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

NCT01736670 | Completed DMC

• 1 other identifier: GCO#11-0008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Steroid Responsive Dermatoses; Chronic Steroid Responsive Dermatoses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Acute Steroid Responsive dermatitis

EXPERIMENTAL

10 patients with acute steroid-responsive dermatoses

Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray

Chronic Steroid Responsive Dermatits

EXPERIMENTAL

10 patients with chronic steroid-responsive dermatoses

Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray

Control, Otherwise healthy

ACTIVE COMPARATOR

10 healthy controls

Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray

Interventions

Triamcinolone Acetonide spray DRUG

Acute Steroid Responsive dermatitis; Chronic Steroid Responsive Dermatits; Control, Otherwise healthy

Triamcinolone acetonide cream DRUG

Acute Steroid Responsive dermatitis; Chronic Steroid Responsive Dermatits; Control, Otherwise healthy

Alcohol spray DRUG

Acute Steroid Responsive dermatitis; Chronic Steroid Responsive Dermatits; Control, Otherwise healthy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Patel, Rita Vikram, M.D.: lead
• Ranbaxy Inc.: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

US (1)