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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovaderm Research Inc.
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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.