An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
Completed · Not applicable
Conditions studied: Acute Steroid Responsive Dermatoses, Chronic Steroid Responsive Dermatoses
In brief
Triamcinolone acetonide is a mid-potency, class 4/5 topical corticosteroid that is available in a spray formulation (Triamcinolone Acetonide Spray, T Spray). It is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Unlike more potent steroid products, T Spray has no time limitations on its use; therefore, it is commonly used to treat flares in psoriasis, atopic dermatitis, seborrheic dermatitis, and contact dermatitis. 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.
Key facts
- Study ID
- NCT01736670
- Run by
- Patel, Rita Vikram, M.D.
- People needed
- 30
- Starts
- 2012-04-01
- Last updated by the study team
- 2012-12-04
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must be at least 18 years old and in good general health, as confirmed by a medical history
- 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
- Females of childbearing potential must have a negative urine pregnancy test to participate in the study
- Subjects must be able to understand the requirements of the study and sign an informed consent prior to study procedures
You may not qualify if…
- Subjects who are pregnant and/or nursing
- Subjects with a known hypersensitivity to any component of the T Spray
- 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
- Subjects with any of the following pathologies: cold urticaria, cryoglobulinemia, Raynaud's phenomena, or Paroxysmal cold hemoglobulinuria
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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