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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 day 2, day 3, and day 4
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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 ~ day 2, day 3, and day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 2, day 3, and day 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in pruritus NRS on AD lesions
Secondary study objectives
Change from baseline in TAA
Change from baseline in TSS
Change from baseline in lesion IGA
+1 moreAwards & Highlights
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.
Trial 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
3,200 Total Patients Enrolled
Robert Bissonnette, MDPrincipal InvestigatorInnovaderm Research Inc.
25 Previous Clinical Trials
2,719 Total Patients Enrolled
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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.
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