Conditions: Atopic Dermatitis Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief summary:
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. The development of resistance to treatment is termed tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.

Detailed description:
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. Prolonged treatment with corticosteroids occasionally results in resistance to treatment. The development of resistance to treatment is termed tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of target receptors, resulting is a decreased metabolic effect of the compound.

Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. Patients' use of topical medications decrease over time. Topical spray vehicles have become increasingly more popular because of their rapid application and ease of use. Desoximetasone 0.25% spray is a well-tolerated, FDA approved, potent topical corticosteroid that rapidly and successfully treats inflammatory skin diseases.

Lots of treatment options exist for psoriasis; however, some patients do not get better using these medications. These patients are said to have resistant disease. In this study, we define resistant disease by failure of previous topical steroid treatment. Poor adherence is a barrier to positive clinical outcomes. Failure to respond to medication may be a result of poor adherence rather than resistance to the topical therapy. The purpose of this study is to delineate between the two.

The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.

We propose to enroll 12 subjects with psoriasis and 12 subjects with atopic dermatitis who have "failed" previous topical treatment. Subjects will be required to have body surface area involvement that can be reasonably treated with topical treatment. At the baseline visit, patients will be given Topicort spray and will be shown how to use it. Patients will apply the medication at the initial visit under supervision. Subjects with atopic dermatitis will be treated for 1 week; subjects with psoriasis will be treated for 2 weeks. Visits will take place at baseline, 3 days, 1 week, and in the case of psoriasis, 2 weeks. All subjects enrolled in the study will receive nominal compensation per visit.

To assure good adherence to treatment, patients will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. Disease severity will be measured by EASI (atopic dermatitis)/PASI (psoriasis), Investigator Global Assessment (IGA), and Pruritus Visual Analog Scale (Pruritus VAS). Based on our previous experience, we expect rapid improvement in disease severity measures with good adherence to short term use of highly effective topical treatment. Mean and median changes in the efficacy measures will be reported. In the primary analyses, Wilcoxon signed rank tests will be used to analyze improvements in assessments at end of study compared to baseline.

Arms:
arm 1: Participants with atopic dermatitis will receive desoximetasone and no calls. arm 2: Participants with atopic dermatitis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication. arm 3: Participants with psoriasis will receive desoximetasone and no calls. arm 4: Participants with psoriasis will receive desoximetasone and will be called twice each day, morning and evening, at predetermined times to go over their use of the medication.

Interventions: intervention 1: Phone calls intervention 2: Desoximetasone 0.25% spray
Intervention descriptions: intervention 1: Phone calls twice daily intervention 2: Desoximetasone 0.25% spray applied twice daily

Protocol document:
Prot_SAP_000.pdf: 
TaroIIR-SRF04 Protocol version:1.0 (11/16)  
1 
 
 
 
 
 
 
 
 
 
 
 
Evaluating treatment resistant dermatitis 
 
NCT03050294 
 
5/23/18


TaroIIR-SRF04 Protocol version:1.0 (11/16)  
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Evaluating treatment resistant dermatitisStudy Title: Evaluating treatment resistant dermatitis 
 
Principal Investigator, Co-investigator(s): Steven R. Feldman, M.D., Ph.D. 
 
Sponsor or funding source: Taro Pharmaceuticals U.S.A., Inc. 
 
Background, Rationale and Context 
Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of 
patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment 
of both these conditions, especially when they are localized rather than wide spread. Prolonged treatment 
with corticosteroids occasionally results in resistance to treatment. The development of resistance to 
treatment is termed tachyphylaxis. Tachyphylaxis has been thought to be a result of down regulation of 
target receptors, resulting is a decreased metabolic effect of the compound.  
 
Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to 
topical corticosteroids. Patients’ use of topical medications decrease over time.  The messiness of 
ointment and other topical preparations are a hurdle to good adherence. Topical spray vehicles have 
become increasingly more popular because of their rapid application and ease of use. Desoximetasone 
0.25% spray is a well-tolerated, potent topical corticosteroid that rapidly and successfully treats 
inflammatory skin diseases.1  
 
Lots of treatment options exist for psoriasis; however, some patients do not get better using these 
medications. These patients are said to have resistant disease. In this study, we define resistant disease by 
failure of previous topical steroid treatment.  Poor adherence is a barrier to positive clinical outcomes. 
Failure to respond to medication may be a result of poor adherence rather than resistance to the topical 
therapy. The purpose of this study is to delineate between the two. 
 
 
Objectives 
The primary objective of the study is to determine, under conditions designed to assure good adherence, 
whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant 
inflammatory skin disease defined by failure of previous topical steroid treatment. 
 
 
Methods and Measures 
 
Design 
 
This is an opened label, randomized, single centered clinical study. Subjects with atopic dermatitis and 
psoriasis, whom previously failed adequate topical corticosteroid therapy, will be recruited, including 
subjects who may have been prescribed Topicort in the past with no response.  Twenty-four subjects will 
be enrolled; 12 subjects with psoriasis and 12 with atopic dermatitis, with disease that is amenable to 
topical therapy. Screening data will be reviewed to determine subject eligibility.  Subjects who meet all 
inclusion and exclusion criteria be offered enrollment into the study. At the baseline visit  subjects will be 
randomized to either receive twice a day phone calls to discuss their medication use or no call, standard of 
care, for the one or two weeks they are in the research study. 
 
Subjects with atopic dermatitis will be treated for 1 week; subjects with psoriasis will be treated for 2 
weeks with topical 0.25% desoximetasone spray.   Each visit, disease severity will be measured by  Total 
Lesion Severity Score (TLSS), Eczema Area and Severity Index/Psoriasis Body surface area (EASI) and 


TaroIIR-SRF04 Protocol version:1.0 (11/16)  
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(PASI) scoring. Investigator Global Assessment Score (IGA) and Pruritus Visual Analog Scale (VAS) 
will be determined for both diseases. Visits will take place at baseline, 3 days, 1 week, and in the case of 
psoriasis, 2 weeks. We will complete a chart review to determine and/or contact each patient via phone to 
determine which topical medications they were considered resistant to prior to completing the study. 
 
Subjects selection criteria 
Subjects with a diagnosis of plaque-type psoriasis or atopic dermatitis who meet the inclusion and 
exclusion criteria will be eligible for participation in this study. Safety and effectiveness of Topicort 
Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric 
patients is not recommended. Patients will be recruited in the dermatology clinic during their regular 
clinic visit. In clinic, if the patient is eligible for the study they will be asked whether they would be 
interested in the research study. If they reply yes, further information will be given about the research 
study. At this time if the patient still agrees to participate, after the patient is complete with checkout they 
will be taken to the clinical studies research center, located upstairs from the dermatology  clinic to read 
the research study consent form. A study team member will answer any questions they may have about 
the research study. Once the patient has signed the consent, we will begin the baseline/screening 
evaluation. 
 
Inclusion Criteria 
Male or female ≥18 years of age at baseline visit. 
 
Documentation of plaque-type psoriasis or atopic dermatitis diagnosis as evidenced by one or 
more clinical features  
 
Written informed consent (and assent when applicable) obtained from subject or subject’s legal 
representative and ability for subject to comply with the requirements of the study 
 
Exclusion Criteria 
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 
 
Presence of a condition or abnormality that in the opinion of the Investigator would compromise 
the safety of the patient or the quality of the data. 
 
No access to a phone throughout the day 
 
Subject is diagnosed with a disease that is known to effect adherence and would otherwise bias 
our results (Such as Alzheimer’s or dementia) 
 
Patient had a history of allergy or sensitivity to corticosteroids or history of any drug 
hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the 
safety of the patient or the results of the study. 
 
