Acute Steroid Responsive Dermatoses Clinical Trial
Official title:
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
| NCT number | NCT01736670 |
| Other study ID # | GCO#11-0008 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | November 26, 2012 |
| Last updated | December 3, 2012 |
| Start date | April 2012 |
| Verified date | December 2012 |
| Source | Patel, Rita Vikram, M.D. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: 1. Subjects must be at least 18 years old and in good general health, as confirmed by a medical history 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: 1. Subjects who are pregnant and/or nursing 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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Mount Sinai School of Medicine | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Patel, Rita Vikram, M.D. | Ranbaxy Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Skin Surface Temperature Change | 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 | 1 month | No |