Evaluating Treatment Resistant Dermatitis TaroIIR

NCT03050294 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00039302
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Investigator Global Assessment- Atopic Dermatitis

  Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease

  1 week

• Investigator Global Assessment- Psoriasis

  Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease

  2 weeks

Secondary Outcomes (6)

• Total Lesion Severity Score- Atopic Dermatitis

  1 week

• Total Lesion Severity Score-Psoriasis

  2 weeks

• Eczema Area and Severity Index- Atopic Dermatitis

  1 week

• Pruritus Visual Analog Scale- Atopic Dermatitis

  1 week

• Pruritus Visual Analog Scale- Psoriasis

  2 weeks

Study Arms (4)

Control- Atopic Dermatitis

ACTIVE COMPARATOR

Participants with atopic dermatitis will receive desoximetasone and no calls.

Drug: Desoximetasone 0.25% spray

Atopic Dermatitis Intervention

EXPERIMENTAL

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.

Behavioral: Phone calls; Drug: Desoximetasone 0.25% spray

Control- Psoriasis

ACTIVE COMPARATOR

Participants with psoriasis will receive desoximetasone and no calls.

Drug: Desoximetasone 0.25% spray

Psoriasis Intervention

EXPERIMENTAL

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.

Behavioral: Phone calls; Drug: Desoximetasone 0.25% spray

Interventions

Phone calls BEHAVIORAL

Phone calls twice daily

Atopic Dermatitis Intervention; Psoriasis Intervention

Desoximetasone 0.25% spray DRUG

Desoximetasone 0.25% spray applied twice daily

Atopic Dermatitis Intervention; Control- Atopic Dermatitis; Control- Psoriasis; Psoriasis Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Interventions

Desoximetasone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dexamethasone; Steroids, Fluorinated

Results Point of Contact

• Title: Steven R. Feldman
• Organization: Wake Forest Baptist Health

sfeldman@wakehealth.edu

336-716-7740

Study Officials

• Steve R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: February 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 20, 2020
• Results First Posted: June 15, 2018

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)