An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Steroid Responsive Dermatoses Chronic Steroid Responsive Dermatoses |
Drug: Triamcinolone Acetonide spray Drug: Triamcinolone acetonide cream Drug: Alcohol spray |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses |
- Skin Surface Temperature Change [ Time Frame: 1 month ] [ Designated as safety issue: No ]By using an infrared video camera, to assess whether Triamcinolone Acetonide Spray's (T Spray) reduces in skin surface temperature (SST) when applied as indicated, for a two-second spray interval, to either acute or chronic steroid-responsive dermatoses
| Enrollment: | 30 |
| Study Start Date: | April 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Acute Steroid Responsive dermatitis
10 patients with acute steroid-responsive dermatoses
|
Drug: Triamcinolone Acetonide spray Drug: Triamcinolone acetonide cream Drug: Alcohol spray |
|
Experimental: Chronic Steroid Responsive Dermatits
10 patients with chronic steroid-responsive dermatoses
|
Drug: Triamcinolone Acetonide spray Drug: Triamcinolone acetonide cream Drug: Alcohol spray |
|
Active Comparator: Control, Otherwise healthy
10 healthy controls
|
Drug: Triamcinolone Acetonide spray Drug: Triamcinolone acetonide cream Drug: Alcohol spray |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Patel, Rita Vikram, M.D. |
| ClinicalTrials.gov Identifier: | NCT01736670 History of Changes |
| Other Study ID Numbers: | GCO#11-0008 |
| Study First Received: | November 26, 2012 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Skin Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013