Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Vehicle
- Registration Number
- NCT05844618
- Lead Sponsor
- Innovaderm Research Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Triamcinolone Acetonide (Aristocort® C) Triamcinolone Acetonide (Aristocort® C) - Vehicle Vehicle -
- Primary Outcome Measures
Name Time Method Change from baseline in pruritus NRS on AD lesions 72 hours 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
Name Time Method Change from baseline in pruritus NRS on AD lesions 12, 24, 36, 48, and 60 hours 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 lesion IGA Day 4 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.
Change from baseline in skin biomarkers for AD Day 2, Day 3, and Day 4 An untargeted biomarker approach with gene expression profile of treated and untreated skin samples will be performed.
Change from baseline in TSS Day 4 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 Day 4 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.
Trial Locations
- Locations (1)
Innovaderm Research Inc.
🇨🇦Montréal, Quebec, Canada