An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses

This study has been completed.
Sponsor:
Collaborator:
Ranbaxy Inc.
Information provided by (Responsible Party):
Patel, Rita Vikram, M.D.
ClinicalTrials.gov Identifier:
NCT01736670
First received: November 26, 2012
Last updated: December 3, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Patel, Rita Vikram, M.D.:

Primary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736670

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Patel, Rita Vikram, M.D.
Ranbaxy Inc.
  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 October 16, 2014