Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects with Atopic Dermatitis

NCT05844618 | Completed Phase 4

• 1 other identifier: Inno-5011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; aristocort; triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Secondary Outcomes (5)

• Change from baseline in pruritus NRS on AD lesions

  12, 24, 36, 48, and 60 hours

• Change from baseline in skin biomarkers for AD

  Day 2, Day 3, and Day 4

• Change from baseline in TSS

  Day 4

• Change from baseline in TAA

  Day 4

• Change from baseline in lesion IGA

  Day 4

Study Arms (2)

Triamcinolone Acetonide (Aristocort® C)

ACTIVE COMPARATOR

Drug: Triamcinolone Acetonide (Aristocort® C)

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

Triamcinolone Acetonide (Aristocort® C) DRUG

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.

Triamcinolone Acetonide (Aristocort® C)

Vehicle DRUG

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.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-individual

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: May 9, 2023
• Primary Completion: November 7, 2024
• Study Completion: March 24, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)