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

Innovaderm Research

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Triamcinolone Acetonide (Aristocort® C); Drug: Vehicle

Study type: Interventional

Funder types: Other

Identifiers

NCT05844618

Inno-5011

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Triamcinolone Acetonide (Aristocort® C)

Active Comparator group

Treatment:

Drug: Triamcinolone Acetonide (Aristocort® C)

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle