Acute Steroid Responsive DermatosesNCT01736670
An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
A study testing Triamcinolone Acetonide spray, Triamcinolone acetonide cream and Alcohol spray in people with Acute Steroid Responsive Dermatoses and Chronic Steroid Responsive Dermatoses, run by Patel, Rita Vikram, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Steroid Responsive Dermatoses, Chronic Steroid Responsive Dermatoses
- What is being tested?
- Triamcinolone Acetonide spray, Triamcinolone acetonide cream and Alcohol spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
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.
- Being tested
- Triamcinolone Acetonide spray, Triamcinolone acetonide cream, Alcohol spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide sprayDrug
Triamcinolone acetonide creamDrug
Alcohol sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| Acute Steroid Responsive dermatitis | Experimental | 10 patients with acute steroid-responsive dermatoses Receives: Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray |
| Chronic Steroid Responsive Dermatits | Experimental | 10 patients with chronic steroid-responsive dermatoses Receives: Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray |
| Control, Otherwise healthy | Active comparator | 10 healthy controls Receives: Drug: Triamcinolone Acetonide spray; Drug: Triamcinolone acetonide cream; Drug: Alcohol spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Steroid Responsive DermatosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patel, Rita Vikram, M.D.
- Collaborators
- Ranbaxy Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736670
- Sponsor's protocol ID
- GCO#11-0008
- Status last verified
- Dec 2012
- First submitted
- 26 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Study to Assess the Cooling Effect of Triamcinolone Acetonide Aerosol When Used for Steroid-Responsive Dermatoses
- ClinicalTrials.gov ID
- NCT01736670
- Acronym / sponsor ID
- GCO#11-0008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Patel, Rita Vikram, M.D.
- Collaborators
- Ranbaxy Inc.
- Study start
- Apr 2012
- Primary completion
- May 2012 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Steroid Responsive dermatitis | Experimental | Drug: Triamcinolone Acetonide spray, Drug: Triamcinolone acetonide cream, Drug: Alcohol spray10 patients with acute steroid-responsive dermatoses |
| Chronic Steroid Responsive Dermatits | Experimental | Drug: Triamcinolone Acetonide spray, Drug: Triamcinolone acetonide cream, Drug: Alcohol spray10 patients with chronic steroid-responsive dermatoses |
| Control, Otherwise healthy | Active comparator | Drug: Triamcinolone Acetonide spray, Drug: Triamcinolone acetonide cream, Drug: Alcohol spray10 healthy controls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Skin Surface Temperature Change
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide spray, Triamcinolone acetonide cream and Alcohol spray in people with Acute Steroid Responsive Dermatoses and Chronic Steroid Responsive Dermatoses, run by Patel, Rita Vikram, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Surface Temperature Change (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.