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

NCT ID: NCT05844618

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2025-03-24

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Triamcinolone Acetonide (Aristocort® C)

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide (Aristocort® C)

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: 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.

Interventions

Triamcinolone Acetonide (Aristocort® C)

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

Vehicle

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Locations

Innovaderm Research Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Inno-5011

Identifier Type: -

Identifier Source: org_study_id