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Corticosteroid
Steroid Cream for Eczema
Phase 4
Recruiting
Led By Robert Bissonnette, MD
Research Sponsored by Innovaderm Research Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, 36, 48, and 60 hours
Awards & highlights
Study Summary
This trial tests a steroid cream for eczema to see if it helps reduce symptoms.
Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of active atopic dermatitis (AD), based on specific criteria. They must have stable AD without significant flares for the last 4 weeks and two areas of skin affected. Excluded are those with immune deficiencies, chronic infections, allergies to the study drug, pregnant or breastfeeding women, certain skin types, other interfering skin conditions or cancer within the past 5 years.Check my eligibility
What is being tested?
The trial tests Triamcinolone Acetonide (Aristocort® C) against a placebo ('Vehicle') in subjects with atopic dermatitis. It's designed as an intraindividual study where each subject receives both treatments on different parts of their body to compare effectiveness directly.See study design
What are the potential side effects?
While not specified here, common side effects of topical steroids like Triamcinolone may include burning, itching, irritation at the application site; dryness; changes in skin color; acne; and rarely more serious systemic effects if absorbed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12, 24, 36, 48, and 60 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, 36, 48, and 60 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change from baseline in TAA
Change from baseline in TSS
Change from baseline in lesion IGA
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Triamcinolone Acetonide (Aristocort® C)Active Control1 Intervention
Group II: VehiclePlacebo Group1 Intervention
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Who is running the clinical trial?
Innovaderm Research Inc.Lead Sponsor
48 Previous Clinical Trials
3,196 Total Patients Enrolled
Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.
25 Previous Clinical Trials
2,715 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have a weakened immune system.I have a long-term infectious disease.I am allergic to triamcinolone acetonide or components of the study drug.Your skin type is very dark.I am currently breastfeeding, pregnant, or planning to become pregnant during the study.I have a skin condition that could affect the study's results, besides atopic dermatitis.I have been diagnosed with active atopic dermatitis.I have had atopic dermatitis for over 6 months with no severe flare-ups in the last 4 weeks.I have two skin areas, each at least 6cm by 6cm, suitable for treatment.I have had cancer or a related disease in the last 5 years.I have a skin infection due to atopic dermatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Triamcinolone Acetonide (Aristocort® C)
- Group 2: Vehicle
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted any clearance to Triamcinolone Acetonide (Aristocort® C)?
"The safety of Triamcinolone Acetonide (Aristocort® C) earned a score of 3 due to its Phase 4 rating, indicating that the drug has been approved by regulatory bodies."
Answered by AI
Are there any vacancies left in this medical trial?
"The information available on clinicaltrials.gov reveals that this experiment is currently in search of participants, with the original post date being May 1st 2023 and a recent update occurring on April 25th 2023."
Answered by AI
How many participants are currently enrolled in this research trial?
"That is correct. According to the data on clinicaltrials.gov, this trial has been actively recruiting since May 1st 2023 and was most recently updated April 25th 2023. The study requires enrollment of only twenty individuals at a single medical centre."
Answered by AI
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