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Phase 4 Completed N=24 Randomized Treatment

Evaluating Treatment Resistant Dermatitis TaroIIR

Source: ClinicalTrials.gov NCT03050294 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Investigator Global Assessment- Atopic Dermatitis — 1.7; 1.5 units on a scale
◆ Published Evidence
No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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