Back to resultsShort-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Triamcinolone Acetonide (Aristocort® C)
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, aristocort, triamcinolone acetonide
Eligibility Criteria
Inclusion Criteria: Male or female subjects 18 years of age or older at the time of consent. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria. Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening. Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1. Exclusion Criteria: Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. Subject has clinically infected AD. Subject has a Fitzpatrick's Skin Phototype ≥5. Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator. Subject is known to have immune deficiency or is immunocompromised. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results. Subject has a known history of chronic infectious disease. Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.
Sites / Locations
- Innovaderm Research Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Triamcinolone Acetonide (Aristocort® C)
Vehicle
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in pruritus NRS on AD lesions
The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
Secondary Outcome Measures
Change from baseline in pruritus NRS on AD lesions
The intensity of pruritus will be evaluated using a NRS (Numeric Rating Scale) by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
Change from baseline in skin biomarkers for AD
An untargeted biomarker approach with gene expression profile of treated and untreated skin samples will be performed.
Change from baseline in TSS
The TSS (Total Sign Score) is an assessment of the severity of erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness, each scored independently using the 4-point severity scale with a value range from 0 to 3 (clear to severe). The rating for each parameter is then summed to create a score ranging from 0 to 18.
Change from baseline in TAA
The TAA (Target Areas Assessment) is a 6-point scale with a value range from 0 to 5 (clear to very severe) used to evaluate AD severity at each site of study drugs application.
Change from baseline in lesion IGA
The lesion IGA (Investigator Global Assessment) is a 5-point scale with a value range from 0 to 4 (clear to severe) used for the assessment of each target lesion severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05844618
Brief Title
Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
Official Title
A Randomized, Intraindividual, Phase 4 Study to Evaluate the Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovaderm Research Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.
Detailed Description
This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis.
Approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle in two different randomized areas for 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, aristocort, triamcinolone acetonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Intra-individual
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone Acetonide (Aristocort® C)
Arm Type
Active Comparator
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide (Aristocort® C)
Intervention Description
On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
On Day 1, Day 2, and Day 3, subjects will receive 2 applications of 3 mg/cm2 on the same lesional area, at an interval of approximately 12 ± 2 hours.
Primary Outcome Measure Information:
Title
Change from baseline in pruritus NRS on AD lesions
Description
The intensity of pruritus will be evaluated using a NRS by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Change from baseline in pruritus NRS on AD lesions
Description
The intensity of pruritus will be evaluated using a NRS (Numeric Rating Scale) by asking subjects to assign a numerical score to the worst level of itching at each application area in the past 12 hours, on a scale from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
Time Frame
12, 24, 36, 48, and 60 hours
Title
Change from baseline in skin biomarkers for AD
Description
An untargeted biomarker approach with gene expression profile of treated and untreated skin samples will be performed.
Time Frame
Day 2, Day 3, and Day 4
Title
Change from baseline in TSS
Description
The TSS (Total Sign Score) is an assessment of the severity of erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and dryness, each scored independently using the 4-point severity scale with a value range from 0 to 3 (clear to severe). The rating for each parameter is then summed to create a score ranging from 0 to 18.
Time Frame
Day 4
Title
Change from baseline in TAA
Description
The TAA (Target Areas Assessment) is a 6-point scale with a value range from 0 to 5 (clear to very severe) used to evaluate AD severity at each site of study drugs application.
Time Frame
Day 4
Title
Change from baseline in lesion IGA
Description
The lesion IGA (Investigator Global Assessment) is a 5-point scale with a value range from 0 to 4 (clear to severe) used for the assessment of each target lesion severity.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 18 years of age or older at the time of consent.
Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.
Exclusion Criteria:
Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
Subject has clinically infected AD.
Subject has a Fitzpatrick's Skin Phototype ≥5.
Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator.
Subject is known to have immune deficiency or is immunocompromised.
Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
Subject has a known history of chronic infectious disease.
Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fareheen Chowdhury
Phone
514-521-4285
Ext
341
Email
fchowdhury@innovaderm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bissonnette, MD
Organizational Affiliation
Innovaderm Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovaderm Research Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fareheen Chowdhury
Phone
514-521-4285
Ext
341
Email
fchowdhury@innovaderm.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
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