whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. * Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. * Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression | 28 days | Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis | 28 days | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the Rule of Nine was be used |
| Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis | 28 days | The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psoriasis Involving 10-15% BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days | 12 |
| Psoriasis Involving >15% of BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area.
Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Psoriasis Involving 10-15% BSA | Psoriasis Involving >15% of BSA | Total |
|---|---|---|---|
| Age, Continuous | 52.08 years FULL_RANGE 3.55 | 46.75 years FULL_RANGE 5.99 | 49.42 years FULL_RANGE 4.77 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression
Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Psoriasis Involving 10-15% BSA | Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression | 2 participants | 3.55 |
| Psoriasis Involving >15% of BSA | Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression | 3 participants | 5.99 |
95% CI: [0.055, 11.126]
Secondary
Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis
Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the Rule of Nine was be used
Time frame: 28 days
Population: No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis.~As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Involving 10-15% BSA | Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis | 5.50 percentage of Body Surface Area Affected | Standard Deviation 3.55 |
| Psoriasis Involving >15% of BSA | Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis | 3.50 percentage of Body Surface Area Affected | Standard Deviation 5.99 |
Secondary
Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis
The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).
Time frame: 28 days
Population: No statistical analysis provided for Percentage of Participants With a Physician's Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psoriasis Involving 10-15% BSA | Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis | 1.83 percentage of physician's global assessm | Standard Deviation 0.94 |
| Psoriasis Involving >15% of BSA | Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis | 1.33 percentage of physician's global assessm | Standard Deviation 1.15 |