Interventions and Interactions 
All study subjects will be treated with Topicort (desoximetasone spray 0.25%), an FDA 
approved drug for the treatment of plaque-type psoriasis.2 Topicort 100mL sprays will be 
provided to the subjects, at no cost to the subject, throughout the study. 
Supply of Study Drug at the Site 
The Sponsor will ship Study Drug to the investigational site.  The initial study drug shipment will be 
shipped after site activation (i.e., all required regulatory documentation has been received by the Sponsor 


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and a contract has been executed). Subsequent study drug shipments will be made after site request for 
resupply. 
Dosage/Dosage Regimen 
Study subjects will be provided with one 100 ml bottle of study medication along with 
instructions for dosing. Subjects will be asked to apply the drug twice daily on effected sites. 
Each application is approximately 0.5mL of solution.2 
Storage 
Study drug should be stored by the study site at controlled room temperature, 15 to 30ºC (59 to 
86ºF). If the temperature of study drug storage in the clinic/pharmacy exceeds or falls below this 
range, this should be reported to the Sponsor or designee and captured as a deviation. Subjects will 
be instructed to store the medication in original packaging at room temperature according to the 
instructions outlined on the Drug Administration Instructions.2 
Study Drug Accountability 
An accurate and current accounting of the dispensing and return of study drug for each subject 
will be maintained on an ongoing basis by a member of the study site staff.  
Clinical Assessments 
Concomitant Medications 
All concomitant medication and concurrent therapies will be documented at every visit, including 
baseline. Dose, route, unit frequency of administration, and indication for administration and dates of 
medication will be captured. 
Demographics  
Demographic information (date of birth, gender, race) will be recorded at Screening. 
Medical History  
Relevant medical history, including history of current disease, other pertinent respiratory history, and 
information regarding underlying diseases will be recorded at Screening. 
Physical Examination 
A physical examination will be performed by qualified  health professional at the baseline visit. Qualified 
staff (MD, NP, RN, and PA) may complete the abbreviated physical exam at all other visits.  New 
abnormal physical exam findings must be documented and will be followed by a physician or other 
qualified staff at the next scheduled visit. 


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Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the study. Duration (start 
and stop dates), severity/grade, outcome, treatment and relation to study drug will be recorded on the case 
report form (CRF). 
Clinical Laboratory Measurements 
Pregnancy Test 
A urine  pregnancy test will be obtained from female subjects who are of childbearing age prior to their 
participation in the study. 
EVALUATIONS BY VISIT 
Visit 1 (Baseline/Screening) 
1. Review the study with the subject (subject’s legal representative) and obtain written informed 
consent. 
2. Assign the subject a unique screening number. 
3. Record demographics data. 
4. Record medical history, including smoking and alcohol use. 
5. Record concomitant medications. 
6. Perform a physical examination of the skin, which includes measuring and recording 
modified Eczema Area and Severity Index/Psoriasis Body surface area (EASI/PASI), Total 
Lesion Severity Score (TLSS), Investigator Global Assessment Score (IGA), and Pruritus 
Visual Analog Scale (VAS). 
7. Perform and record vital signs. 
8. Perform and record urinary test (for female subjects). 
9. Schedule subject for Visit 2 in 3 days. 
10. Dispense study drug with instructions on use and under supervision the patient will apply the 
medication 
Visit 2 (Day 3) 
1. Record any Adverse Experiences  
2. Concomitant medications review. 
3. Perform abbreviated physical examination, which includes measuring and recording subjects 
TLSS, EASI/PASI, IGA, and Pruritus VAS. 
Visit 3 (Week 1) 
1. Record any Adverse Experiences  
2. Concomitant medications review. 
3. Perform abbreviated physical examination, which includes measuring and recording subjects 
TLSS, EASI/PASI, IGA, and Pruritus VAS. 
Visit 4 (Week 2) 
1. Record any Adverse Experiences  
2. Concomitant medications review. 


