An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
NCT ID: NCT01736670
Last Updated: 2012-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-04-30
Brief Summary
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In contrast to creams and ointments, T Spray can easily cover large and hard-to-reach areas of the body. Its optional nozzle directs application of the medication to precise areas without affecting nearby areas. Patients requiring a mid-potency corticosteroid for lesions on the scalp, back, intertriginous folds, large areas, or areas that require precise application would benefit from the T Spray formulation. In the time since the introduction of T Spray to dermatology, other topical corticosteroids have entered the market, but T Spray remains the only mid-potency corticosteroid available in a spray formulation.
In a recently published open-label, non-comparator study involving 42 patients with chronic steroid-responsive dermatoses, T Spray was used up to four times a day for 28 days. Improvement of lesions after one week of treatment was experienced by 85% of patients, and 95% of subjects preferred the spray over creams and ointment. Most importantly, 56% of patients reported an anti-pruritic cooling effect which was experienced upon application.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Acute Steroid Responsive dermatitis
10 patients with acute steroid-responsive dermatoses
Triamcinolone Acetonide spray
Triamcinolone acetonide cream
Alcohol spray
Chronic Steroid Responsive Dermatits
10 patients with chronic steroid-responsive dermatoses
Triamcinolone Acetonide spray
Triamcinolone acetonide cream
Alcohol spray
Control, Otherwise healthy
10 healthy controls
Triamcinolone Acetonide spray
Triamcinolone acetonide cream
Alcohol spray
Interventions
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Triamcinolone Acetonide spray
Triamcinolone acetonide cream
Alcohol spray
Eligibility Criteria
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Inclusion Criteria
2. A clear diagnosis of the chronic steroid-responsive dermatosis (i.e. psoriasis, atopic dermatitis) or acute steroid-responsive dermatosis (i.e. contact dermatitis, first-degree burn) must have been previously established and patients must have a target lesion that can be assessed for severity of inflammation
3. Females of childbearing potential must have a negative urine pregnancy test to participate in the study
4. Subjects must be able to understand the requirements of the study and sign an informed consent prior to study procedures
Exclusion Criteria
2. Subjects with a known hypersensitivity to any component of the T Spray
3. Subjects who are using any medication or have a disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study
4. Subjects with any of the following pathologies: cold urticaria, cryoglobulinemia, Raynaud's phenomena, or Paroxysmal cold hemoglobulinuria
18 Years
85 Years
ALL
Yes
Sponsors
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Ranbaxy Inc.
INDUSTRY
Patel, Rita Vikram, M.D.
INDIV
Responsible Party
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Locations
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Mount Sinai School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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GCO#11-0008
Identifier Type: -
Identifier Source: org_study_id