Phase 4 N=24 Randomized Treatment

Evaluating Treatment Resistant Dermatitis TaroIIR

Atopic Dermatitis · Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT03050294 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2018

Primary outcome: Primary: Investigator Global Assessment- Atopic Dermatitis — 1.7; 1.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Phone calls (Behavioral); Desoximetasone 0.25% spray (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Investigator Global Assessment- Atopic Dermatitis	1.7; 1.5	—
PRIMARY Investigator Global Assessment- Psoriasis	2.5; 2.3	—
SECONDARY Total Lesion Severity Score- Atopic Dermatitis	3.8; 4.7	—
SECONDARY Total Lesion Severity Score-Psoriasis	6.5; 5.8	—
SECONDARY Eczema Area and Severity Index- Atopic Dermatitis	3.1; 1.2	—
SECONDARY Pruritus Visual Analog Scale- Atopic Dermatitis	1.1; 1.2	—
SECONDARY Pruritus Visual Analog Scale- Psoriasis	1.4; 1.3	—
SECONDARY Psoriasis Area and Severity Index	7.1; 5.1	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03050294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.