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3. Perform abbreviated physical examination, which includes measuring and recording subjects 
TLSS, EASI/PASI, IGA, and Pruritus VAS. 
 
Outcome Measure(s) 
The primary efficacy endpoint is the change in IGA, TLSS, from baseline.  Other measures will include, 
EASI or PASI (for atopic dermatitis and psoriasis, respectively), target lesions severity score (TLSS), and 
Pruritus VAS scores from baseline 
 
Analytical Plan 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.  
Regression analysis will be performed to identify independent outcome predictors.  Other inferential 
statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Subjects with a diagnosis of plaque-type psoriasis or atopic dermatitis who meet the inclusion and 
exclusion criteria will be eligible for participation in this study. Patients will be recruited via phone or in 
the dermatology clinic by staff members that are included in the IRB protocol. If recruited via phone, 
subjects will be invited to make an appointment for baseline visit. During the baseline visit, formal 
informed consent will be obtained. In clinic, if the patient is eligible for the study they will first be asked 
whether they would be interested in joining a research study pertaining to their plaque-type psoriasis or 
atopic dermatitis. If they reply yes, they will be given more information about the research study. If the 
patient agrees to participate, after the patient is complete with checkout they will be taken to the clinical 
studies research center. Women and minorities will be included. Women of childbearing potential will 
have to agree to practice birth control during their participation in the study. All recruitment conversations 
will take place over the phone, in an exam room, either in the clinic or the research center in order to 
maintain privacy and confidentiality.  
 
 
Informed Consent 
 
Signed informed consent will be obtained from each subject. A study team member will obtain informed 
consent from the subject in the exam room in the clinical studies research center. 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form.  Any collected 
patient identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, store separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Following data collection subject identifying information will be destroyed 
(state the anticipated time the data will be destroyed, e.g. three years after closure of the study, and the 
method of destruction), consistent with data validation and study design, producing an anonymous 
analytical data set.  Data access will be limited to study staff.  Data and records will be kept locked and 
secured, with any computer data password protected.  No reference to any individual participant will 
appear in reports, presentations, or publications that may arise from the study. 
 


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Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. 
 
 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will 
be promptly reported by the principal investigator or designated member of the research team to the IRB 
and sponsor or appropriate government agency if appropriate. 
 
Early Discontinuation of Study Drug  
A subject may be discontinued from study treatment at any time if the subject, the investigator, sub-
investigator, or staff that are approved by the IRB, or the Sponsor feels that it is not in the subject’s best 
interest to continue.  The following is a list of possible reasons for study treatment discontinuation:  
• 
Subject withdrawal of consent (or assent) 
• 
Subject is not compliant with study procedures 
• 
Adverse event that in the opinion of the investigator, sub-investigator, or staff that are approved by 
the IRB would be in the best interest of the subject to discontinue study treatment 
• 
Protocol violation requiring discontinuation of study treatment 
• 
Lost to follow-up 
• 
Sponsor request for early termination of study 
• 
Positive pregnancy test (females) 
 
If a subject is withdrawn from treatment due to an adverse event, the subject will be followed and treated 
by the research study team until the abnormal parameter or symptom has resolved or stabilized.   
 
All subjects who discontinue study treatment should come in for an early discontinuation visit as soon as 
possible and then should be encouraged to complete all remaining scheduled visits and procedures. 
 
All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, 
and without prejudice. 
 
Reasonable attempts will be made by the staff to provide a reason for subject withdrawals.  The reason for 
the subject’s withdrawal from the study will be specified in the subject’s source documents. 


TaroIIR-SRF04 Protocol version:1.0 (11/16)  
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References: 
1. Data on file. Taro Pharmaceuticals U.S.A., Inc.  
2. Topicort® Topical Spray Prescribing Information.Taro Pharmaceuticals U.S.A., Inc 
 
 
 
 
 
 
 
 
 
 


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