Clinical trial NCT05844618: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
aristocort
triamcinolone acetonide
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
3. Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. 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:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a Fitzpatrick's Skin Phototype ≥5.
4. 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.
5. Subject is known to have immune deficiency or is immunocompromised.
6. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
7. 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.
8. Subject has a known history of chronic infectious disease.
9. Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.

Primary outcomes:
measure: Change from baseline in pruritus NRS on AD lesions
timeFrame: 72 hours
Secondary outcomes:
measure: Change from baseline in pruritus NRS on AD lesions
timeFrame: 12, 24, 36, 48, and 60 hours
measure: Change from baseline in skin biomarkers for AD
timeFrame: Day 2, Day 3, and Day 4
measure: Change from baseline in TSS
timeFrame: Day 4
measure: Change from baseline in TAA
timeFrame: Day 4
measure: Change from baseline in lesion IGA
timeFrame: Day 4
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: